A UK case-control study of the Mellow Babies effectiveness: An attachment-based early intervention parenting programme for Mums & Dads

Not Applicable

Completed

Conditions: Parental mental health, child social-emotional development, parent-child relationship and social inclusion.
Mental and Behavioural Disorders

Registration Number: ISRCTN17621046

Lead Sponsor: The AIM Foundation

Brief Summary: 2021 Results article in https://doi.org/10.1371/journal.pone.0245226 results (added 04/02/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36519512/ qualitative data collected as part of the study via semi-structured interviews with parents who completed the MB groups (added 22/12/2022)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 91

Inclusion Criteria

1. Mums and dads
2. Experience complex and additional care needs (e.g. mental health issues, substance misuse, poor parenting, involvement to statutory child protection) and who have at least one child (girl or boy) under the age of 18 months
3. Who are referred by a health-related professional (e.g. health visitor, social worker, midwife, GP) or are self-referred to a family support service with trained Mellow Babies practitioners in the regions of England, Scotland and Nothern Ireland
4. Have been informed about the aims and procedures of the research project and have signed a written consent form
5.1. Attend a Mellow Babies early intervention group starting between 1/2/2017 and 30/6/2017 (Study Group)
5.2. On a waiting list for attending a Mellow Babies group beyond the project's timescale or are receiving another group intervention/ activity (Care as Usual) within the service during the set time period due to reasons such as service's availability/funding (Control Group)

Exclusion Criteria

1. Do not have a child (girl or boy) under the age of 18 months
2. To attend a Mellow Babies early intervention group within the project's timescale, but all or the majority (2 out of 3) of the practitioners facilitating the group have not had a previous Mellow Babies delivery experience. This criterion is applied to ensure fidelity to the Mellow Babies intervention programme.
3. Satisfy the rest of the inclusion criteria but do not wish to take part in the research project

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Quality of parent-child relationship. Interaction is measured using the Mellow Parenting Observation System (MPOS) and Elizabeth Meins & Charles Fernyhough (2015) Mind-Mindedness video observation at baseline and 14 weeks<br>2. Parents attitudes and beliefs about self and relationship with their child will be measured by using a 10 point Likert scale referred to as the the tunnel” at baseline, 7 and 14 weeks

Secondary Outcome Measures

Name	Time	Method
Child:<br>Child social and emotional indicators are measured using Ages and Stages Questionnaire: Social and Emotional (ASQ: SE-2) at baseline and 14 weeks.<br><br>Parent:<br>1. Parental well-being is measured using the Brief Symptom Inventory 18 (BSI-18) and Quality of Life Enjoyment and Satisfaction Questionnaire (Short Form) at baseline and 14 weeks<br>2. Parental confidence is measured using the Karitane Parenting Confidence Scale (KPCS) at baseline and 14 weeks<br>3. Ongoing parental engagement with services is measured using qualitative feedback from parents and professionals at 14 weeks. In addition to data collected through semi-structured interviews, at week 14 group facilitators will provide a Further Service Uptake” and a Group Attendance” sheet for each participant