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

The effectiveness of video interaction guidance on maternal-infant interactional quality in postpartum mothers with perinatal mental health illnesses: a pilot randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN26320951
Enrollment
50
Registered
2023-03-16
Start date
2023-03-15
Completion date
Unknown
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Current interventions as of 02/07/2024: A total of around 50-60 mother-infant dyads, where the child is aged 0-12months (inclusive), and the mother is identified to be suffering from one or more mild-
11 or above in the EPDS), the Structured Clinical Interview for DSM-5 (SCID-5) diagnostic assessment will be administered to confirm or refute the presence of a psychiatric disorder, and therefore eli

Sponsors

University of Malta
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Malta

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026