Pediatric Parenting Support in Flint

Not Applicable

Active, not recruiting

• Conditions: Healthy; Family Research
• Interventions: Behavioral: Video Interaction Project

• Registration Number: NCT03945552
• Lead Sponsor: NYU Langone Health

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-05-08
• Study First Submitted QC: 2019-05-08
• Study First Posted: 2019-05-10
• Study Start: 2019-07-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-22
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 486

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video Interaction Project	Video Interaction Project	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 Outcome Measures

Name	Time	Method
Positive Parenting Activities	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	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	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	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	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 Outcome Measures

Name	Time	Method
Naturalistic assessment of parent-child interaction	6 months to 4 years	LENA Home (adult words, conversational turns)
Parenting compensatory factors: Planning and Organization	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).
Negative Parenting Practices	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.
Parent Self-Efficacy Measured by Resiliency (RSA)	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.
Parent-child interactions and relationship	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)
Child naturalistic language/narrative development	18 months to 4 years	Laboratory observation of naturalistic assessment of child language/narrative
Parent Self-Efficacy Measured by the Parent Reading Beliefs Inventory (PRBI)	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.
Parent Self-Efficacy Measured by the Parenting Self Agency Measure (PSAM)	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
Parenting compensatory factors: Parenting Interaction Skills and Resources	6 months to 4 years	Play coded video for VIP-promoted skills measured using VIP observation checklist
Child self-regulation	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).

Trial Locations

Locations (2)

Hurley Children's Hospital; 🇺🇸 Flint, Michigan, United States

New York University School of Medicine; 🇺🇸 New York, New York, United States