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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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03945552
Enrollment
486
Registered
2019-05-10
Start date
2019-07-23
Completion date
2027-05-10
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Family Research, Healthy

Keywords

Parenting Practices, Parent-Child Relationships, Child Development

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.

Detailed description

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.

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.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Michigan State University
CollaboratorOTHER
University of Michigan
CollaboratorOTHER
Northwestern University
CollaboratorOTHER
NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Approximately 600 potential infant/parent dyads screened for inclusion and exclusion criteria.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Parenting compensatory factors (Assets/vulnerabilities): Parenting Stress6 months to 4 yearsParenting 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.
Positive Parenting Activities6 months to 4 YearsPositive 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.
Parent-child Interaction and relationship6 months to 4 YearsLaboratory 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.
Child Expressive and Receptive Language Development6 months to 4 YearsMeasured through direct assessment of child using the Mullen Scales of Early Learning. The Mullen provides standardized scores (M=50, SD=10). Higher scores better.
Child Social-Emotional Development18 months to 4 yearsMeasured 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

MeasureTime frameDescription
Parent-child interactions and relationship6 months to 4 yearsLaboratory 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)
Naturalistic assessment of parent-child interaction6 months to 4 yearsLENA Home (adult words, conversational turns)
Parent Self-Efficacy Measured by the Parent Reading Beliefs Inventory (PRBI)birth to 4 yearsSelf-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.
Child naturalistic language/narrative development18 months to 4 yearsLaboratory observation of naturalistic assessment of child language/narrative
Child self-regulation18 months to 4 yearsDirect 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).
Negative Parenting Practices6 months to 4 yearsSocolar 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.
Parent Self-Efficacy Measured by the Parenting Self Agency Measure (PSAM)birth to 4 yearsParenting 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
Parent Self-Efficacy Measured by Resiliency (RSA)birth to 4 yearsResiliency 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.
Parenting compensatory factors: Planning and Organization6 months to 4 yearsFeeding, sleeping, media routines and screen time measured by parent survey (PS) using an internal survey (PI Mendelsohn; kappa 0.91).
Parenting compensatory factors: Parenting Interaction Skills and Resources6 months to 4 yearsPlay coded video for VIP-promoted skills measured using VIP observation checklist

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026