HealthyNCT03945552
Pediatric Parenting Support in Flint
A study testing Video Interaction Project in people with Healthy and Family Research, run by NYU Langone Health at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy, Family Research
- What is being tested?
- Video Interaction Project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 486 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jul 2019to 10 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hurley Children's Hospital
Flint, Michigan, 10016
New York University School of Medicine
New York, New York, 10016
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy, Family Research
- Being tested
- Video Interaction Project
- Keywords
- Parenting Practices, Parent-Child Relationships, Child Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Interaction ProjectBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Video Interaction Project |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 months to 4 years
Secondary outcomes (10)
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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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)
Measured: 6 months to 4 years
Naturalistic assessment of parent-child interaction
LENA Home (adult words, conversational turns)
Measured: 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.
Measured: 6 months to 4 years
Child naturalistic language/narrative development
Laboratory observation of naturalistic assessment of child language/narrative
Measured: 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).
Measured: 18 months to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start23 Jul 2019
- Primary completion10 May 2027 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Approximately 600 potential infant/parent dyads screened for inclusion and exclusion criteria.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Michigan State University, University of Michigan, Northwestern University
- Responsible party
- Sponsor
- Investigators
- Alan Mendelsohn, MD, Principal investigator, New York Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945552
- Sponsor's protocol ID
- 18-01347
- Other IDs
- R01HD096909-01A1
- Status last verified
- Dec 2025
- First submitted
- 8 May 2019
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Roby E. Erin Roby: ECI biocommentary. Pediatr Res. 2026 May 13. doi: 10.1038/s41390-026-05093-2. Online ahead of print.
PubMed 42129365Roby 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.
PubMed 41833975Chen 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.
PubMed 40811117
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Universal Strengths-Based Parenting Support in Pediatric Health Care for Families With Very Young Children Following the Flint Water Crisis
- ClinicalTrials.gov ID
- NCT03945552
- Acronym / sponsor ID
- 18-01347
- Conditions
- Healthy, Family Research
- Keywords
- Parenting Practices, Parent-Child Relationships, Child Development
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 486 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Michigan State University, University of Michigan, Northwestern University
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 10 May 2027 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Approximately 600 potential infant/parent dyads screened for inclusion and exclusion criteria.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Care as usual |
| Video Interaction Project | Experimental | Behavioral: Video Interaction ProjectVIP 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video Interaction ProjectVIP 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. | Behavioural | Video Interaction Project |
Primary outcome
Parenting compensatory factors (Assets/vulnerabilities): Parenting Stress
Time frame: 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.
Positive Parenting Activities
Time frame: 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.
Parent-child Interaction and relationship
Time frame: 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.
Child Expressive and Receptive Language Development
Time frame: 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
Time frame: 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.
10 secondary outcomes
Parent Self-Efficacy Measured by the Parent Reading Beliefs Inventory (PRBI)
Time frame: birth to 4 years
Parent Self-Efficacy Measured by the Parenting Self Agency Measure (PSAM)
Time frame: birth to 4 years
Parent Self-Efficacy Measured by Resiliency (RSA)
Time frame: birth to 4 years
Parenting compensatory factors: Planning and Organization
Time frame: 6 months to 4 years
Parenting compensatory factors: Parenting Interaction Skills and Resources
Time frame: 6 months to 4 years
Parent-child interactions and relationship
Time frame: 6 months to 4 years
Naturalistic assessment of parent-child interaction
Time frame: 6 months to 4 years
Negative Parenting Practices
Time frame: 6 months to 4 years
Child naturalistic language/narrative development
Time frame: 18 months to 4 years
Child self-regulation
Time frame: 18 months to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Derived from this study: PubMed 42129365Roby E. Erin Roby: ECI biocommentary. Pediatr Res. 2026 May 13. doi: 10.1038/s41390-026-05093-2. Online ahead of print.
- Derived from this study: PubMed 41833975Roby 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.
- Derived from this study: PubMed 40811117Chen 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Mendelsohn, MD principal investigator
New York Langone Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Interaction Project in people with Healthy and Family Research, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting compensatory factors (Assets/vulnerabilities): Parenting Stress (time frame: 6 months to 4 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03945552, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.