Integrated Model for Promoting Parenting and Early School Readiness in Pediatrics

NCT02459327 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 403

Last updated 2025-10-16

No results posted yet for this 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-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.

Conditions

  • Infant Behavior
  • Child Behavior
  • Parenting
  • Child Rearing
  • Depression
  • Personal Satisfaction
  • Behavioral Symptoms
  • Social Control, Informal

Interventions

BEHAVIORAL

Video Interaction Project

VIP utilizes pediatric well-child visits to build a relationship with an interventionist who facilitates self-reflection regarding interactions with the child through review of videotapes of the parent and child made that day and further facilitates interactions through provision of learning materials (toys and books).

BEHAVIORAL

Family Check Up

FCU utilizes home visitation to build a relationship with an interventionist who assesses family strengths and challenges and uses motivational interviewing and evidence-based family management strategies to support parent and child behavioral change.

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER
  • NYU Langone Health

    collaborator OTHER
  • New York University

    lead OTHER

Principal Investigators

  • Pamela Morris, Ph.D · New York University

  • Alan Mendelsohn, MD · NYU Langone Health

  • Daniel Shaw, Ph.D · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-03
Primary Completion
2025-05-09
Completion
2025-05-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02459327 on ClinicalTrials.gov