Maternal mental health
Conditions
Interventions
Current interventions (as of 09/04/2018):
This trial will compare two antenatal parenting interventions with routine care using outcome, process and health economics evaluation.
Enhanced Triple P for
Sponsors
NHS Greater Glasgow and Clyde (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria (as of 09/04/2018): 1. Women identified by midwifery, health and social care professionals and third sector organisations as vulnerable during pregnancy using NHS Greater Glasgow and Clyde Health Board?s Special Needs in Pregnancy protocol. Woman will be recruited after their 12th week of pregnancy. 2. Living within NHS Greater Glasgow and Clyde or NHS Ayrshire and Arran, or living within NHS Lanarkshire and receiving obstetric/maternity care from NHS Greater Glasgow and Clyde or NHS Ayrshire and Arran. 3. Women have a basic understanding of written and spoken English 4. Are able to provide informed consent and are able to engage in and complete the assessments and intervention process. 5. Women must be over 16 years of age to take part (or 14 years with social work support). There is no upper age limit as the study includes all women who are of child bearing age. Previous participant inclusion criteria: 1. Women identified by midwifery, health and social care professionals and third sector organisations as vulnerable during pregnancy using NHS Greater Glasgow and Clyde Health Board?s Special Needs in Pregnancy protocol. Woman will be recruited after their 12th week of pregnancy. If they are allocated to Mellow Bumps they must attend at least 50% of the eight group sessions in order to remain a participant in the trial. If they are allocated to Enhanced Triple P for Baby they must attend at least 50% of the antenatal group sessions and at least 50% of the postnatal one-to-one sessions. 2. Women will have a basic understanding of written and spoken English 3. Are able to provide informed consent and are able to engage in and complete the assessments and intervention process. 4. Women must be over 16 years of age to take part. There is no age limit as the study includes all women who are of child bearing age.
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria (as of 09/04/2018): 1. Women with poor or no comprehension of spoken English will be excluded as Enhanced Triple P for Baby and Mellow Bumps are group-based and require spoken communication between group members. 2. Women who have passed 30 weeks of pregnancy prior to referral are excluded, as this does not allow sufficient time to complete antenatal sessions. 3. Women with acute mental illness, including active psychosis, are also excluded as their mental ill-health may not allow them to fully participate or engage in the group programmes. 4. Women who are unable to provide a contact address (e.g. home, friend/relative address or homeless shelter) are also excluded as it may be difficult to retain them in this longitudinal study. 5. Women who are involved in a child protection order are assessed on a case-by-case basis in consultation with the professional who referred them and their midwife (if not the referrer) to determine whether they would be appropriate to take part in the study. 6. Women who are participating in another trial of antenatal interventions are excluded to avoid any bias in results. Previous participant exclusion criteria: 1. Women with poor or no comprehension of spoken English will be excluded as Enhanced Triple P for Baby and Mellow Bumps are group-based and require spoken communication between group members. 2. Women with active psychosis will also be excluded as their mental ill-health may not allow them to fully participate or engage in the group programmes. 3. Women who are unable to provide a contact address (e.g. home, friend/relative address or homeless shelter) will also be excluded as it may be difficult to retain them in this longitudinal study. 4. Women who are involved in a child protection order will be assessed on a case-by-case basis in consultation with the professional who referred them and their midwife (if not the referrer) to determine whether they would be appropriate to take part in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures (as of 09/04/2018): The primary outcome measures, which will be recorded at the 6 month follow-up, are: 1. Maternal anxiety, depression and outwardly directed irritability will be measured using the Hospital Anxiety and Depression Scale enhanced by the outwardly directed irritability measures of the Adult Wellbeing Scale (HADS+I) 2. Quality of mother-child interaction will be measured using observer-ratings of video-taped interactions using the CARE Index Previous primary outcome measures: The primary outcome measures, which will be recorded at the 6 month follow-up, are: 1. Maternal anxiety, depression and outwardly directed irritability will be measured using the Hospital Anxiety and Depression Scale enhanced by the outwardly directed irritability measures of the Adult Wellbeing Scale (HADS+1) 2. Quality of mother-child interaction will be measured using observer-ratings of video-taped interactions using the CARE Index and Mellow Parenting Observation Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures (as of 09/04/2018): 1. Number of children flagged as ‘at risk’ on the social services risk register, under a child protection plan, taken into local authority care or attending accident and emergency as measured using routinely collected NHS and Social Care Records 2. Child socio-emotional development as measured using the Strengths and Difficulties Questionnaire 3. Comparison of costs and outcomes associated with intervention delivery and routine antenatal care measured using routinely collected (NHS, social care, criminal justice and education) data, the EQ-5D-3L and self-reported patient service use 4. Assessment of programme fidelity; practitioners’ characteristics and motivation; mothers’ engagement; the intervention mechanisms; and contextual factors affecting mother and infant outcomes using self-reported practitioner data, ethnographic observation and semi-structured qualitative interviews 5. Assessment of whether fathers’ involvement or support affects mothers’ engagement with intervention delivery using semi-structured qualitative interviews Previous secondary outcome measures: 1. Maternal anxiety, depression and outwardly directed irritability at 18 month follow-up measured using the Hospital Anxiety and Depression Scale enhanced by the outwardly directed irritability measures of the Adult Wellbeing Scale (HADS+1). 2. Quality of the mother-child interaction at 18 month follow-up measured using observer-ratings of video-taped interactions using the CARE Index and Mellow Parenting Observation Scale. 3. Parent self-efficacy at 6 and 18 months measured by the Karitane Parenting Confidence Scale 4. Language development at 18 months measured by the Sure Start Language Questionnaire 5. Language development at 30 months measured by the Sure Start Language Questionnaire 6. Socio-emotional development at age 30 months routinely measured using the Strengths and Difficulties Questionnaire (SDQ). 7. Long-term education outcom | — |
Countries
Scotland, United Kingdom
Outcome results
None listed