SCPHRP Final report
SCPHRP reference number:
form for SCPHRP grants
SCPH/13
Please complete this form in Verdana 10 point font size Project title: Antenatal parenting support: an exploratory randomised controlled trial of psychosocial antenatal programmes. Start date: January 2012
Finish date: June 2013
Investigators: Philip Wilson
Angus MacBeth
Christine Puckering
Sharon McAlees
Lucy Thompson
Marion Henderson
Anne Clarke
1. SUMMARY Social adversity and poor maternal mental health during pregnancy have long-term adverse effects on children’s health, social, educational and economic outcomes. Depression, anxiety and stress in pregnancy may have direct physiological effects on the fetus as well as impairing development of maternal sensitivity to the child. There is a need for improved antenatal support and more effective engagement with ‘high risk’ mothers-to-be. Consecutive women meeting high risk criteria were invited to participate in trial. Participants (n=35) were randomly allocated in clusters of six, to either a Mellow Bumps group, an active comparison group (Chill-out in Pregnancy) or care-as-usual. Mellow Bumps is a six-week group based antenatal parenting programme which aims to decrease maternal antenatal stress levels and emphasise the importance of early interaction in enhancing brain development and attachment. Chill-out in Pregnancy is a six-week group based stress reduction programme. Results suggest that taking part in either a Mellow Bumps group or Chill-out in Pregnancy may contribute to modest improvements in mental health and wellbeing when measured eight to twelve weeks post-birth compared to care-as-usual. 2. ORIGINAL AIMS The original aim of this study was to compare the impact of participation in a Mellow Bumps intervention with that of a control intervention, as well as care-as-usual, on the mental health of pregnant women with additional health and social care needs. 3. METHODOLOGY 3.1. Study Design This was an exploratory study for a three-arm parallel randomised open-label blinded endpoint (PROBE) clinical trial design. Referrals to specialist midwifery services of women in Inverclyde and Ayrshire meeting the Special Needs in Pregnancy (SNiP) criteria used in NHS Greater Glasgow and Clyde were invited to participate. SNiP protocols are largely based on 1
maternal and family factors, so can be readily detected early in pregnancy, making early intervention feasible. It includes women who have previous or current mental health issues, substance misuse, have had previous children who are looked after or accommodated in local authority or kinship care or are involved in the criminal justice system (see appendix 1). These women may have had previous negative experiences with health and/or social services. Consented participants were randomly allocated, in groups of six, to either Mellow Bumps, an active comparison condition – Chill-out in Pregnancy, or Care-as-usual. Participants were offered a £20 shopping voucher at the last data collection point. 3.2. Interventions: The two active interventions were offered in addition to participants’ routine maternity care (Care-as-usual). Mellow Bumps (MB) MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers’ understanding of neonates’ capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks’ gestation, to capture the period when the risk of miscarriage is low and fetal movement felt, but before major preoccupation with the delivery. Chill-out in Pregnancy (ChIP) CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. Like MB, it runs for six weeks at two hours per week. It aims to decrease maternal stress levels. Care-as-usual (CAU) Participants in NHS Greater Glasgow & Clyde received care in line with local Special Needs in Pregnancy protocol. Participants in NHS Ayrshire & Arran received care in line with local Vulnerable Families guidelines. If indicated, a pre-birth case conference was arranged, between weeks 28-32 of the pregnancy, which was followed by either a child protection case conference post-birth or a post-birth planning meeting when necessary. 3.3. Outcome measures Information from participants was collected at three collection time points: pre-intervention (majority within two weeks of the intervention starting), post-intervention (majority within two weeks of the intervention finishing) and 8-12 weeks post-birth. Apart from the infant saliva samples, which community midwives were asked to collect on the fifth postnatal day, the measures were administered face-to-face by the researcher in the participants’ home. Pre-intervention The Adult Wellbeing scale (AWS): generates scores in four domains – depression, anxiety, outward-directed irritability and inward-directed irritability. The dimensions have different cutoff scores that indicate a possible problem in that area (Table 1). Edinburgh Postnatal Depression Scale (EPDS): generates a single score. The cut-off points that suggest that a woman may have depression are detailed in Table 1.
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Domain
Normal score
Borderline score
AWS-depression AWS-anxiety AWS-outward irritability AWS-inward irritability EPDS
0-3 4-6 0-5 6-8 0-4 5-7 0-3 4-6 0-9 10-12 Table 1: Cut-off scores
Probable problem score 7-15 9-15 8-12 7-12 13-30
Participants were also asked to provide saliva samples, by drooling or spitting into provided receptacles, for cortisol assays. Samples were to be collected on three occasions each day repeated on two days:
(i) Time 1: on waking in the morning (ii) Time 2: 45 minutes after time 1 (iii)Time 3: when retiring to bed for the night Post-intervention AWS, EPDS, saliva samples for cortisol assays 5 days post-birth Saliva samples from infant pre- and post-new born heelprick blood sampling (Guthrie test) for cortisol assays. 8-12 weeks post-birth AWS, EPDS, saliva samples for cortisol assays, mother-baby video, semi-structured interview. 3.4. Ethics The study was reviewed and approved by the NHS West of Scotland Research Ethics Committee (12/WS/0024, 4th April 2012). 3.5. Trial Registration This trial is registered with ClinicalTrials.gov (ID NCT01590212). 4. RESULTS 4.1. Recruitment Pregnant women who met the inclusion criteria were approached by community midwives in one area in NHS Greater Glasgow & Clyde and in NHS Ayrshire & Arran. If potential participants were agreeable their details were passed on to the researcher who arranged to visit them at home to discuss the project further. Originally, it was planned to run two MB groups, two CHiP groups and two CAU ‘groups’; one of each in each area with eight women in each group, n=48. Recruitment was slower than anticipated for a number of reasons:
(i) The period available for recruitment was substantially shortened because of a prolonged dispute between Disclosure Scotland and NHS R&D: Disclosure Scotland would only provide Basic Disclosure whereas NHS R&D required Enhanced Disclosure for access to the sites. Ultimately the researcher’s Enhanced Disclosure for another post was accepted by NHS R&D as valid evidence.
(ii) The rate of referral was slower than hoped. As a consequence, the target geographic area in NHS Ayrshire & Arran was extended. 3
Eventually, 35 women were recruited to the project. In order to ensure that there were sufficient women at the right stage of pregnancy to make running a group intervention viable, participants were randomly allocated in groups of six to MB, CHiP or CAU. For the final group, randomisation was abandoned to ensure that two CHiP groups would run. Of 31 participants who completed the questionnaires at baseline, 68% (n=21) completed the information at all three time points. Of the remainder two participants completed baseline and post-intervention questionnaires and two completed baseline and 8-12 weeks post-birth measures (see Figure 1: Participant flow diagram. From consent to the final data collection point, 23 participants were retained in the project for between 19 and 34 weeks (mean 27.13, SD 4.495).
