Pediatric Parenting Support in Flint
Universal Strengths-Based Parenting Support in Pediatric Health Care for Families With Very Young Children Following the Flint Water Crisis
2 other identifiers
interventional
486
1 country
2
Brief Summary
Public health disasters have disproportionate impacts on low income communities, through pathways that add to those of poverty and associated stressors, and act over extended periods. Very young children are highly vulnerable to long-term impacts on development and mental health in the context of parenting challenges following disasters, yet frequently receive the least attention and resources. This study will test the role of universal parenting support in enhancing young children's development and mental health in Flint, Michigan following the Flint Water Crisis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Jul 2019
Longer than P75 for not_applicable healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2019
CompletedFirst Posted
Study publicly available on registry
May 10, 2019
CompletedStudy Start
First participant enrolled
July 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 10, 2027
December 3, 2025
December 1, 2025
7.8 years
May 8, 2019
December 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Parenting compensatory factors (Assets/vulnerabilities): Parenting Stress
Parenting stress measured by Parent Survey (PS) with the Parenting Stress Index (PSI; α= .82) short form parental distress subscale, range 12-60, higher scores worse.
6 months to 4 years
Positive Parenting Activities
Positive parenting practices measured by parent survey (PS) with the StimQ2's core subscales: Reading (READ), Teaching (Parental Involvement in Developmental Advance), and Responsivity (Parental Verbal Responsivity) Subscales. The StimQ2 is a structured interview. The three subscales are summed to obtain a total score. Total scores can range from 0 to 42 (infant)/46 (toddler)/60 (preschool). Higher score better.
6 months to 4 Years
Parent-child Interaction and relationship
Laboratory observation of semi-structured interactions with real time Parenting Interactions with Children: Checklist of Observations Linked to Outcome (PICCOLO), and Adult-Child Interactive Reading Inventory (ACIRI) coding.
6 months to 4 Years
Child Expressive and Receptive Language Development
Measured through direct assessment of child using the Mullen Scales of Early Learning. The Mullen provides standardized scores (M=50, SD=10). Higher scores better.
6 months to 4 Years
Child Social-Emotional Development
Measured by parent survey (PS) using the Infant-Toddler Social Emotional Assessment (ITSEA). ITSEA is a structured interview that measures 4 domains. Items have a 3-point response scale. Subscales are scored by taking the average of items, and subscales are then added to create an overall score. Scores are standardized on a T-distribution (M=50, SD=10). Higher scores worse, except for Competence domain.
18 months to 4 years
Secondary Outcomes (10)
Parent Self-Efficacy Measured by the Parent Reading Beliefs Inventory (PRBI)
birth to 4 years
Parent Self-Efficacy Measured by the Parenting Self Agency Measure (PSAM)
birth to 4 years
Parent Self-Efficacy Measured by Resiliency (RSA)
birth to 4 years
Parenting compensatory factors: Planning and Organization
6 months to 4 years
Parenting compensatory factors: Parenting Interaction Skills and Resources
6 months to 4 years
- +5 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONCare as usual
Video Interaction Project
EXPERIMENTALVIP 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Infant is receiving pediatric care at Hurley Children's Clinic
- Caregiver can be contacted (has a working phone)
- Infant is three months old or younger at time of enrollment
You may not qualify if:
- Infant very low birth weight (\<1500gm)
- Infant born in non-singleton birth (twin, triplet, etc.)
- Infant has known or suspected significant genetic syndrome or malformation
- Infant has other significant medical or developmental complication or risk (e.g., known neurodevelopmental/neuromuscular disorder likely to affect development)
- Parent/legal guardian not present with infant at visit and/or unable to provide consent
- Parent/legal guardian is not English speaking
- Parent/legal guardian with known significant impairment that will be barrier to communication and participation (e.g., intellectual disability, schizophrenia)
- Parent/legal guardian has previously participated in VIP intervention with another child
- Not planning to stay in Flint area for at least 3 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- Michigan State Universitycollaborator
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
- University of Michigancollaborator
- Northwestern Universitycollaborator
Study Sites (2)
Hurley Children's Hospital
Flint, Michigan, 10016, United States
New York University School of Medicine
New York, New York, 10016, United States
Related Publications (2)
Roby E, O'Connell LK, Griffin MG, Guevara VA, Aviles AI, Larkins BC, Guyon-Harris KL, Hunter LJ, McLoughlin M, Ndee C, Vaca-Condado L, Canfield CF, Miller EB, Mendelsohn AL, Morris-Perez PA, Shaw DS, Gross RS. Promoting early relational health and resilience in pediatric primary care: a qualitative study. Pediatr Res. 2026 Mar 15. doi: 10.1038/s41390-026-04842-7. Online ahead of print.
PMID: 41833975DERIVEDChen Y, Canfield CF, Finegood ED, Gutierrez J, Williams S, O'Connell LK, Mendelsohn A. Family stress model and parenting in infancy: Social support and parenting self-efficacy as resilience factors. J Fam Psychol. 2025 Dec;39(8):1129-1140. doi: 10.1037/fam0001341. Epub 2025 Aug 14.
PMID: 40811117DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Alan Mendelsohn, MD
New York Langone Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2019
First Posted
May 10, 2019
Study Start
July 23, 2019
Primary Completion (Estimated)
May 10, 2027
Study Completion (Estimated)
May 10, 2027
Last Updated
December 3, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will become available after all primary outcomes have been assessed by study investigators. Time frame for availability of data will depend of other researchers' specific requests and community partners needs.
- Access Criteria
- Researchers from accredited academic institutions may request access to the study protocol. Permission and access will be granted on an ad hoc basis.
Given that the proposed research methodology will take place in a community (Flint, MI) with ongoing institutional mistrust following the onset of a community-level disaster (the Flint Water Crisis), the investigators are committed to developing a plan for data sharing that will meet NIH's data sharing requirements while simultaneously meeting the needs of this community. The investigators will work together with the Michigan State University Pediatric Public Health Initiative and its community partners to develop a plan for data sharing that addresses these diverse and important considerations.