Study protocol for a randomized controlled trial of the Parent–Child Assistance Program: a case management and home visiting program for people using substances during pregnancy
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ABSTRACT:
SUBMITTER: Maher E
PROVIDER: S-EPMC11020811 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:Young children living in historically marginalized families are at risk for becoming adolescents with obesity and subsequently adults with increased obesity-related morbidities. These risks are particularly acute for Hispanic children. We hypothesized that the prevention-focused, socioecological approach of the "Minding the Baby" (MTB) home visiting program might decrease the rate of childhood overweight and obesity early in life. This study is a prospective longitudinal cohort study in which we include data collected during 2 phases of the MTB randomized controlled trial. First-time, young mothers who lived in medically underserved communities were invited to participate in the MTB program. Data were collected on demographics, maternal mental health, and anthropometrics of 158 children from birth to 2 years. More children in the intervention group had a healthy BMI at 2 years. The rate of obesity was significantly higher (P < .01) in the control group (19.7%) compared with the intervention group (3.3%) at this age. Among Hispanic families, children in the MTB intervention were less likely to have overweight or obesity (odds ratio = 0.32; 95% confidence interval: 0.13-0.78). Using the MTB program, we significantly lowered the rate of obesity among 2-year-old children living in low-socioeconomic-status communities. In addition, children of Hispanic mothers were less likely to have overweight or obesity at 2 years. Given the high and disproportionate national prevalence of Hispanic young children with overweight and obesity and the increased costs of obesity-related morbidities, these findings have important clinical, research, and policy implications.
| S-EPMC5810599 | biostudies-literature
Project description:It is unclear if surveillance bias (increased reports to Child Protective Services [CPS] related to program involvement) has a substantial impact on evaluation of home visiting (HV) prevention programs. We estimated surveillance bias using data from Connecticut's HV program, birth certificates, CPS, and hospitals. Using propensity score matching, we identified 15,870 families similar to 4015 HV families. The difference-in-differences approach was used to estimate surveillance bias as the change in investigated reports from the last 6 months of program involvement to the next 6 months. The median age of the children at program exit was 1.2 years (range: 60 days, 5 years). We estimated that 25.6% of investigated reports in the HV group resulted from surveillance bias. We reviewed CPS reports of 194 home-visited families to determine if a home visitor made the report and found that 10% were directly from home visitors. Program evaluations should account for surveillance bias.
| S-EPMC10722865 | biostudies-literature
Project description:This study evaluated the sustained effects of the Research-based Developmentally Informed Parent program (REDI-P) at fifth grade, six years after intervention. Participants were 200 prekindergarten children attending Head Start (55% White, 26% Black, 19% Latinx, 56% male, mean age of 4.45 years at study initiation) and their primary caregivers, who were randomly assigned to a control group or a 16-session home-visiting intervention that bridged the preschool and kindergarten years. In addition, the study explored moderation of sustained effects by parenting risks (e.g., less than high-school education, single-parent status, parental depression, and low parent-child warmth). Growth curves over the course of the elementary years examined outcomes in three domains: child academic performance, social-emotional adjustment, and parent-child functioning. At fifth grade, significant main effects for intervention were sustained in the domains of academic performance (e.g., reading skills, academic motivation, and learning engagement) and parent-child functioning (e.g., academic expectations and parenting stress). Significant moderation by parenting risk emerged on measures of social-emotional adjustment (e.g., social competence and student-teacher relationships); parenting risk also amplified effects on some measures of academic performance and parent-child functioning, with larger effects for children from families experiencing fewer risks. Implications are discussed for the design of preschool home visiting programs seeking to enhance the school success and social-emotional well-being of children living in poverty.
| S-EPMC8168937 | biostudies-literature
Project description:AimTo determine whether a strength-based home-visiting program enhances parent-child interaction during the first year at home for children born extremely preterm (gestational age < 28).MethodsA randomised controlled trial of 130 infants born extremely preterm 2018-2021 in Stockholm, allocated to either the Stockholm preterm interaction-based intervention (SPIBI) (n = 66) or an extended follow-up program (n = 64). The intervention group received ten home visits during the first year by a trained interventionist following SPIBI guidelines: an interaction-based intervention supporting sensitive parental responses to infants' signals. The primary outcome of emotional availability was assessed at 12 months corrected age (CA) using the emotional availability scales (EAS).ResultsAt 1-year CA, data were collected from 115/130 (89%) of the included children. There were no significant group differences in emotional availability at 12 months CA. A secondary analysis showed an effect modifier in families with mothers self-rated as depressed at discharge, with the outcome favouring intervention in the EAS dimension of child involvement.ConclusionThe SPIBI had no significant main effect on emotional availability at 12 months CA. Children of self-reported depressed mothers displayed superior involvement behaviour in the intervention group, prompting further research on risk groups and potential modifications of post-discharge interventions.
| S-EPMC11627441 | biostudies-literature
Project description:Alcohol and Other Drug (AOD) exposure during pregnancy is linked to serious adverse child outcomes, including Fetal Alcohol Spectrum Disorder (FASD). The Parent-Child Assistance Program (PCAP) supports women with problematic AOD use, who are pregnant or have young children, and are not effectively engaging with services. PCAP has been shown to reduce alcohol exposed pregnancies, promote AOD abstinence, increase employment and family planning and improve child outcomes. This manuscript reports the first pilot evaluation of the PCAP program delivered in Australia. A pre-post-intervention repeated measures design was used. Eleven women receiving PCAP from a not-for-profit organisation were invited to take part in the study, with eight providing complete pre-post data. Home visitation case management was provided by trained and experienced case-managers. Clients were assisted to engage with existing services effectively to meet their own goals via a combination of relational theory, motivational interviewing and harm reduction concepts. The PCAP Modified Addiction Severity Index 5th Edition was adapted for use in Australia and was used to measure domains of addiction severity related problems as the primary outcome. Secondary outcomes included client satisfaction and program fidelity. There were significant changes in composite addiction severity scores from baseline to one year. 80% of participants had periods of abstinence of longer than four months. All clients had better connection to services, no subsequent AOD exposed pregnancies, and were highly satisfied with the program. Four had children returned to their care. Implementation was similar to the original PCAP program with major differences including case-managers relying on training manuals only without undertaking in-person training; being more experienced; providing more direct AOD counselling; and having less supervision. The findings will inform future program delivery and methodology for a larger longitudinal study assessing outcomes at program exit.
| S-EPMC10022323 | biostudies-literature
Project description:This study examined three components of parent engagement in an enriched Head Start home visiting program: intervention attendance, the working alliance between parents and home visitors, and parents' use of program materials between sessions. The study identified those family and child characteristics that predicted the different components of parent engagement, and the study tested whether those components predicted sustained growth in children's school readiness skills across four years, from preschool through second grade. Ninety-five low-income parents with four year-old children attending Head Start (56% white; 26% black; 20% Latino; 44% girls) were randomly assigned to receive the home visiting program. Assessments included home visitor, parent, and teacher ratings, as well as interviewer observations and direct testing of children; data analyses relied on correlations and hierarchical multiple regression equations. Results showed that baseline family characteristics, like warm parent-child interactions, and child functioning predicted both working alliance and use of program materials, but only race/ethnicity predicted intervention attendance. The use of program materials was the strongest predictor of growth in children's literacy skills and social adjustment at home during the intervention period itself. In contrast, working alliance emerged as the strongest predictor of growth in children's language arts skills, attention skills, and social adjustment at school through second grade, two years after the end of the home visiting intervention. To maximize intervention effectiveness across school readiness domains over time, home visiting programs need to support multiple components of parent engagement, particularly working alliance and the use of program materials between sessions.
| S-EPMC6430128 | biostudies-literature
Project description:BackgroundIn 2016, Brazil scaled up the Criança Feliz Program (PCF, from the acronym in Portuguese), making it one of the largest Early Childhood Development (ECD) programs worldwide. However, the PCF has not been able to achieve its intended impact. We aimed to identify barriers and facilitators to achieving the PCF implementation outcomes across the RE-AIM dimensions (Reach, Effectiveness or Efficacy, Adoption, Implementation and Maintenance) during the COVID-19 pandemic.MethodsThis comparative case study analysis selected five contrasting municipalities based on population size, region of the country, implementation model, and length of time implementing the PCF. We conducted 244 interviews with PCF municipal team (municipal managers, supervisors, home visitors), families, and cross-sectoral professionals. A rapid qualitative analysis was used to identify themes across RE-AIM dimensions.FindingsFamilies' limited knowledge and trust in PCF goals were a barrier to its reach. While the perceived benefit of PCF on parenting skills and ECD enabled reach, the lack of referral protocols to address social needs, such as connecting food-insecure families to food resources, undermined effectiveness. Questions about whether the social assistance sector should be in charge of PCF challenged its adoption. Implementation barriers exacerbated by the COVID-19 pandemic included low salaries, temporary contracts, high turnover, infrequent supervision, lack of an effective monitoring system, and nonexistence or non-functioning multisectoral committees. The absence of institutionalized funding was a challenge for sustainability.InterpretationComplex intertwined system-level barriers may explain the unsuccessful implementation of PCF. These barriers must be addressed for Brazil to benefit from the enormous reach of the PCF and the evidence-based nurturing care principles it is based upon.FundingNIH/NICHD.