Referred n=50 Declined n=11 Failed contact n=4 Recruited n=35 Withdrew n=2 Failed contact n=2 Baseline data n=31 Withdrew n=2 No contact on advice of health professional n=1 Failed contact n=5 Post-intervention data
Contact attempted including failed contacts at post-intervention
Failed contact n=2
Withdrew n=2 No contact on advice of health professional n=1
8-12 week post-birth data n=23
Figure 1: Participant flow diagram
4
4.2. Participants 14 12
Number
10 8 6 4 2 0
19 years or 20-24 years 25-29 years 30-34 years 35-39 years 40+ years less Age group
Figure 2: Participant age groups Age: Participants were aged between 17 and 42 years (mean 27.14, SD 7.49), see Figure 2. Parity: 29% (n=10) participants were first time parents, 51% (n=18) had one or two children and 20% (n=7) had three or more children. Of those who had children, six (24%) had children who were being looked after by the local authority or in kinship care. Social circumstances: 66% (n=23) participants lived in an area that was measured, by the Scottish Index of Multiple Deprivation (SIMD), as one of the 20% most deprived areas. 26% (n=9) lived in the second most deprived quintile. The remainder (8%, n=3) lived in the second least deprived area quintile. Primary referral criteria: The majority of participants had mental health issues (48%, n=17) or there were child protection concerns (23%, n=8), see Figure 3. Even though this was the participants’ primary referral criterion, many had complex issues. For example, one had previous child protection concerns as well as a history of substance misuse and involvement with the criminal justice system.
5
18 16 14 12 Number
10 8 6 4 2 0
Child Criminal Substance Care leaver Domestic Mental health issue protection justice (self misuse abuse concerns or partner)
Young person complex
Primary SNiP criteria
Figure 3: Primary SNiP criteria Infants: Gender (n=23): 11 boys, 12 girls Gestation (n=27): 34-41 weeks (mean 39.30, SD 1.81) Birth weight (n=23): 2.21-4.41kg (mean 3.39, SD 0.57)
Group differences at baseline There were no statistically significant differences between the groups at baseline in the geographical area deprivation of their home address (Χ2=2.026, df 4, p0.731), age group (Χ2=6.808, df 10, p=0.743), or primary reason (Χ2=10.73, df 12, p=0.552) for referral to the project (Table 2). Similar comparisons were made between those completing baseline data only and those who were followed up. No significant differences were found (see appendix 2).
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Group allocation
N %
Mellow Bumps 8 80.0%
CHiP 5 55.6%
Care-asusual 7 58.3%
Total 20 64.5%
N % N % N %
1 10.0% 1 10.0% 1 10.0%
3 33.3% 1 11.1% 1 11.1%
4 33.3% 1 8.3% 1 8.3%
8 25.8% 3 9.7% 3 9.7%
N % 25-29 years N % 30-34 years N % 35-39 years N % 40+ years N % SNiP Mental health N issue %
4 40.0%
3 33.3%
4 33.3%
11 35.5%
3 30.0%
1 11.1%
2 16.7%
6 19.4%
2 20.0%
1 11.1%
1 8.3%
4 12.9%
0 0%
1 11.1%
3 25.0%
4 12.9%
0 0% 5 50.0%
2 22.2% 4 44.4%
1 8.3% 7 58.3%
3 9.7% 16 51.6%
Child protection N concerns % criminal justice N self or partner % substance misuse N % care leaver N % domestic abuse N % young person N complex % N
2 20.0%
3 33.3%
2 16.7%
7 22.6%
1 10.0%
1 11.1%
1 8.3%
3 9.7%
2 20.0%
0 0%
0 0%
2 6.5%
0 0%
1 11.1%
0 0%
1 3.2%
0 0%
0 0%
1 8.3%
1 3.2%
0 0% 10
0 0% 9
1 8.3% 12
1 3.2% 31
SIMD Quintile 1 = 1 most deprived, 5 = least deprived 2 4 Age groups
19 years or less 20-24 years
Primary criteria
Total
Table 2: Geographic deprivation, age groups and primary SNiP criteria by group allocation Analysis by independent samples t-test suggested that there was no statistical significant difference between the mean age of the participants in each group and the length of time they were retained in the project (see appendix 2). However, participants who were allocated to a MB group seemed more likely to be a first time parent compared to those allocated to CHiP or CAU (Table 3).
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First time parent
Count % within allocation Count % within allocation Count
Experienced parent
Total
Group allocation Mellow Bumps CHiP 4 2 Group 40.0% 22.2% 6 Group 60.0% 10
Care-asusual 2 16.7%
Total 8 25.8%
7
10
23
77.8%
83.3%
74.2%
9
12
31
Table 3: First-time parent by group allocation Also, those allocated to an intervention group were more likely to have had a previous child in local authority or kinship care (Χ2 5.087, df 2, p<0.1).
Previous yes children looked after or accommodated no
Total
Count % within allocation Count % within allocation Count
Group allocation Mellow Bumps CHiP 2 3 Group 33.3% 42.9%
Care-asusual 0 0%
Total 5 21.7%
4 Group 66.7%
4 57.1%
10 100.0%
18 78.3%
7
10
23
6
Table 4: Previous children looked after or accommodated by group allocation The box plots (Figure 5 -Figure 9) appear to show differences in the baseline measures between the groups. These apparent variations were examined by undertaking an independent samples t-test (see appendix 2). No differences were significant at p<0.05. 4.3. Outcome Measures Baseline Questionnaires Baseline
N EDPS score 31 AWS-depression score 31 AWS-anxiety score 31 AWS-outward irritability score 31 AWS-inward irritability score 31
Minimum 0 1 0 0 0
Maximum 21 11 12 10 6
Mean 11.19 5.87 5.94 3.65 2.45
Std. Deviation 6.247 2.513 3.803 2.511 1.823
Table 5: Baseline measures At baseline, 45.2% (n=14) of participants had a score on the EPDS that indicated there was likely problem. A similar number (41.9%, n=13) had scores in the depression dimension of the AWS which indicated a probable issue. In the outward-irritability category of the AWS only 6.5% (n=2) had scores that implied that there was a problem. No participants had high scores in the inward-irritability dimension of AWS Figure 4: Baseline measures â&#x20AC;&#x201C; likely problemsFigure 4, see appendix 2).
8
Figure 4: Baseline measures â&#x20AC;&#x201C; likely problems
Change over time
Figure 5: EPDS scores by group allocation
9
Figure 6: AWS-depression scores by group allocation
Figure 7: AWS-anxiety scores by group allocation
10
Figure 8: AWS-outward irritability scores by group allocation
Figure 9: AWS-inward irritability scores by group allocation
In Figure 5 -Figure 9, it appears that participants in the intervention improvements in the EPDS and some of the AWS subscale scores that were the CAU group (see also appendix 2). In order to adjust for the effect of scores, which appeared to differ between the groups although this was
groups showed not replicated in pre-intervention not statistically 11
significant, an analysis of covariance (ANCOVA) was undertaken. No statistically significant differences (pâ&#x2030;¤ 0.05) between the groups were found when post-intervention scores and scores at 8-12 weeks post-birth were compared to pre-intervention scores (see appendix 2). Cortisol Assays Maternal The saliva samples were unpopular with participants. Feedback suggested that they suspected that the samples might be tested for illicit drugs. As a result, only twelve participants supplied saliva samples at baseline.
