Trial of Healthy Relationship Initiatives for the Very Early-years

Not Applicable

Completed

• Conditions: Maternal mental health; parenting; attachment; child maltreatment; child language development; early years; antenatal intervention; social deprivation; pregnancy; child development

• Registration Number: ISRCTN21656568
• Lead Sponsor: HS Greater Glasgow and Clyde (UK)

Brief Summary

2019 realist process evaluation protocol in: https://www.ncbi.nlm.nih.gov/pubmed/31196169 (added 17/06/2019) 2019 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/31412902 (added 16/08/2019) 2021 results in https://pubmed.ncbi.nlm.nih.gov/34134724/ (added 18/06/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-28
• Study Completion: 2019-07-31
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 485

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified