20 Clinical Trials for Various Conditions
This project supports the post-third-grade assessment of 693 children and their families who were enrolled in a randomized trial of a program of prenatal and infancy home visitation by nurses that was epidemiologically and theoretically grounded. The project will determine whether the beneficial effects of the program on maternal, child, and family functioning extend through the early elementary school years, giving particular attention to maternal life-course and children's emerging antisocial behavior. Assessments of the children will be based on both mother and teacher reports. Teachers are independent, natural raters of the children's adaptation to an important social context. There are numerous reasons to expect that, from a developmental perspective, the effects of the program will increase as children experience the increased academic demands associated with entry into third grade. In addressing these questions, the current study will determine the extent to which this program of prenatal and infancy home visitation by nurses can produce enduring effects on maternal and child functioning (giving particular attention to the prevention of early-onset disruptive behavior disorders) in urban African Americans that are consistent with those achieved with whites in a central New York state county in a separate trial of this program conducted over the past 20 years.
To examine the impact of prenatal and infancy home visiting by paraprofessionals and by nurses from child age 2 through 6.
To examine the impact of prenatal and infancy home visiting by nurses from child age 2 through 12.
Universal and broad selective parenting education programs that improve parenting skills, increase parents' understanding of child development, and teach positive child discipline strategies can prevent use of corporal punishment and child physical maltreatment. The proposed research addresses this critical need by investigating brief, relatively low-resource intensive primary prevention parenting programs that can be disseminated widely. By reducing cumulative adverse childhood experiences, which include child physical maltreatment, these interventions are expected to reduce long-term health disparities and risks for major public health problems, such as violence, smoking, obesity, drug abuse, risky sexual behavior, mental health disorders, and heart disease, among others
The aim of this randomized trial is to compare a specially designed children's book to brochures for safe sleep education via clinical providers at a third trimester prenatal obstetric visit. Mothers in the control group will receive a specially designed children's book regarding the importance of reading with their infant at this visit, compared to brochures. Knowledge of safe sleep and home literacy orientation will be assessed at baseline prenatally, and their first postpartum obstetric visit.
The purpose of the study is to determine whether parent training with the Incredible Years Parent Program delivered in pediatric primary care decreases usage of healthcare services for the next year when compared to annual healthcare service use during the two years prior to the parents participating in program.
This study tests a comprehensive approach to the promotion of school readiness in low-income families, beginning shortly after the birth of the child, through enhancement of positive parenting practices (and when present, reduction of psychosocial stressors) within the pediatric primary care platform. The investigators do so by integrating two evidence-based interventions: 1) a universal primary prevention strategy (Video Interaction Project \[VIP\]); and 2) a targeted secondary/tertiary prevention strategy (Family Check-up \[FCU\]) for families with infants/toddlers identified as having additional risks. VIP provides parents with a developmental specialist who videotapes the parent and child and coaches the parent on effective parenting practices at each pediatric primary care visit. FCU is a home-based, family-centered intervention that utilizes an initial ecologically-focused assessment to promote motivation for parents to change child-rearing behaviors, with follow-up sessions on parenting and factors that compromise parenting quality. Two primary care settings serving low-income communities in New York City, NY and Pittsburgh, PA will be utilized to test this integrated intervention in hospital-based clinics, providing information about translation across venues where one of the two interventions has been previously used alone. The investigators plan to test the VIP/FCU model in a randomized trial of 400 families utilizing parent surveys, observational data on parent-child interactions, and direct assessments of children's development, at key points during intervention follow-up. Analyses will address questions of program impact for the integrated program across all families and by key subgroups. The largest single contribution made by this study is to test whether an integrated primary and secondary/tertiary prevention strategy implemented in pediatric primary care can produce impacts on early school readiness outcomes, including social-emotional, pre-academic, and self-regulation. As such, this study has the potential to provide the scientific and practice communities with information about an innovative approach to promoting school readiness skills among low-income children.
