Pediatric Parenting Support in Flint

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03945552
• Other study ID #: 18-01347
• Secondary ID: R01HD096909-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 23, 2019
• Est. completion date: February 28, 2025

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 486
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Family Research
• Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	Hurley Children's Hospital	Flint	Michigan
United States	New York University School of Medicine	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
NYU Langone Health	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Michigan State University, Northwestern University, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parenting compensatory factors (Assets/vulnerabilities): Parenting Stress	Parenting stress measured by Parent Survey (PS) with the Parenting Stress Index (PSI; a= .82) short form parental distress subscale, range 12-60, higher scores worse.	6 months to 4 years
Primary	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
Primary	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
Primary	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
Primary	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	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 (a=.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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Naturalistic assessment of parent-child interaction	LENA Home (adult words, conversational turns)	6 months to 4 years
Secondary	Negative Parenting Practices	Socolar Discipline Survey (a= .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
Secondary	Child naturalistic language/narrative development	Laboratory observation of naturalistic assessment of child language/narrative	18 months to 4 years
Secondary	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