Figure 10: Mean cortisol level pre-intervention
The number of saliva samples provided by participants declined at each data collection point; five participants supplied samples post-intervention and only four at the 8-12 week post-birth data collection point (see appendix 2 for descriptive data). The small sample numbers meant that it was not possible to analyse any potential differences in cortisol levels between the groups. Infant Samples of saliva were received from seven infants (a total of 14 samples); it was possible to conduct cortisol assays on six. Only two infants had samples with sufficient saliva at both collection points (pre-and post-Guthrie tests. Feedback from community midwives suggested that collecting the saliva by the laboratoryâ&#x20AC;&#x2122;s preferred method (small plastic pipette) had been extremely difficult and seemed to distress the infants. The lack of samples precluded further data analysis.
Baby pre-Guthrie cortisol (nmol/l)) baby post-Gurthrie cortisol (nmol/l))
N 3
Minimum 2
Maximum 54
Mean 23.33
Std. Deviation 27.227
3
2
18
9.67
8.021
Table 6: Baby cortisol assays
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Mother-baby interaction video Eighteen participants agreed to the researcher filming them whilst they cared for their infant, for example, during feeding or nappy changing. The videos were examined using the Mellow Parenting Observation System (MPOS). Low positive and high negative rates are indicative of possible problems in the relationship1,2. No statistically significant differences were found between the groups (see appendix 2).
MB
CHiP
CAU
-0.1
-0.05
0
Negative interactions (rate per sec.)
0.05
0.1
0.15
0.2
Positive interactions (rate per sec.)
Figure 11: Mother-infant interactions Qualitative feedback At the 8-12 week post-birth data collection point, participants were asked about their antenatal, delivery and postnatal experiences of support, their experiences of the group intervention if they took part and their feelings about taking part in a research project in semistructured interview. Interviews were audio-recorded and transcribed verbatim. The transcripts have just been completed. As a result, there was insufficient time to carry out a rigorous thematic analysis for this report. It is planned that this will be carried out in the near future and written up for publication in a peer-reviewed journal. Preliminary qualitative analysis suggests that, for the majority of the participants it was an unplanned pregnancy. Participants were concerned about how they would cope. For a few, there was a worry about the reaction of social services, “I was worried in case I wasn’t going to get to keep him because of what happened before” (PID 107, MB). In general, those that had attended an intervention group viewed the experience positively. Being able to meet other pregnant women in a non-judgemental environment was valued, 13
“the ladies (group facilitators) didnae judge…I thoroughly enjoyed it…it was fun…the ladies were very supportive and I would highly recommend it (CHiP)” (PID 118, CHiP) The activities of the groups had provided opportunities to relax as well as learn, “we done the desert island task thing with the play dough…it was calming, it calms you down, it makes you forget about everything else that’s all bad, and you’re just concentrating on the good…your mind’s no’ thinking about the negatives, you’re thinking about the positives and the future, things like that” (PID 122, CHiP) “we were watching the DVD and it was aboot…you talking to your child and all that, aboot the brain cells…I found that very, very interesting…that amazed me that DVD…I’m different wi’ him (this baby) than I was wi’ the rest of thaim…I spend mair time talking to him…I’ve got four kids and it made me sit and think…I could spend a wee bit extra time wi’ thaim in the day, it’s about all those wee extra brain cells” (PID 107, MB) In addition, for this participant, the CHiP group had provided practical support, “CHiPs (sic) helped me to get a pram and a car seat and different things that I needed and didn’t have the money for” (PID 123, CHiP). Furthermore, this participant was continuing to use the relaxation techniques that she had learnt in the group to help her cope with everyday situations, “I panic quite a lot when I’m out and now I don’t care, I’ll stop and I’ll breathe…breathe the way they taught me…just to calm down” (PID 123, CHiP). It seems that taking part had had short term benefits as well as potential longer term positive outcomes. As a reflection, perhaps, of the value placed on the group, many of the participants mentioned that they felt that a six week period for the programme was too short. 5. DISCUSSION The results presented in this report suggest that taking part in either a Mellow Bumps or Chillout in Pregnancy group had positive effects on the mental health and wellbeing of women who are vulnerable in pregnancy. Previous research has demonstrated that maternal mental health and wellbeing impacts on child development3. In particular, depression impairs maternal sensitivity and atunement to an infant’s needs with subsequent potential problems with attachment. Insecure attachment is a risk factor for later emotional behaviour problems 4. Even though the size of the sample means that the results should be interpreted with a degree of caution, this study suggests that these group programmes were effective in helping women facing social adversity and their infants. No significant inter-group differences were found in analysis of video interactions at 8-12 postnatal weeks, but numbers were small and no baseline video data were available. Traditional antenatal education programmes tend to fail to engage with women who face social adversity5. In this study, participants with significant health and social care needs were recruited. Feedback from those that took part in the groups has been positive suggesting that the format of the programmes was acceptable to this population. Furthermore, this study has served as a useful exploratory study assessing the feasibility of recruiting to a randomised trial of Mellow Bumps. Many of the lessons have informed the development of the Trial of Healthy Relationships in Very-Early years (THRIVE) project. Limitations
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The findings of this feasibility study should be considered in the light of the following limitations. Firstly, this study was limited to participants living in one health board area and one community health care partnership (CHCP) in the west of Scotland. It is possible that the working practices of community midwives may have differed from other potential settings. Secondly, all the participants were actively engaged with health services when they were recruited to the study. It was not possible to identify individuals who were reluctant to engage with midwives. Thirdly, the method used to recruit participants may have compromised the dependability of the findings. Midwives were asked to identify individuals and refer them to the project. It is possible that the participants approached were only those that were thought to be likely to take part in the group programmes. Lastly, it is possible that participants answered the questionnaires in a way that they felt would be received positively by either the research team or health and social service professionals. Challenges This project faced a number of challenges from the outset. The delay in gaining access to research sites for the reasons outlined in section 4.1 had repercussions for this study as it was time-limited. The time period available for recruitment and follow-up was reduced significantly. The geographical distance between the two research sites meant that having an nhs.net email account was invaluable to enable personal information to be passed securely between the researcher and practitioners. As this is a hard-to-reach population, considerable perseverance was needed to make contact at the different stages of the project. Text messaging was used to confirm, re-arrange and remind participants of researcher appointments. 6. CONCLUSIONS The aim of this study was to carry out an exploratory randomised controlled trial of a social intervention with a very ‘hard-to-reach’ population. The results suggest that psychoeducational interventions in pregnancy may benefit women with major psychosocial needs. We have demonstrated that undertaking a randomised trial in this population is feasible. 7. IMPORTANCE TO POLICY & PRACTICE AND POSSIBLE IMPLEMENTATION Providing group-based parenting support in a format acceptable to pregant women with additional health and social care needs may impact on their mental wellbeing in the short and longer term, but a definitive trial is required. 8. FUTURE RESEARCH This project has acted as a feasibility study for the THRIVE project which has been funded by the National Institute for Health Research (£1.9M) and is hosted by the MRC/CSO Social Public Health Sciences Unit (SPHSU), University of Glasgow. 9. DISSEMINATION The preliminary results of this study have been presented at conferences such as the Scottish School of Primary Care annual conference in Inverness in April 2013. A dissemination event is planned for August 2013 to which stakeholders along with practitioners will be invited. The study will be written up for publication in a peer-reviewed journal. 10. RESEARCH WORKERS Jane White was employed by the University of Glasgow to work on this project 0.6wte for a period of fifteen months from January 2012. From April 2013, she has been employed by MRC/CSO SPHSU (now University of Glasgow) to work on the THRIVE project. The PI (Dr Marion Henderson) has allowed Jane to complete data collection in conjunction with working on THRIVE. 15
The Scottish Mental Health Research Network provided research assistant support to help transcribe the qualitative interviews. 11. ACKNOWLEDGEMENTS This project would not have been possible without the help and support of numerous people. We would like to thank: •
The women who have agreed to take part.