Project Dulce is designed to test a new approach to delivering family support, in the context of the primary care medical home. The target population to be served is infants between birth and 6 months old and their families who receive primary care at Boston Medical Center. A dulce family partner will reach infants and families through their routine health care visits during their first six months of life and provide them with support for unmet legal needs, screen infants for developmental problems, screen families for mental health problems, and improve families' knowledge of child development. The control group will receive training on safe sleep and safe transportation for their newborn.
The 2021-2022 Study of Family and Staff Well-Being in Head Start Family and Child Experiences Survey (FACES) Programs (the 2021-2022 Study) builds on FACES 2019, a national study of children and families participating in Head Start programs. In the year following the start of the COVID-19 pandemic, there was a need to understand how children, families, and Head Start staff were faring. The 2021-2022 Study explores child, family, and staff well-being, primarily in the programs that participated in FACES 2019.
The 2021-2022 Study of Family and Staff Experiences in American Indian and Alaska Native Head Start Family and Child Experiences Survey Programs (the 2021-2022 Study) builds on AIAN FACES 2019, a national study of children and families participating in Head Start programs funded through grants to federally recognized tribes and consortia. In the year following the start of the COVID-19 pandemic, there was a need to understand how children, families, and Head Start staff were faring. The 2021-2022 Study explores this with some of the programs that participated in AIAN FACES 2019.
Early Head Start (EHS) Family and Child Experiences Survey - 2018 (Baby FACES 2018) will answer new questions about EHS programs, staff, and families that can guide program technical assistance, management, and policy. It will provide information about EHS programs in the context of the adoption of the new Head Start Early Learning Outcomes Framework. Baby FACES 2018 will consist of two nationally representative cross-sectional samples of programs, centers, classrooms, home visitors, and children and families. It will include surveys of program directors, center directors, teachers, home visitors, and parents; conduct observations of classrooms and home visits, and ask staff and parents to report on children's development.
The American Indian and Alaska Native Head Start Family and Child Experiences Survey (AIAN FACES) 2019 builds on AIAN FACES 2015 (NCT03842111), which was the first national study children and families participating in Region XI Head Start. In consultation with the AIAN FACES Workgroup, Mathematica developed instruments and data collection procedures to assess the school readiness skills of 720 children and survey their parents and Region XI Head Start teachers in fall 2019 and spring 2020; conduct observations in those children's Region XI Head Start classrooms; and survey Region XI Head Start staff in spring 2020. Due to the COVID-19 pandemic, spring 2020 child assessments and classroom observations were canceled after two weeks, while surveys of parents and staff continued.
For over two decades, the Head Start Family and Child Experiences Survey (FACES) has been an invaluable source of information on the Head Start program and the children and families it serves. FACES 2019 extends a previously conducted data collection to a new sample of Head Start programs, families, and children. Mathematica and its partners, Juárez and Associates, Educational Testing Service, and consultants Margaret Burchinal and Martha Zaslow, developed instruments and data collection procedures to assess the school readiness skills of 2,260 children and survey their parents and Head Start teachers in fall 2019 and spring 2020 and conduct observations in Head Start classrooms and survey Head Start staff in spring 2020 and spring 2022. Due to the COVID-19 pandemic, spring 2020 child assessments and classroom observations were canceled while surveys of parents and staff continued. The pandemic and a heightened interest in the Head Start workforce brought a shift in approach and focus to spring 2022 data collection activities. As a result, those activities are not described here and instead are listed under NCT06512740.
The Head Start Family and Child Experiences Survey (FACES) is a major source of information on Head Start programs and the children and families they serve. Since 1997, FACES has conducted studies in a nationally representative sample of Head Start programs, but has historically not included Region XI (programs operated by federally-recognized tribes), whose programs are designed to serve predominantly American Indian and Alaska Native (AI/AN) children and families. The American Indian and Alaska Native Head Start Family and Child Experiences Survey (AI/AN FACES), the first national study of Region XI AI/AN Head Start children and families, is designed to fill this information gap. For more information on FACES, please refer to the ClinicalTrials.gov ID NCT03705377.
