Promoting healthy beginnings using video interaction guidance for infants of mothers with mental health illnesses the first year following the birth of a child

Not Applicable

• Conditions: The mother-infant interactional quality in women with postpartum mental health disorders and their infants; Mental and Behavioural Disorders

• Registration Number: ISRCTN26320951
• Lead Sponsor: niversity of Malta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-16
• Last Update Posted: 15 July 2024
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Inclusion criteria include mother-infant dyads where the:
1. Women is 18 years or older AND
2. Resident in Malta AND
3. Not receiving any counselling support or any form of psychological interventions AND
4. Baby is aged between 0-11months (inclusive) AND
5. Baby was born at full term (37 weeks or beyond) AND
6. Baby's birth weight was at least 2000 grams.

Exclusion Criteria

1. Women with acute and severe mental mental health pathology (such as psychosis, mania, or active suicidal thoughts or thoughts of harming the baby or others).
2. Women with active drug or alcohol dependence.
3. Women who are unable to consent to participation.
4. Women who are unable to read or converse in the English or Maltese language.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mother-infant interactional quality is measured in terms of maternal sensitivity, mother-infant dyadic synchrony, and relational risk, using the Infant Child-Adult Relationship Experimental Index (Infant CARE-Index) at baseline and immediately post-intervention (approximately 3 months). Each mother-baby film will be coded independently by two international coders with a research-level reliability qualification in this tool. Both coders will not be given any information about the trial, its hypothesis/aims, or participants.

Secondary Outcome Measures

Name	Time	Method
1. Mother-infant bonding measured using the Postpartum Bonding Questionnaire (PBQ) at baseline and post-intervention (approximately 3 months). <br>2. Maternal depressive and anxiety symptoms measured using the EPDS and the GAD-7 at baseline and post-intervention.<br>3. Maternal reflective functioning measured using the Parent Reflective Functioning Questionnaire (PRFQ) at baseline and post-intervention.<br>4. Global psychological distress measured using the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) at baseline and post-intervention.