•
Elaine Moore, Anne Clarke, Karen Bell, Mary Garven, Marion Dodd, Beth Donnelly, Alison Barr, Jean Reid, and the community midwives who have helped to recruit participants, NHS Ayrshire & Arran.
•
Anne Jamieson, Catriona McLean, Morag McPhail, Rose Sloan, Joanne McGarry, Karen Smith, Halina McIntyre, NHS Greater Glasgow & Clyde.
•
Rosemary Mackenzie, Harriet Waugh and the Mellow Parenting team who trained the group facilitators, developed the Chill-out in Pregnancy programme for this study and have provided on-going support.
•
Leona Cunningham, Mellow Parenting, who helped with the analysis of the qualitative feedback
•
Elsa Ekevall and Kim Jones, University of Glasgow. 16
•
Caoimhe Clarke, Cat. Nixon, Shona Shinwell, MRC/CSO SPHSU, University of Glasgow
•
The Scottish Collaboration for Public Health Research and Policy who provided the majority of the funding
12. REFERENCES 1. Wilson, P.; Thompson, L.; Puckering, C.; McConnachie, A.; Holden, C.; Cassidy, C.; Gillberg, C. (2010) Parent-child relationships: are health visitors’ judgements reliable? Community Practitioner 83(5), pp22-5. 2. Robertson, J.; Puckering, C.; Parkinson, K.; Corlett, L.; Wright, C. (2011) Mother–child feeding interactions in children with and without weight faltering; nested case control study Appetite 56, pp753–759. 3. Clatworthy J (2012) The effectiveness of antenatal interventions to prevent postnatal depression in high risk women. Journal of Affective Disorders 137 (1–3), pp 25–34. 4. O’Connor TG, Heron J, Golding J, Beveridge M, Glover V (2002) Maternal antenatal anxiety and children’s behavioural/emotional problems at 4 years. Report from the Avon Longitudinal Study of Parents and Children. British Journal of Psychiatry 180, pp502–8. 5. Gagnon AJ, Sandall J (2007) Individual or group antenatal education for childbirth or parenthood, or both. Cochrane Database of Systematic Reviews 2007 (3):CD002869
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APPENDIX 1: Special Needs in Pregnancy (SNiP) criteria • • • • • •
• • • • • •
Substance misuse in last 12 months Alcohol misuse in the last 12 months Woman and or partner in criminal justice system HIV positive Child protection issues/concerns for this baby or any previous children whether or not currently with parent(s) Significant mental health issues such as: o Previous history of bipolar disorder, or previous admission to hospital for treatment of mental illness o Family member with history of bipolar disorder (mother/father/brother/sister) o Current mental health problem for example depression or anxiety disorder Gender based violence Would benefit from social work support Domestic violence with child protection concerns Homeless Living in supported accomodation Young women including those: o Linked to leaving care services with complex needs o With identified or potential child protection concerns o Receiving considerable social work support for complex needs o In youth criminal justice system o Pregnancy conceived under difficult circumstances o Living in supported accommodation o Lacking social support from family/socially isolated o Experiencing mental health ill health o Accommodated by local authority o Linked into leaving care services
18
APPENDIX 2: Data Tables
age groups
19 years or less 20-24 years 25-29 years 30-34 years 35-39 years 40+ years SIMD Quintile 1 = 1 most deprived, 5 = 2 least deprived 4 Parity First time parent Experienced parent Previous children yes LAAC No N/A Primary Mental health SNiP issue criteria Child protection concerns criminal justice self or partner substance misuse care leaver domestic abuse young person complex Total
Those who completed baseline only Two or more times Baseline only 1 2 0 11 2 3 2 3 0 4 1 2 2 19 3 4 1 2 2 6 4 19 1 4 3 15 2 6 3 13 1
3 11 5 5 4 3 21 7 3 8 23 5 18 8
Χ2 2.955, df 5, p=0.707
Χ2 5..135, df 2, p=0.077 Χ2 3.296, df 1, p=0.069 Χ2 0.03, df 1, p=0.862
16
6
7
3
3
1 1 0 0
1 0 1
2 1 1
1
1
6
25
31
0
Χ2
Total
Χ2 5.958, df 6, p=0.428
Table 7: Participants who completed baseline questionnaires only compared to others: age group, geographical deprivation, parity, previous children looked after or accommodated, primary SNiP referral reason
6 25 6 25 6 25 6 25 6
Mean 11.00 11.24 5.50 5.96 6.00 5.92 4.17 3.52 2.50
Std. Deviation 4.561 6.666 2.588 2.541 4.243 3.785 2.137 2.616 1.517
Std. Error Mean 1.862 1.333 1.057 .508 1.732 .757 .872 .523 .619
25
2.44
1.917
.383
N EDPS score pre-intervention AWS depression score preintervention AWS anxiety score preintervention AWS outward irritability score pre-intervention AWS inward irritability score preintervention
Baseline only Two or more times Baseline only Two or more times Baseline only Two or more times Baseline only Two or more times Baseline only Two or more times
Table 8: Participants who completed baseline questionnaires only compared to others: outcome measures
19
Independent Samples t-Test: Baseline only vs others Levene's Test for Equality of Variances t-test for Equality of Means
EDPS score Equal prevariances intervention assumed Equal variances not assumed AWS Equal depression variances score preassumed intervention Equal variances not assumed AWS Equal anxiety variances score preassumed intervention Equal variances not assumed AWS Equal outward variances irritability assumed score preEqual intervention variances not assumed AWS inward Equal irritability variances score preassumed intervention Equal variances not assumed
F Sig. 3.576 .069
.023 .880
.004 .952
.124 .728
1.135 .296
t -.083
95% Confidence Interval of the Difference Sig. (2Mean Std. Error tailed) Difference Difference Lower Upper df 29 .934 -.240 2.888 -6.147 5.667
-.105
10.848
.918
-.240
2.290 -5.289 4.809
-.397
29
.694
-.460
1.159 -2.830 1.910
