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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy; Family Research
• Intervention / Treatment: Behavioral: Video Interaction Project

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.

• Study Type: Interventional
• Enrollment (Estimated): 486
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Flint, Michigan, United States, 10016
      • Hurley Children's Hospital
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Care as usual
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Self-Efficacy Measured by the Parent Reading Beliefs Inventory (PRBI)	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.	birth to 4 years
Parent Self-Efficacy Measured by the Parenting Self Agency Measure (PSAM)	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	birth to 4 years
Parent Self-Efficacy Measured by Resiliency (RSA)	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.	birth to 4 years
Parenting compensatory factors: Planning and Organization	Feeding, sleeping, media routines and screen time measured by parent survey (PS) using an internal survey (PI Mendelsohn; kappa 0.91).	6 months to 4 years
Parenting compensatory factors: Parenting Interaction Skills and Resources	Play coded video for VIP-promoted skills measured using VIP observation checklist	6 months to 4 years
Parent-child interactions and relationship	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)	6 months to 4 years
Naturalistic assessment of parent-child interaction	LENA Home (adult words, conversational turns)	6 months to 4 years
Negative Parenting Practices	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.	6 months to 4 years
Child naturalistic language/narrative development	Laboratory observation of naturalistic assessment of child language/narrative	18 months to 4 years
Child self-regulation	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).	18 months to 4 years

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Northwestern University; University of Michigan; Michigan State University
• Investigators: Principal Investigator: Alan Mendelsohn, MD, New York Langone Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2019
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 10, 2019

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Child Development; Parenting Practices; Parent-Child Relationships
• Other Study ID Numbers: 18-01347; R01HD096909-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No