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Child Development and Early Interaction: PERL Research Protocol, a Preventive Home Visiting Program, Randomized Controlled Trial in France.

ABSTRACT: Background: Early childhood is a key period for reducing the social inequalities that affect health. Some parenting support and home visitation programs have proven to be effective in assisting parents during this period. France's Protection Maternelle et Infantile (maternal and child welfare) services (PMIs) are at the heart of this primary prevention and may adapt their intervention to improve parenting support. In this manuscript, we describe the protocol of the PERL study, an intervention based on a home visiting program. Method and design: The PERL study is a single-center, randomized, controlled interventional trial. The aim was to assess the impact of a preventive home visiting program on the development of young children and parent-baby interaction. Visits were made by PMI nurses to 64 randomly recruited families from the general population. All families who had a baby born after 37 weeks of pregnancy between September 2018 and December 2019, and who resided in the trial area were eligible. Participants were randomly allocated to the intervention group or the control group. The PMI nurses made 12 home visits in the first year, 6 in the second year, and 4 in the third and fourth years of the child's life. Primary and secondary outcomes were measured when the child was 4 and 24 months old. These measurements recorded (i) the child's developmental milestones, in particular, language and socio emotional skills, (ii) early interaction, maternal sensitivity, and attachment patterns, (iii) maternal psychopathology including depression. Discussion: This study aims to assess the impact of home visits, made by specifically-trained and supervised nurses, on the child's development and parent-child interactions. Such interventions are complementary to other preventive programs addressing the impact of social inequalities on perinatal health. Placing nurses' professional skills at the center of this project may prove an effective and cost-saving intervention compared to existing programs. The study proposes a prevention model that is in keeping with the principle of reducing social inequalities in health by providing support from the earliest age through public service. Clinical Trial Registration: The clinical trial number is NCT03506971, registered on April 24, 2018.

SUBMITTER: Buchheit S

PROVIDER: S-EPMC8278003 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundPolicy-makers are increasingly seeking rigorous evidence on the impact of programs that go beyond typical health care settings to improve outcomes for low-income families during the critical period around the transition to parenthood and through early childhood.MethodsThis study is a randomized controlled trial evaluating the impact of the Nurse-Family Partnership's expansion in South Carolina. The scientific trial was made possible by a "Pay for Success" program embedded within a 1915(b) Waiver from Medicaid secured by the South Carolina Department of Health and Human Services. This protocol describes study procedures and defines primary and secondary health-related outcomes that can be observed during the intervention period (including pregnancy through the child's first 2 years of life). Primary study outcomes include (1) a composite indicator for adverse birth outcomes including being born small for gestational age, low birth weight (less than 2500 g), preterm birth (less than 37 weeks' gestation), or perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life), (2) a composite outcome indicating health care utilization or mortality associated with major injury or concern for abuse or neglect occurring during the child's first 24 months of life, and (3) an indicator for an inter-birth interval of < 21 months. Secondary outcomes are defined similarly in three domains: (1) improving pregnancy and birth outcomes, (2) improving child health and development, and (3) altering the maternal life course through changes in family planning.DiscussionEvidence from this trial on the impact of home visiting services delivered at scale as part of a Medicaid benefit can provide policy-makers and stakeholders with crucial information about the effectiveness of home visiting programs in improving health and well-being for low-income mothers and children and about novel financing mechanisms for cross-silo interventions.Trial registrationThe trial was registered prospectively on the American Economic Association Trial Registry (the primary registry for academic economists doing policy trials) on 16 February 2016 ( AEARCTR-0001039 ). ClinicalTrials.gov NCT03360539 . Registered on 28 November 2017.

Project description: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.

Project description:IntroductionClinical trials have demonstrated significant impact in reducing weight and incidence of type 2 diabetes mellitus. However, the intensity of these trials limits their scalability to real world settings. The purpose of this study was to embed a lifestyle intervention for overweight and obese mothers within the routine practice of a parent education, home visiting organization.DesignPragmatic trial that used a stratified random design.Setting/participantsOverweight or obese mothers of preschool children located across St. Louis, Missouri, enrolled in Parents As Teachers, a home visiting organization reaching women and children nationwide.InterventionA lifestyle intervention derived from the Diabetes Prevention Program was embedded within Parents As Teachers entitled Healthy Eating and Active Living Taught at Home (HEALTH).Main outcome measuresOutcomes included the proportion of women that achieved 5% weight loss at 24 months and improvements in clinical and behavioral outcomes at 12 and 24 months. Participants were enrolled from 2012 to 2014 and data analysis began in 2016.ResultsWomen in the usual care versus intervention group were significantly less likely to achieve 5% weight loss at 24 months (11% vs 26%, p=0.01). At 12 months, there was a 2.8-kg difference in weight between groups (p=0.0006), and by 24 months a 4.7-kg difference in weight (3.2 [SD=7.6] kg vs -1.5 [SD=8.3] kg, p=0.002); group differences in waist circumference were also evident by 12 months (2.1 [SD=8.4] cm vs -0.7 [SD=9.8] cm, p=0.04) and 24 months (3.8 [SD=10.6] cm vs -2.5 [SD=9.1] cm, p=0.005), as were improvements in behavioral outcomes. There was no difference in blood pressure between groups.ConclusionsHEALTH achieved modest but clinically significant weight loss outcomes, and reduced weight gain in mothers of young children. The scalability of this embedded intervention offers the potential to reach mothers in Parents As Teachers programs nationally.Trial registrationThis study is registered at www.clinicaltrials.gov NCT01567033.

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Child Development and Early Interaction: PERL Research Protocol, a Preventive Home Visiting Program, Randomized Controlled Trial in France.

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