-.392
7.497
.706
-.460
1.173 -3.196 2.276
.045
29
.964
.080
1.758 -3.516 3.676
.042
7.039
.967
.080
1.890 -4.385 4.545
.560
29
.580
.647
1.155 -1.715 3.008
.636
9.001
.541
.647
1.017 -1.655 2.948
.071
29
.944
.060
.843 -1.664 1.784
.082
9.283
.936
.060
.728 -1.580 1.700
Table 9: Participants who completed baseline questionnaires only compared to others: outcome measures independent samples t-test
20
age at group start date
Group allocation Mellow Bumps N Mean Std. Deviation Minimum Maximum CHiP N Mean Std. Deviation Minimum Maximum Care-as-usual N Mean Std. Deviation Minimum Maximum
Retention weeks
10 25.20 5.391 18 34 9 28.89 8.594 17 40 12
9 27.56 3.712 22 34 5 24.80 4.764 21 30 9
29.00 7.851 18 42
28.00 5.099 19 34
Table 10: Age and retention by group allocation
Independent Samples Test: MB vs CHiP Levene's Test for Equality of Variances
age at group start date
Equal variances assumed Equal variances not assumed Reten Equal tion - variances weeks assumed Equal variances not assumed
F 4.493
1.604
Sig. .049
.229
t -1.134
t-test for Equality of Means 95% Confidence Interval of the Difference Sig. (2Mean Std. Error tailed) Difference Difference Lower df Upper 17 .273 -3.689 3.254 -10.554 3.176
-1.107
13.199
.288
-3.689
3.334
-10.880 3.502
1.207
12
.251
2.756
2.283
-2.218 7.730
1.118
6.768
.302
2.756
2.464
-3.111 8.623
Table 11: Independent t-test baseline demographics Mellow Bumps compared to CHiP
21
Independent Samples Test: MB vs CAU Levene's Test for Equality of Variances
age at group start date
Retenti on weeks
Equal variances assumed Equal variances not assumed Equal variances assumed Equal variances not assumed
F 2.394
Sig. .138
t -1.295
t-test for Equality of Means 95% Confidence Interval of the Difference Sig. (2Mean Std. Error tailed) Difference Difference Lower df Upper 20 .210 -3.800 2.935 -9.922 2.322
-1.340 19.385
1.615
.222
.196
-3.800
2.836
-9.728
2.128
16
.835
-.444
2.102
-4.901
4.012
-.211 14.620
.835
-.444
2.102
-4.936
4.047
-.211
Table 12: Independent t-test baseline demographics Mellow Bumps compared to Care-asusual
Independent Samples Test: CHiP vs CAU Levene's Test for Equality of Variances
age at group start date
Equal variances assumed Equal variances not assumed Retenti Equal on variances weeks assumed Equal variances not assumed
F Sig. .240 .630
.003 .958
t-test for Equality of Means 95% Confidence Interval of the Difference Sig. (2Mean Std. Error tailed) Difference Difference Lower Upper .976 -.111 3.604 -7.653 7.431
t -.031
df
-.030
16.459
.976
-.111
3.653 -7.837
7.615
-1.150
12
.273
-3.200
2.783 -9.264
2.864
-1.174
8.907
.271
-3.200
2.726 -9.376
2.976
19
Table 13: Independent t-test baseline demographics CHiP compared to care-as-usual
22
Baseline
Mellow Bumps
CHiP
Care-asusual
Total
N Mean Minimum Maximum Std. Deviation N Mean Minimum Maximum Std. Deviation N Mean Minimum Maximum Std. Deviation N Mean Minimum Maximum Std. Deviation
EDPS score
AWS depression score
AWS anxiety score
AWS inward irritablity score
10 6.30 3 11 2.791 9 6.78 0 12 3.734 11 5.36 0 12 4.653 31
AWS outward irritability score 10 4.80 1 10 2.821 9 3.11 1 7 2.315 11 3.09 0 6 2.343 31
10 14.10 8 21 4.358 9 11.00 0 20 6.595 11 9.27 1 20 6.987 31
10 7.00 4 11 2.108 9 6.00 2 10 2.550 11 5.00 1 8 2.608 31
11.19 0 21 6.247
5.87 1 11 2.513
5.94 0 12 3.803
3.65 0 10 2.511
2.45 0 6 1.823
AWS outward irritability score
AWS inward irritability score
10 2.80 0 6 2.044 9 2.33 0 5 1.732 11 2.27 0 6 1.902 31
Table 14: Outcome measures at baseline
Post-Intervention
Mellow Bumps
CHiP
Care-asusual
Total
N Mean Minimum Maximum Std. Deviation N Mean Minimum Maximum Std. Deviation N Mean Minimum Maximum Std. Deviation N Mean Minimum Maximum Std. Deviation
EPDS score
AWS depression score
AWS anxiety score
7 10.71 7 20 4.957 6 4.83 1 10 3.251 10 7.90 0 19 6.887 23
7 6.57 4 13 3.309 6 4.67 1 8 2.658 10 5.50 2 10 2.915 23
7 5.29 3 10 2.563 6 3.17 0 8 2.714 10 4.60 0 11 4.061 23
7 3.86 1 9 2.854 6 2.00 0 3 1.265 10 2.80 0 7 2.251 23
7 2.14 0 4 1.574 6 .83 0 2 .753 10 1.20 0 6 1.814 23
7.96 0 20 5.796
5.61 1 13 2.935
4.43 0 11 3.300
2.91 0 9 2.275
1.39 0 6 1.559
Table 15: Outcome measures post-intervention
23
EPDS score 8-12 weeks post-birth Mellow N Bumps Mean Minimum Maximum Std. Deviation CHiP N Mean Minimum Maximum Std. Deviation Care-asusual
Total
N Mean Minimum Maximum Std. Deviation N Mean Minimum Maximum Std. Deviation
AWS depression score
AWS anxiety score
AWS outward irritability score
AWS inward irritability score
9 5.22 0 10 2.906 5 2.80 0 10 4.147 9 5.56 0 16 6.146 23
9 3.44 0 6 1.878 5 3.00 1 7 2.345 7 5.14 1 10 4.259 21
9 3.56 0 6 1.944 5 2.80 0 10 4.087 9 4.00 0 11 4.822 23
9 2.00 0 6 1.936 5 1.60 0 3 1.140 9 2.89 0 5 2.028 23
9 .89 0 3 1.269 5 .80 0 4 1.789 9 .67 0 3 1.118 23
4.83 0 16 4.599
3.90 0 10 2.965
3.57 0 11 3.616
2.26 0 6 1.839
.78 0 4 1.278
Table 16: Outcome measures 8-12 weeks post-birth
Mellow Bumps vs Careas-usual Group allocation EDPS score preintervention AWS depression score pre-intervention
N
Mean
Std. Deviation
Std. Error Mean
Mellow Bumps
10
14.10
4.358
1.378
Care-as-usual Mellow Bumps
11 10
9.27 7.00
6.987 2.108
2.107 .667
Care-as-usual
11
5.00
2.608
.786
AWS anxiety score preintervention
Mellow Bumps
10
6.30
2.791
.883
Care-as-usual
11
5.36
4.653
1.403
AWS outward irritability score pre-intervention
Mellow Bumps
10
4.80
2.821
.892
AWS inward irritablity
Care-as-usual Mellow Bumps
11 10
3.09 2.80
2.343 2.044
.707 .646
score pre-intervention
Care-as-usual
11
2.27
1.902
.574
Table 17: Baseline outcome measures means: Mellow Bumps group compared to Care-asusual group
24
Independent Samples Test: MB vs CAU
EDPS score preinterventi on
