A home-visiting intervention targeting determinants of infant mental health: the study protocol for the CAPEDP randomized controlled trial in France

Abstract

BackgroundSeveral studies suggest that the number of risk factors rather than their nature is key to mental health disorders in childhood.Method and designThe 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.DiscussionThe 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 registrationCurrent Clinical trial number is NCT00392847.

A study of the effect of training pregnant women about attachment skills on infants’ motor development indices at birth to four months

“…The results of motor deveopment comparison were not statistically significant in infants [18]. In Tubach's study (in contrast to the present study), the intervention did not cause any motor development in infants.…”

“…in fact, bergman et al come to the conclusion that maternal mood and her cortisol level during pregnancy affect the infant's growth and motor development [18]. Alidustishahraki et al stated that training classes and developmental skill sessions have no effect on the evolutionary progress of childrenaged at 7-5 months.…”

Supporting families in challenging contexts: the CAPEDP project

“…The evaluation protocol of this randomized controlled trial is described elsewhere (14). In short, sample size was calculated in order to establish whether the CAPEDP intervention was effective in terms of preventing child mental health problems at the age of two (evaluated using the Child Behavior Check List -CBCL), reducing postpartum maternal depression (evaluated using the Edinburgh Postnatal Depression Scale -EPDS) and promoting a positive home environment (using the Infant/Toddler Home Observation for Measurement of the Environment Inventory -HOME).…”

“…To have sufficient statistical power to evaluate these three primary objectives as well as allowing for possible attrition, 440 subjects were included. This guaranteed, for a two-sided test, α = 0.05, 90% power to detect a 2-point decrease in the EPDS score (from 12 to 10), a 3-point decrease in the CBCL total score (from 48.5 to 45.5) and a 2-point increase in the HOME score (from 25.5 to 27.5) (14).…”

Impact of a Randomized Home‐visiting Trial on Infant Social Withdrawal in the Capedp Prevention Study

“…The Compétences parentales et Attachement dans la Petite Enfance: Diminution des risques liés aux troubles de santé mentale et Promotion de la résilience (CAPEDP) (Parental Skills and Attachment in Early Childhood: Reducing Mental Health Risks and Promoting Resilience) study is the first randomized, controlled trial assessing an evidence‐based, home‐visiting, infant mental health promotion program carried out in France (Tubach et al., ). Enrolled mothers were young (<26 years of age) and primiparous, had sufficient fluency in French to be able to understand the informed consent procedure, and had at least one of three additional risk criteria concerning their future child's mental health: planning to raise the child alone, low socioeconomic status (defined as receiving welfare benefits, or being close to the poverty threshold, i.e., with an income of ≤800 euros per month), and having less than 12 years of schooling.…”