Viewing Study NCT02459327



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Last Modification Date: 2024-10-26 @ 11:44 AM
Study NCT ID: NCT02459327
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-03-06
First Post: 2015-05-26

Brief Title: Integrated Model for Promoting Parenting and Early School Readiness in Pediatrics
Sponsor: New York University
Organization: New York University

Study Overview

Official Title: None
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 secondarytertiary prevention strategy Family Check-up FCU for families with infantstoddlers 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 VIPFCU model in a randomized trial of 400 families utilizing parent surveys observational data on parent-child interactions and direct assessments of childrens 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 secondarytertiary 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None