Equal variances assumed Equal variances not assumed AWS Equal depressio variances n score assumed preEqual interventi variances on not assumed AWS Equal anxiety variances score pre- assumed interventi Equal on variances not assumed AWS Equal outward variances irritability assumed score pre- Equal interventi variances on not assumed AWS Equal inward variances irritablity assumed score pre- Equal interventi variances on not assumed
Levene's Test for Equality of Variances
F 2.920
.807
6.587
.211
.025
t-test for Equality of Means
Sig. T 0.104 1.876
df
Sig. (2tailed) 19 0.076
Mean Std. Error Difference Difference 4.827 2.573
95% Confidence Interval of the Difference Lower Upper -0.559 10.213
1.918
16.942
0.072
4.827
2.517
-0.485
10.140
0.380 1.920
19
0.070
2.000
1.042
-0.180
4.180
1.940
18.769
0.068
2.000
1.031
-0.159
4.159
0.019 0.552
19
0.588
0.936
1.697
-2.616
4.488
0.565
16.593
0.580
0.936
1.658
-2.567
4.440
0.651 1.516
19
0.146
1.709
1.127
-.651
4.069
1.502
17.601
0.151
1.709
1.138
-.685
4.104
0.877 0.612
19
0.548
0.527
0.861
-1.275
2.329
0.610
18.455
0.549
0.527
0.864
-1.285
2.340
Table 18: Independent t-test baseline outcome measures: Mellow Bumps compared to Careas-usual Chill-out In Pregnancy vs Care-as-usual EDPS score preintervention AWS depression score pre-intervention
Group allocation CHiP
N
Mean
Std. Deviation
Std. Error Mean
9
11.00
6.595
2.198
Care-as-usual CHiP
11 9
9.27 6.00
6.987 2.550
2.107 .850
Care-as-usual
11
5.00
2.608
.786
9
6.78
3.734
1.245
11
5.36
4.653
1.403
AWS anxiety score preintervention
CHiP
AWS outward irritability score pre-intervention
CHiP
AWS inward irritablity
CHiP
score pre-intervention
Care-as-usual
Care-as-usual Care-as-usual
9
3.11
2.315
.772
11
3.09
2.343
.707
9
2.33
1.732
.577
11
2.27
1.902
.574
Table 19: Baseline outcome measure means: Chill-out in Pregnancy compared to Care-asusual groups 25
Independent Samples Test: CHiP vs CAU
EDPS score preintervention
Equal variances assumed Equal variances not assumed AWS Equal depression variances score preassumed intervention Equal variances not assumed AWS anxiety Equal score prevariances intervention assumed Equal variances not assumed AWS Equal outward variances irritability assumed score preEqual intervention variances not assumed AWS inward Equal irritablity variances score preassumed intervention Equal variances not assumed
Levene's Test for Equality of Variances
F 0.093
0.093
1.873
0.104
0.155
Sig. 0.764
0.764
0.188
0.750
0.698
t-test for Equality of Means
T 0.564
Mean Sig. (2- Differenc Std. Error tailed) e df Difference 18 0.580 1.727 3.063
95% Confidence Interval of the Difference Lower Upper -4.709 8.163
0.567
17.579
0.578
1.727
3.045
-4.681
8.135
0.862
18
0.400
1.000
1.161
-1.438
3.438
0.864
17.373
0.399
1.000
1.158
-1.439
3.439
0.737
18
0.471
1.414
1.919
-2.617
5.446
0.754
17.999
0.461
1.414
1.876
-2.526
5.355
0.019
18
0.985
0.020
1.048
-2.181
2.221
0.019
17.304
0.985
0.020
1.046
-2.184
2.225
0.074
18
0.942
0.061
0.822
-1.666
1.787
0.074
17.751
0.941
0.061
0.814
-1.651
1.772
Table 20: Independent t-test baseline outcome measures: Chill-out in Pregnancy compared to Care-as-usual groups
26
Mellow Bumps vs Chillout in Pregnancy EDPS score preintervention AWS depression score pre-intervention AWS anxiety score preintervention AWS outward irritability score pre-intervention AWS inward irritablity score pre-intervention
Group allocation Mellow Bumps CHiP Mellow Bumps CHiP Mellow Bumps CHiP Mellow Bumps CHiP Mellow Bumps
10 9 10 9 10 9 10 9 10
Mean 14.10 11.00 7.00 6.00 6.30 6.78 4.80 3.11 2.80
Std. Deviation 4.358 6.595 2.108 2.550 2.791 3.734 2.821 2.315 2.044
Std. Error Mean 1.378 2.198 .667 .850 .883 1.245 .892 .772 .646
9
2.33
1.732
.577
N
CHiP
Table 21: Baseline outcome measure means: Mellow Bumps compared to Chill-out in Pregnancy group Levene's Test for Equality of Variances
t-test for Equality of Means
Independent Samples Test: MB vs CHiP
EDPS score Equal prevariances intervention assumed Equal variances not assumed AWS Equal depression variances score preassumed intervention Equal variances not assumed AWS Equal anxiety variances score preassumed intervention Equal variances not assumed AWS Equal outward variances irritability assumed score preEqual intervention variances not assumed AWS inward Equal irritablity variances score preassumed intervention Equal variances not assumed
F 1.727
0.261
0.579
0.457
0.258
Sig. 0.206
0.616
0.457
0.508
0.618
T 1.221
Sig. (2Mean Std. Error tailed) Difference Difference df 17 0.239 3.100 2.538
95% Confidence Interval of the Difference Lower Upper -2.256 8.456
1.195
13.648
0.253
3.100
2.595
-2.478 8.678
0.936
17
0.363
1.000
1.069
-1.255 3.255
0.926
15.618
0.369
1.000
1.080
-1.294 3.294
-0.318
17
0.754
-0.478
1.502
-3.647 2.691
-0.313
14.751
0.759
-0.478
1.526
-3.735 2.779
1.416
17
0.175
1.689
1.192
-.827 4.205
1.432
16.878
0.170
1.689
1.180
-.801 4.179
0.534
17
0.601
0.467
0.875
-1.379 2.312
0.538
16.951
0.597
0.467
0.867
-1.362 2.296
Table 22: Independent t-test baseline outcome measures: Mellow Bumps compared to Chillout in Pregnancy groups 27
ANCOVA: Tests of Between-Subjects Effects Dependent Variable: EPDS score post-intervention Type III Sum Source of Squares df Mean Square a Corrected Model 326.389 3 108.796 Intercept 24.691 1 24.691 EPDS PRE GROUP 214.594 1 214.594 ALLOCATION Error 74.056 2 37.028 Total 412.568 19 21.714 Corrected Total 2195.000 23 738.957 22 a. R Squared = .442 (Adjusted R Squared = .354)
F 5.010 1.137 9.883 1.705
Sig. .010 .300 .005 .208
Table 23: EPDS score post-intervention compared to pre-intervention ANCOVA: Tests of Between-Subjects Effects Dependent Variable: EPDS score @ 8-12 weeks Type III Sum of Squares Source df Mean Square Corrected Model 305.493a 3 101.831 Intercept 20.956 1 20.956 EPDS PRE GROUP 278.767 1 278.767 ALLOCATION Error 50.670 2 25.335 Total 159.811 19 8.411 Corrected Total 1001.000 23 465.304 22 a. R Squared = .657 (Adjusted R Squared = .602)
