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Parenting Support for Child Development and Mental Health

N/A
Waitlist Available
Led By Alan Mendelsohn, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infant is three months old or younger at time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up birth to 4 years
Awards & highlights

Study Summary

This trial will test whether universal parenting support can help mitigate the long-term impacts of public health disasters on young children's development and mental health.

Who is the study for?
This trial is for infants under three months old receiving care at Hurley Children's Clinic in Flint, Michigan. Caregivers must have a working phone and plan to stay in the area for at least 3 years. Infants with very low birth weight, multiple births, or significant medical conditions are excluded.Check my eligibility
What is being tested?
The study tests how universal parenting support can help young children's development and mental health after the Flint Water Crisis. It involves caregivers interacting with their infants through a program called Video Interaction Project.See study design
What are the potential side effects?
Since this trial focuses on parenting support through video interactions rather than medication or medical procedures, traditional side effects are not applicable. However, there may be indirect impacts on family dynamics or caregiver stress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby is 3 months old or younger.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~birth to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and birth to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Child Expressive and Receptive Language Development
Child Social-Emotional Development
Parent-child Interaction and relationship
+2 more
Secondary outcome measures
Child naturalistic language/narrative development
Child self-regulation
Naturalistic assessment of parent-child interaction
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Video Interaction ProjectExperimental Treatment1 Intervention
VIP is a strengths-based, family-centered intervention that uses pediatric well-child visits to enhance parenting practices/relationships and child development by promoting positive parenting practices such as pretend play, shared reading, and daily routines.
Group II: ControlActive Control1 Intervention
Care as usual
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Video Interaction Project
2005
N/A
~680

Find a Location

Who is running the clinical trial?

Michigan State UniversityOTHER
184 Previous Clinical Trials
600,921 Total Patients Enrolled
University of MichiganOTHER
1,794 Previous Clinical Trials
6,373,430 Total Patients Enrolled
Northwestern UniversityOTHER
1,585 Previous Clinical Trials
916,745 Total Patients Enrolled

Media Library

Video Interaction Project Clinical Trial Eligibility Overview. Trial Name: NCT03945552 — N/A
Family Research Clinical Trial 2023: Video Interaction Project Highlights & Side Effects. Trial Name: NCT03945552 — N/A
Video Interaction Project 2023 Treatment Timeline for Medical Study. Trial Name: NCT03945552 — N/A

Frequently Asked Questions

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

Are enrollment slots still open for this research study?

"According to clinicaltrials.gov, the trial remains open and is actively seeking participants since its initial posting on July 23rd 2019 with a most recent update occurring on January 5th 2022."

Answered by AI

What is the current enrollment capacity of this research endeavor?

"Affirmative. Clinicaltrials.gov corroborates that this trial is actively recruiting, having first been posted on July 23rd 2019 and last updated on January 5th 2022. The study requires 500 individuals to be recruited from two separate sites."

Answered by AI

What primary aims have been set for this research?

"The chief goal of this long-term clinical trial, estimated to last between 18 months and four years is the assessment of Child Expressive and Receptive Language Development. Secondary aims include evaluating Parent Self-Efficacy through surveys such as the PRBI (Parent Reading Beliefs Inventory) or PSAM (Parenting Self Agency Measure), both measured on a 1 - 4 Likert Scale; additionally, an evaluation of parent-child interactions will occur using naturalistic assessments like the LENA Home system which tracks adult words and conversational turns."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
New York
What site did they apply to?
New York University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~73 spots leftby Feb 2025