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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD096909-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Michigan State University | OTHER |
| University of Michigan | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Care as usual | |
| Video Interaction Project | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video Interaction Project | Behavioral | 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Mendelsohn, MD | New York Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hurley Children's Hospital | Flint | Michigan | 10016 | United States | ||
| New York University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42129365 | Derived | Roby E. Erin Roby: ECI biocommentary. Pediatr Res. 2026 May 13. doi: 10.1038/s41390-026-05093-2. Online ahead of print. | |
| 41833975 | Derived | Roby E, O'Connell LK, Griffin MG, Guevara VA, Aviles AI, Larkins BC, Guyon-Harris KL, Hunter LJ, McLoughlin M, Ndee C, Vaca-Condado L, Canfield CF, Miller EB, Mendelsohn AL, Morris-Perez PA, Shaw DS, Gross RS. Promoting early relational health and resilience in pediatric primary care: a qualitative study. Pediatr Res. 2026 Mar 15:10.1038/s41390-026-04842-7. doi: 10.1038/s41390-026-04842-7. Online ahead of print. |
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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.
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.
Researchers from accredited academic institutions may request access to the study protocol. Permission and access will be granted on an ad hoc basis.
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| Northwestern University |
| OTHER |
Approximately 600 potential infant/parent dyads screened for inclusion and exclusion criteria.
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| 18 months 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 |
| New York |
| New York |
| 10016 |
| United States |
| 40811117 | Derived | Chen Y, Canfield CF, Finegood ED, Gutierrez J, Williams S, O'Connell LK, Mendelsohn A. Family stress model and parenting in infancy: Social support and parenting self-efficacy as resilience factors. J Fam Psychol. 2025 Dec;39(8):1129-1140. doi: 10.1037/fam0001341. Epub 2025 Aug 14. |