F 12.107 2.491 33.143 3.012
Sig. .000 .131 .000 .073
Table 24: EPDS score at 8-12 weeks post-birth compared to pre-intervention ANCOVA: Tests of Between-Subjects Effects Dependent Variable: AWS depression score post-intervention Type III Sum of Squares Source df Mean Square Corrected Model 82.737a 3 27.579 Intercept 2.941 1 2.941 AWS-depression PRE 70.806 1 70.806 GROUP ALLOCATION 13.037 2 6.518 Error 106.742 19 5.618 Total 913.000 23 Corrected Total 189.478 22 a. R Squared = .437 (Adjusted R Squared = .348)
F 4.909 .524 12.603 1.160
Sig. .011 .478 .002 .335
Table 25: AWS-depression score post-intervention post-birth compared to pre-intervention ANCOVA: Tests of Between-Subjects Effects Dependent Variable: AWS depression score @ 8-12 weeks Type III Sum of Squares Source df Mean Square Corrected Model 35.026a 3 11.675 Intercept 3.157 1 3.157 AWS-depression PRE 18.296 1 18.296 GROUP ALLOCATION 23.288 2 11.644 Error 140.784 17 8.281 Total 496.000 21 175.810 20 Corrected Total a. R Squared = .199 (Adjusted R Squared = .058)
F 1.410 .381 2.209 1.406
Sig. .274 .545 .155 .272
Table 26: AWS-depression score at 8-12 weeks post-birth compared to pre-intervention
28
ANCOVA: Tests of Between-Subjects Effects Dependent Variable: AWS anxiety score post-intervention Type III Sum of Squares Source df Mean Square Corrected Model 3 51.222 153.667a Intercept AWS.336 1 .336 anxiety PRE GROUP 138.676 1 138.676 ALLOCATION Error 24.681 2 12.341 Total 19 4.526 85.986 692.000 23 Corrected Total 239.652 22 a. R Squared = .641 (Adjusted R Squared = .585)
F 11.318 .074 30.643 2.727
Sig. .000 .788 .000 .091
Table 27: AWS-anxiety score post-intervention post-birth compared to pre-intervention ANCOVA: Tests of Between-Subjects Effects Dependent Variable: AWS anxiety score @ 8-12 weeks Type III Sum Source of Squares df Mean Square a Corrected Model 3 50.972 152.915 Intercept AWS4.300 1 4.300 anxiety PRE GROUP 148.285 1 148.285 ALLOCATION Error 2 6.031 12.062 Total 134.737 19 7.091 580.000 23 Corrected Total 287.652 22 a. R Squared = .532 (Adjusted R Squared = .458)
F 7.188 .606 20.911 .850
Sig. .002 .446 .000 .443
Table 28: AWS-anxiety score at 8-12 weeks post-birth compared to pre-intervention ANCOVA: Tests of Between-Subjects Effects Dependent Variable: AWS outward irritability score post-intervention Type III Sum of Squares Source df Mean Square F a Corrected Model 3 27.944 17.702 83.833 Intercept .546 1 .546 .346 AWS-outward 72.464 1 72.464 45.905 irritability GROUP ALLOCATION 2 1.502 .951 3.003 Error 29.993 19 1.579 Total 309.000 23 22 Corrected Total 113.826 a. R Squared = .737 (Adjusted R Squared = .695)
Sig. .000 .563 .000 .404
Table 29: AWS-outward irritability score post-intervention post-birth compared to pre-intervention ANCOVA: Tests of Between-Subjects Effects Dependent Variable: AWS outward irritability score @ 8-12 weeks Type III Sum of Squares Source df Mean Square Corrected Model 3 5.368 16.103a Intercept AWS â&#x20AC;&#x201C; 8.625 1 8.625 outward irritability 1 9.757 9.757 PRE GROUP ALLOCATION 9.293 2 4.647 58.332 19 3.070 Error Total 192.000 23 Corrected Total 74.435 22 a. R Squared = .216 (Adjusted R Squared = .093)
F 1.748 2.810 3.178
Sig. .191 .110 .091
1.514
.246
Table 30: AWS-outward irritability score at 8-12 weeks post-birth compared to pre-interventio
29
ANCOVA: Tests of Between-Subjects Effects Dependent Variable: AWS inward irritability score post-intervention Type III Sum of Squares Source df Mean Square Corrected Model 3 6.326 18.978a Intercept 1 .938 .938 AWS â&#x20AC;&#x201C; inward 12.790 1 12.790 irritability GROUP ALLOCATION 2.998 2 1.499 Error 34.500 19 1.816 Total 98.000 23 Corrected Total 53.478 22 a. R Squared = .355 (Adjusted R Squared = .253)
F 3.484 .517 7.044
Sig. .036 .481 .016
.826
.453
Table 31: AWS-inward irritability score post-intervention post-birth compared to pre-intervention ANCOVA: Tests of Between-Subjects Effects Dependent Variable: AWS inward irritability score @ 8-12 weeks Type III Sum of Squares Source df Mean Square a Corrected Model 4.870 3 1.623 Intercept .235 1 .235 AWS-inward 4.646 1 4.646 irritability PRE GROUP ALLOCATION .056 2 .028 Error 31.043 19 1.634 Total 50.000 23 Corrected Total 35.913 22 a. R Squared = .136 (Adjusted R Squared = -.001)
F .994 .144 2.843
Sig. .417 .708 .108
.017
.983
Table 32: AWS-inward irritability at 8-12 weeks post-birth compared to pre-intervention
30
Group allocation Mellow cortisol level pre-intervention Bumps day 1, time, 1 (nmol/l)) cortisol level pre-intervention day 1, time 2 (nmol/l)) cortisol level pre-intervention day 1, time 3 (nmol/l)) cortisol level pre-intervention day 2, time 1 (nmol/l)) cortisol level pre-intervention day 2, time 2 (nmol/l)) cortisol level pre-intervention day 2, time 3 (nmol/l)) CHiP cortisol level pre-intervention day 1, time, 1 (nmol/l)) cortisol level pre-intervention day 1, time 2 (nmol/l)) cortisol level pre-intervention day 1, time 3 (nmol/l)) cortisol level pre-intervention day 2, time 1 (nmol/l)) cortisol level pre-intervention day 2, time 2 (nmol/l) cortisol level pre-intervention day 2, time 3 (nmol/l) Carecortisol level pre-intervention asday 1, time, 1 (nmol/l) usual cortisol level pre-intervention day 1, time 2 (nmol/l) cortisol level pre-intervention day 1, time 3 (nmol/l) cortisol level pre-intervention day 2, time 1 (nmol/l) cortisol level pre-intervention day 2, time 2 (nmol/l) cortisol level pre-intervention day 2, time 3 (nmol/l)
N
Minimum Maximum 4 14.1 24.8
Mean 20.275
Std. Deviation 5.0592
4
4.5
36.0
19.850
12.8868
4
3.7
9.0
5.950
2.2428
4
8.5
24.0
15.875
6.9906
4
6.6
24.5
14.550
7.4011
3
1.8
9.4
5.433
3.8109
1
24.4
24.4
24.400
.
