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NCT02459327 · ClinicalTrials.gov registry record · NA
Integrated Model for Promoting Parenting and Early School Readiness in Pediatrics
A NA study of Depression and Parenting, sponsored by New York University.
- Completed
- Registry status
- NA
- Development phase
- 403
- Enrollment target
- 2
- Study locations
NCT02459327 is a NA study of Depression and Parenting that has completed, run by New York University. The registered enrollment target is 403 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (49% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT02459327, a NA study of Depression and Parenting, has completed, sponsored by New York University.
- COMPLETED
- Registry status
- NA
- Development phase
- 403 participants
- Enrollment target
- 2
- Study locations
Study Summary
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-acade
Conditions Studied
Interventions
- BEHAVIORAL Family Check Up
- BEHAVIORAL Video Interaction Project
Study Locations (2)
New York
- Bellevue Hospital Center - New York
Pennsylvania
- Children's Hospital of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 403 participants |
| Start Date | 2015-06-03 |
| Est. Completion | 2025-05-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02459327
The ClinicalTrials.gov registry entry for NCT02459327 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 403 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (49% lower). The listed sponsor is New York University, which has 83 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Family Check Up is the first listed.
NCT02459327 reports 2 study locations spanning 2 distinct geographic areas - top geographies include New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02459327 about?
NCT02459327 is a clinical study titled "Integrated Model for Promoting Parenting and Early School Readiness in Pediatrics". 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 platfor...
What is the current status of trial NCT02459327?
This trial is currently completed. It is a NA study. The enrollment target is 403 participants. The study started on 2015-06-03. Estimated completion is 2025-05-09.
What conditions does trial NCT02459327 study?
This clinical trial studies the following conditions: Depression, Parenting, Child Behavior, Behavioral Symptoms, Infant Behavior.
What interventions are being tested in trial NCT02459327?
The interventions under investigation include: Family Check Up (BEHAVIORAL), Video Interaction Project (BEHAVIORAL).
Who is sponsoring clinical trial NCT02459327?
This trial is sponsored by New York University, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02459327 being conducted?
This trial has 2 study locations across New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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