Clinical trial NCT03945552: Pediatric Parenting Support in Flint
Official title: Universal Strengths-Based Parenting Support in Pediatric Health Care for Families With Very Young Children Following the Flint Water Crisis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Family Research
Keywords: Parenting Practices
Parent-Child Relationships
Child Development
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Michigan State University
name: University of Michigan
name: Northwestern University
First posted: 2019-05-10
Enrollment: 486
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Approximately 600 potential infant/parent dyads screened for inclusion and exclusion criteria.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Parenting compensatory factors (Assets/vulnerabilities): Parenting Stress
timeFrame: 6 months to 4 years
measure: Positive Parenting Activities
timeFrame: 6 months to 4 Years
measure: Parent-child Interaction and relationship
timeFrame: 6 months to 4 Years
measure: Child Expressive and Receptive Language Development
timeFrame: 6 months to 4 Years
measure: Child Social-Emotional Development
timeFrame: 18 months to 4 years
Secondary outcomes:
measure: Parent Self-Efficacy Measured by the Parent Reading Beliefs Inventory (PRBI)
timeFrame: birth to 4 years
measure: Parent Self-Efficacy Measured by the Parenting Self Agency Measure (PSAM)
timeFrame: birth to 4 years
measure: Parent Self-Efficacy Measured by Resiliency (RSA)
timeFrame: birth to 4 years
measure: Parenting compensatory factors: Planning and Organization
timeFrame: 6 months to 4 years
measure: Parenting compensatory factors: Parenting Interaction Skills and Resources
timeFrame: 6 months to 4 years
measure: Parent-child interactions and relationship
timeFrame: 6 months to 4 years
measure: Naturalistic assessment of parent-child interaction
timeFrame: 6 months to 4 years
measure: Negative Parenting Practices
timeFrame: 6 months to 4 years
measure: Child naturalistic language/narrative development
timeFrame: 18 months to 4 years
measure: Child self-regulation
timeFrame: 18 months to 4 years
Other outcomes:
Locations:
city: Flint
country: United States
facility: Hurley Children's Hospital
state: Michigan
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York Langone Medical Center
name: Alan Mendelsohn, MD
role: PRINCIPAL_INVESTIGATOR
References: