Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03945552

Pediatric Parenting Support in Flint

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Healthy Family Research

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hurley Children's Hospital, Flint, Michigan, United States

Loading trial locations.

About this study

There are three specific aims of this study: Specific Aim 1: Characterize participants' experience of the FWC using ecological (neighborhood-level), geocoded STYH data, ecological indicators of water quality and parent self-report measures. These metrics will be obtained from Speak to Your Health (STYH) survey, a biennial community survey including neighborhood-level measures of stress collected before, during and after the FWC. Specific Aim 2: Assess impacts of strengths-based parenting support (VIP) after a disaster compounding chronic poverty (FWC). Specific Aim 3: Assess variation in VIP impacts in relation to FWC experience.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Video Interaction Project

Behavioral

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.

Primary outcomes

  1. Parenting compensatory factors (Assets/vulnerabilities): Parenting Stress

    Time frame: 6 months to 4 years

    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.

  2. Positive Parenting Activities

    Time frame: 6 months to 4 Years

    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.

  3. Parent-child Interaction and relationship

    Time frame: 6 months to 4 Years

    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.

  4. Child Expressive and Receptive Language Development

    Time frame: 6 months to 4 Years

    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.

  5. Child Social-Emotional Development

    Time frame: 18 months to 4 years

    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.

Secondary outcomes

  1. Parent Self-Efficacy Measured by the Parent Reading Beliefs Inventory (PRBI)

    Time frame: birth to 4 years

    Self-efficacy measured by parent survey (PS) using the Parent Reading Beliefs Inventory (PRBI), Teaching Efficacy subscale (α=.73). PRBI is a structured interview. Items are rated on a 1 to 4 Likert scale. Scores for Teaching Efficacy range from 9 to 36. Higher scores are better.

  2. Parent Self-Efficacy Measured by the Parenting Self Agency Measure (PSAM)

    Time frame: birth to 4 years

    Parenting self-agency measured by PS using the Parenting Self-Agency Measure (PSAM). PSAM is a 5-item questionnaire, with items rated from 1 to 5. Scores range from 5 to 25. Higher scores are better

  3. Parent Self-Efficacy Measured by Resiliency (RSA)

    Time frame: birth to 4 years

    Resiliency measured using the Resiliency Scale for Adults (RSA), Personal Strength and Social Resources subscales. RSA items are scored on a 1 to 5 Likert scale. Subscale scores are averaged across items. Higher scores are better.

  4. Parenting compensatory factors: Planning and Organization

    Time frame: 6 months to 4 years

    Feeding, sleeping, media routines and screen time measured by parent survey (PS) using an internal survey (PI Mendelsohn; kappa 0.91).

  5. Parenting compensatory factors: Parenting Interaction Skills and Resources

    Time frame: 6 months to 4 years

    Play coded video for VIP-promoted skills measured using VIP observation checklist

  6. Parent-child interactions and relationship

    Time frame: 6 months to 4 years

    Laboratory observation of semi-structured interactions with subsequent global coding using the Caregiver-Child Affect, Responsivity, and Engagement Scale (C-CARES) and the Parent Child early Relational Assessment (PCERA)

  7. Naturalistic assessment of parent-child interaction

    Time frame: 6 months to 4 years

    LENA Home (adult words, conversational turns)

  8. Negative Parenting Practices

    Time frame: 6 months to 4 years

    Socolar Discipline Survey (α= .56-.82) will be used to assess harsh discipline punishment. Answers range from 1 (never) to 6 (always), where a higher score indicates great frequency of harsh discipline. A total score is calculated from the sum of all items.

  9. Child naturalistic language/narrative development

    Time frame: 18 months to 4 years

    Laboratory observation of naturalistic assessment of child language/narrative

  10. Child self-regulation

    Time frame: 18 months to 4 years

    Direct observation using subset of executive function (EF) battery for 3-year olds from S.M. Carlson - Dimensional Card Sort (3 incompatible test trials, scored 0/1), Fruit Stroop (mismatched fruit; 3 trials, scored 0-2), and Bear/Dragon: Go/No Go (10 trials, scored 0/1).

    Laboratory observation of child regulation during assessment using the Preschool Self-Regulation Assessment (PSRA).

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Michigan State University
  • Northwestern University
  • University of Michigan

Registry information

Official study title

Universal Strengths-Based Parenting Support in Pediatric Health Care for Families With Very Young Children Following the Flint Water Crisis

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
May 10, 2019
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.