For nearly two decades, the Head Start Family and Child Experiences Survey (FACES) has been an invaluable source of information on the Head Start program and the children and families it serves. FACES 2014-2018 is the next phase of this important endeavor. Mathematica Policy Research and its partners, Juárez and Associates, Educational Testing Service, and consultants Margaret Burchinal and Martha Zaslow, developed the instruments and data collection procedures to assess the school readiness skills of 2,400 children and survey their parents and Head Start teachers in fall 2014 and spring 2015 (Classroom + Child Outcomes Core) and conduct observations in 720 Head Start classrooms and survey Head Start staff in spring 2015 and spring 2017 (Classroom Core).
Specific Aims: 1. The primary aims of this study are to conduct formative interviews with teen mothers to inform a targeted adaptation of empirically based weight management and parent training programs for teen mothers for their preschoolers. 2. To conduct a small pilot and post-pilot focus group of the feasibility and acceptability of recruitment and retention methods \& the intervention. Study Hypotheses: Given the small sample size and fact that this is a pilot study, focus will be on estimating effect sizes rather than statistical hypothesis testing. However, the investigators exploratory hypotheses are as follows: 1. (a) The adapted intervention will be more feasible compared to the wellness control condition, with a participant retention rate of ≥80% and an average adherence (attendance at weekly treatment sessions; homework completion 5 weekdays weekly) is ≥ 75%; (b) The adapted intervention will be more acceptable compared to the wellness control condition, based on the Consumer Satisfaction Scale and Therapy Assessment Inventory with ≥90% of the participants responding to the item, "In general how satisfied were you with the intervention?" by choosing "unsatisfied" to "very satisfied." 2. (a) The adapted intervention will result in greater improvements in child behavior and parent-child connectedness compared to the control condition; (b) the adapted intervention versus wellness control condition will result in greater increases in child and teen mother individual as well as joint physical activity and physically active play and greater reductions in individual and joint teen mother and child sedentary behavior (television viewing) from baseline to post-intervention; (c) the greater teen mother and child fruit and vegetable consumption; and reduced child juice and sugar-sweetened beverage consumption from baseline to post-intervention; (d) the adapted intervention versus wellness control condition will result in smaller increases in child BMI percentile and teen mother BMI from baseline to post-intervention; (e) participants who attend higher numbers of intervention sessions will show greater improvements in target outcomes (child behavior, parent-child connectedness, and teen mother and child physical activity, sedentary behavior and BMI); with participants receiving the adapted intervention versus wellness control showing the greatest dose-based improvements.
This study is a longitudinal follow-up of 670 primarily African-American women and their 17-year-old firstborn children enrolled since 1990 in a highly significant randomized controlled trial (RCT) of prenatal and infancy home visiting by nurses. Nurses in this program are charged with improving pregnancy outcomes, child health and development, and maternal economic self-sufficiency. This follow-up examines whether earlier program effects on maternal and child functioning lead to less violent antisocial behavior, psychopathology, substance use and use-disorders, and risk for HIV; whether these effects are greater for those at both genetic and environmental risk; and whether program effects replicate those found with whites in an earlier trial.
The purpose of this study is to determine if an intervention focused on promoting parent-child interaction, parental responsibility, parental commitment of time and energy, and sense of community results in better developmental outcomes for low-income children.
This study will evaluate a program to prevent learning problems in children. The program is an inexpensive public health outreach program designed for families living in poverty and is administered through pediatricians' offices and clinics.
This research study is the continuation of a study started more than 20 years ago. The study was designed to explore the effect that depressed parents have on their children and to better understand the factors that contribute to depression development and maintenance. The study will continue to investigate if children have certain characteristics in early and middle childhood that predict the later development of psychological disorders. In addition, the study will continue looking at the processes responsible for the development of children of parents with and without affective (mood) disorders.