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Clinical Trials/NCT03945552
NCT03945552
Active, not recruiting
Not Applicable

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

NYU Langone Health2 sites in 1 country486 target enrollmentJuly 23, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
NYU Langone Health
Enrollment
486
Locations
2
Primary Endpoint
Positive Parenting Activities
Status
Active, not recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 23, 2019
End Date
May 10, 2027
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

Secondary Outcomes

  • Naturalistic assessment of parent-child interaction(6 months to 4 years)
  • Parenting compensatory factors: Planning and Organization(6 months to 4 years)
  • Negative Parenting Practices(6 months to 4 years)
  • Parent Self-Efficacy Measured by Resiliency (RSA)(birth to 4 years)
  • Parent-child interactions and relationship(6 months to 4 years)
  • Child naturalistic language/narrative development(18 months to 4 years)
  • 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)
  • Parenting compensatory factors: Parenting Interaction Skills and Resources(6 months to 4 years)
  • Child self-regulation(18 months to 4 years)

Study Sites (2)

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