| S-EPMC10793162 | biostudies-literature
Project description: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.
| S-EPMC8278003 | biostudies-literature
Project description:ImportanceAntisocial behavior and adult criminality often have origins in childhood and are best addressed early in the child's life using evidence-based parenting programs. However, families with additional risk factors do not always make sufficient changes while attending such programs; these families may benefit from additional support.ObjectiveTo evaluate the efficacy of adding a 10-session, structured home parent support (HPS) intervention to enhance outcomes for high-risk families attending the Incredible Years Parent (IYP) program.Design, setting, and participantsA randomized clinical superiority trial of 126 parents of children aged 3 to 7 years with conduct problems compared the IYP program plus HPS with treatment as usual of the IYP program alone. Child behavior measures were collected before and after treatment and at the 6-month follow-up. Recruitment from 19 IYP groups began February 13, 2013, and follow-up data collection was completed June 4, 2015. All data were analyzed using an intention-to-treat design with last observation carried forward. Statistical analysis took place from May 20, 2015, to March 31, 2016.InterventionParents were randomly assigned to receive IYP program plus HPS or IYP alone.Main outcomes and measuresThe primary outcome measure was the posttreatment change in Eyberg Child Behavior Inventory Total Problem Scale (ECBI-P) score. Secondary outcomes included maintenance of change on the ECBI-P score, ECBI Intensity Scale score, and Social Competence Scale score at the 6-month follow-up; percentage of child behavior scores in the clinical range after treatment; retention; and attendance.ResultsA total of 126 parents (112 women and 14 men; mean [SD] age, 34.7 [8.4] years) were included; 63 parents were randomly assigned to each intervention group. Analysis of variance using intention to treat showed no significant difference between groups after treatment (P = .62). At follow-up, there was a medium effect (d = 0.63) showing a significant benefit from IYP plus HPS of 3.6 (95% CI, 0.8-6.5) on the ECBI-P score (F1,124 = 6.3; P = .01). Families receiving the IYP plus HPS intervention had significantly fewer children with child behavior scores in the clinical range after treatment (9 of 51 [17.6%]) compared with families receiving the IYP program alone (18 of 45 [40.0%]), and this status was maintained at follow-up. The HPS intervention had better retention than the IYP program (dropout, 7 [5.6%] vs 16 [12.7%]) as well as better attendance.Conclusions and relevanceIn this trial, the IYP plus HPS intervention significantly improved outcomes for the most vulnerable families at 6 months. This study demonstrated that the HPS intervention is an effective addition to the IYP program to improve engagement and implementation of IYP program strategies and enhance child behavior outcomes for the most vulnerable families.Trial registrationhttp://anzctr.org.au Identifier: ACTRN12612000878875.
| S-EPMC6439828 | biostudies-literature
Project description:The present study is one of the largest quasi-experimental studies to date on the effects of home visiting on documented child maltreatment during a child's first two years of life. In this matched comparison group study, we compare 8796 families that participated in a home visiting program (HV families) to 8796 similar non-participating families (non-HV families) selected from birth records using Coarsened Exact Matching. Using sequential logistic regression, we identify that HV families have significantly higher odds of experiencing a child maltreatment investigation by their child's second birthday compared to non-HV families; however, among those that were investigated, HV families have significantly lower odds of having their first investigation substantiated for maltreatment. Overall, HV families do not differ significantly from non-HV families in the odds of experiencing a substantiated investigation over 2 years. We share implications for considering surveillance bias, and we highlight the importance of including both substantiated and unsubstantiated investigations when studying the effects of home visiting on documented child maltreatment.
| S-EPMC11894884 | biostudies-literature