A home-visiting intervention targeting determinants of infant mental health: the study protocol for the CAPEDP randomized controlled trial in France
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Published on: September 22, 2023
Florence Tubach1, Tim Greacen, Thomas Saïas
1AP-HP, Hôpital Bichat, Département d'Epidémiologie et Recherche Clinique, 46 rue Henri Huchard, Secteur Claude Bernard, 75877 Paris Cedex 18, Paris, France. florence.tubach@bch.aphp.fr
Insights
This study investigated a home-visiting program for child mental health in French families facing multiple risks. Psychologists provided support, aiming to improve infant mental health and reduce maternal depression.
Area of Science:
- Child Psychology
- Public Health Interventions
- Developmental Psychiatry
Background:
- Childhood mental health disorders are linked to the number, not type, of risk factors.
- Vulnerable families in urban settings face unique challenges in accessing support.
- Existing healthcare systems may not adequately assess or address infant mental health needs.
Purpose of the Study:
- To evaluate a home-visiting program designed to promote child mental health in a French urban sample with multiple risk factors.
- To assess the program's impact on infant mental health and key mediating variables like maternal depression and the quality of the caregiving environment.
- To describe the protocol for a multicentre randomized controlled trial (PROBE methodology).
Main Methods:
- A randomized controlled parallel trial involving 440 families in a French urban area.
- Eligible pregnant women were young, first-time mothers with at least one risk factor (low education, single-parent intention, low income).
- Intervention included weekly home visits by psychologists from pregnancy until the child's second birthday, alongside usual care.
Main Results:
- Primary outcomes measured child mental health at 24 months, postnatal maternal depression, and quality of the caring environment.
- A subsample of 120 families underwent detailed attachment and caregiver behavior assessments.
- The study protocol was designed to address significant challenges in implementing mental health promotion in a complex social care system.
Conclusions:
- The study represents the first large-scale randomized controlled infant mental health promotion program in France.
- A key feature was the use of psychologists, rather than nurses, for all home visits.
- The program aimed to support vulnerable families within a comprehensive yet under-assessed health and social care system.
Background:
Several studies suggest that the number of risk factors rather than their nature is key to mental health disorders in childhood.
Method And Design:
The objective of this multicentre randomized controlled parallel trial (PROBE methodology) is to assess the impact in a multi-risk French urban sample of a home-visiting program targeting child mental health and its major determinants. This paper describes the protocol of this study. In the study, pregnant women were eligible if they were: living in the intervention area; able to speak French, less than 26 years old; having their first child; less than 27 weeks of amenorrhea; and if at least one of the following criteria were true: less than twelve years of education, intending to bring up their child without the presence of the child's father, and 3) low income. Participants were randomized into either the intervention or the control group. All had access to usual care in mother-child centres and community mental health services free of charge in every neighbourhood. Psychologists conducted all home visits, which were planned on a weekly basis from the 7th month of pregnancy and progressively decreasing in frequency until the child's second birthday. Principle outcome measures included child mental health at 24 months and two major mediating variables for infant mental health: postnatal maternal depression and the quality of the caring environment. A total of 440 families were recruited, of which a subsample of 120 families received specific attachment and caregiver behaviour assessment. Assessment was conducted by an independent assessment team during home visits and, for the attachment study, in a specifically created Attachment Assessment laboratory.
Discussion:
The CAPEDP study is the first large-scale randomised, controlled infant mental health promotion programme to take place in France. A major specificity of the program was that all home visits were conducted by specifically trained, supervised psychologists rather than nurses. Significant challenges included designing a mental health promotion programme targeting vulnerable families within one of the most generous but little assessed health and social care systems in the Western World.
Trial Registration:
Current Clinical trial number is NCT00392847.

