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Parenting Interventions for Early Childhood Development

N/A
Waitlist Available
Led By Alan Mendelsohn, MD
Research Sponsored by New York University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Family attended second (follow-up) meeting with study team between when the child was aged 10days and 6weeks old
Family can be contacted (has a working phone)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up when the child is 4 years old - 6 years old
Awards & highlights

Study Summary

This trial tests an integrated approach to promoting school readiness in low-income families, beginning shortly after the child's birth. The intervention is delivered through the pediatric primary care platform and includes 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.

Who is the study for?
This trial is for low-income families with newborns receiving care at Bellevue Hospital Center or Pittsburgh Children's Hospital. The caregiver must speak English or Spanish, have a working phone, and attend a follow-up meeting when the child is 10 days to 6 weeks old. Exclusions include multiple births, low birth weight, genetic abnormalities, early intervention criteria at birth, significant postnatal complications, prior participation in VIP/FCU projects.Check my eligibility
What is being tested?
The study tests an integrated approach to improve school readiness by enhancing parenting practices through two interventions: Video Interaction Project (VIP) and Family Check-Up (FCU). VIP involves videotaping parent-child interactions during pediatric visits while FCU offers home-based coaching on parenting. The effectiveness of these combined strategies will be evaluated in a randomized trial involving 400 families.See study design
What are the potential side effects?
Since this trial focuses on educational and behavioral interventions rather than medical treatments, there are no traditional side effects like those associated with medications. However, participants may experience changes in family dynamics or stress levels due to the nature of the interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My family and I met with the study team for a follow-up when my child was between 10 days and 6 weeks old.
Select...
My family can be reached by phone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~when the child is 4 years old - 6 years old
This trial's timeline: 3 weeks for screening, Varies for treatment, and when the child is 4 years old - 6 years old for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Caregiver depression
Caregiver stress/ support
Caregiver's cognitive stimulation
+8 more
Secondary outcome measures
Basic child health
Caregiver Mindfulness
Caregiver confidence
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: VIP/FCUExperimental Treatment2 Interventions
VIP (Video Interaction Project) will be offered to all families assigned to the treatment group. FCU (Family Check Up) will be offered to families identified as high risk within the treatment group. Both treatments are parenting interventions.
Group II: ControlActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Family Check Up
2017
Completed Phase 1
~640
Video Interaction Project
2005
N/A
~680

Find a Location

Who is running the clinical trial?

NYU Langone HealthOTHER
1,358 Previous Clinical Trials
816,410 Total Patients Enrolled
1 Trials studying Parenting
32 Patients Enrolled for Parenting
University of PittsburghOTHER
1,712 Previous Clinical Trials
16,346,008 Total Patients Enrolled
4 Trials studying Parenting
24,124 Patients Enrolled for Parenting
New York UniversityLead Sponsor
224 Previous Clinical Trials
311,582 Total Patients Enrolled
2 Trials studying Parenting
3,865 Patients Enrolled for Parenting

Media Library

Family Check Up Clinical Trial Eligibility Overview. Trial Name: NCT02459327 — N/A
Parenting Research Study Groups: VIP/FCU, Control
Parenting Clinical Trial 2023: Family Check Up Highlights & Side Effects. Trial Name: NCT02459327 — N/A
Family Check Up 2023 Treatment Timeline for Medical Study. Trial Name: NCT02459327 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for volunteers in this research endeavor?

"The details listed on clinicaltrials.gov state that this particular study is no longer recruiting participants, though it was initially posted back in June 2015 and last updated November 2022. Although there are 1279 other studies actively seeking patients at the moment."

Answered by AI

What are the ultimate objectives of this research endeavor?

"This medical trial aims to evaluate the primary outcome of prosocial and problem behaviour in children aged 4 - 6 years old. Secondary outcomes include assessments of child temperament, caregiver reports on early intervention services received, and basic health such as attendance in well-child care visits."

Answered by AI
Recent research and studies
~11 spots leftby Jun 2024