1
12.8
12.8
12.800
.
1
3.9
3.9
3.900
.
1
10.9
10.9
10.900
.
1
19.2
19.2
19.200
.
1
6.5
6.5
6.500
.
7
9.5
30.1
18.643
7.5875
6
7.1
26.4
13.300
6.7219
7
1.2
15.2
5.686
5.9698
6
7.0
27.6
16.800
7.1685
6
3.7
22.8
12.967
7.7668
6
1.3
7.8
3.400
2.2521
Table 33: Pre-Intervention cortisol assays by group allocation
31
Group allocation Mellow Bumps cortisol level postintervention CHiP cortisol level postintervention day 1, (nmol/l) cortisol level postintervention day 1, (nmol/l) cortisol level postintervention day 1, (nmol/l) cortisol level postintervention day 2, (nmol/l) cortisol level postintervention day 2, (nmol/l) cortisol level postintervention day 2, (nmol/l)) Care-as-usual cortisol level postintervention day 1, (nmol/l) cortisol level postintervention day 1, (nmol/l) cortisol level postintervention day 1, (nmol/l) cortisol level postintervention day 2, (nmol/l) cortisol level postintervention day 2, (nmol/l) cortisol level postintervention day 2, (nmol/l)
N
time 1 time 2 time 3 time 1 time 2 time 3 time 1
time 2
time 3
time 1
time 2
time 3
Minimum
Maximu m
Mean
Std. Deviation
Nil Samples 3
7.9
12.8
11.100
2.7731
3
8.4
47.6
23.300
21.2233
3
4.6
18.1
9.300
7.6269
2
16.7
24.0
20.350
5.1619
3
18.4
22.6
21.000
2.2716
3
4.5
9.3
6.633
2.4440
2
13.3
17.8
15.550
3.1820
2
10.5
11.3
10.900
.5657
2
4.4
5.2
4.800
.5657
2
8.8
13.9
11.350
3.6062
2
9.8
13.4
11.600
2.5456
2
6.0
12.4
9.200
4.5255
Table 34: Post-intervention cortisol assays by group allocation
32
Group allocation Mellow cortisol @ day 1, time 1 Bumps (nmol/l) cortisol @ 8-12 weeks day 1, time 2 (nmol/l) cortisol @ 8-12 weeks day 1, time 3 (nmol/l) cortisol @ 8-12 weeks day 2, time 1 (nmol/l) cortisol @ 8-12 weeks day 2, time 2 (nmol/l) cortisol @ 8-12 weeks day 2, time 3 (nmol/l) CHiP cortisol @ 8-12 weeks Care-asusual
cortisol @ 8-12 weeks day 1, time 1 (nmol/l) cortisol @ 8-12 weeks day 1, time 2 (nmol/l) cortisol @ 8-12 weeks day 1, time 3 (nmol/l) cortisol @ 8-12 weeks day 2, time 1 (nmol/l) cortisol @ 8-12 weeks day 2, time 2 (nmol/l) cortisol @ 8-12 weeks day 2, time 3 (nmol/l)
N 2
Minimum Maximum 10.1 11.2
Mean 10.650
Std. Deviation .7778
2
2.8
3.0
2.900
.1414
1
6.2
6.2
6.200
.
2
8.0
19.8
13.900
8.3439
1
3.1
3.1
3.100
.
2
4.4
9.3
6.850
3.4648
Nil Samples 2
8.7
11.8
10.250
2.1920
2
7.8
10.5
9.150
1.9092
2
8.1
18.4
13.250
7.2832
2
6.7
19.9
13.300
9.3338
2
7.3
10.5
8.900
2.2627
2
7.1
10.1
8.600
2.1213
Table 35: 8-12 week post-birth cortisol assays by group allocation
33
Video positive rate per second
Group allocation Mellow Mean Bumps 95% Confidence Interval for Mean
Lower Bound Upper Bound
Median Std. Deviation Minimum Maximum Skewness Kurtosis CHiP Χ22.398, df 2, p=0.302*
Mean 95% Confidence Interval for Mean Median Std. Deviation Minimum Maximum Skewness Kurtosis
Care-asusual
Mean 95% Confidence Interval for Mean Median Std. Deviation Minimum Maximum Skewness Kurtosis
Lower Bound Upper Bound
Lower Bound Upper Bound
Statistic .0750 .0333 .1167 .0850 .04986 .01 .16 .277 -.333
Std. Error .01763
.752 1.481
.1240 .0724 .1756 .1400 .04159 .08 .17 -.297 -2.781
.01860
.1060 .0652 .1468 .1000 .03286 .07 .14 .166 -2.845
.01470
.913 2.000
.913 2.000
* Kruskal Wallis Test
Table 36: Positive mother-infant interactions (rate per sec) by group allocation
34
Video negative rate per second
Mellow Bumps
Mean 95% Confidence Interval for Mean
.0175 Lower Bound
.0043
Upper Bound
.0307
Median
.0200
Std. Deviation
.01581
Minimum
.00
Maximum
.04
Skewness
-.036
.752
-1.682
1.481
.0120
.00800
Kurtosis CHiP
Mean 95% Confidence Interval for Mean
Χ21.097, df 2, p=0.578*
Lower Bound
-.0102
Upper Bound
.0342
Median
.0000
Std. Deviation
.01789
Minimum
.00
Maximum
.04
Skewness
1.258
.913
.313
2.000
.0080
.00374
Kurtosis Care-asusual
.00559
Mean 95% Confidence Interval for Mean Median Std. Deviation
Lower Bound
-.0024
Upper Bound
.0184 .0100 .00837
Minimum
.00
Maximum
.02
Skewness
.512
.913
-.612
2.000
Kurtosis * Kruskal Wallis Test
Table 37: Negative mother-infant interactions (rate per sec.) by group allocation
35