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Pediatric Parenting Support in Flint

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ClinicalTrials.gov Identifier: NCT03945552
Recruitment Status : Not yet recruiting
First Posted : May 10, 2019
Last Update Posted : May 29, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Michigan State University
University of Michigan
Northwestern University
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE May 8, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date May 29, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date February 28, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • Parent Self Efficacy measured by Parent Survey (PS) [ Time Frame: 3 Years ]
    Self-efficacy: Parent Reading Beliefs (Teaching Efficacy subscale; α=.73)
  • Planning and Organization measured by Parent Survey (PS) [ Time Frame: 3 Years ]
    Feeding, sleep, media routines (PI Mendelsohn; kappa 0.91)
  • Extended family support measured by Parent Survey (PS) [ Time Frame: 3 Years ]
    Feeding, sleep, media routines (PI Mendelsohn; kappa 0.91)
  • Observation of parent and child Interaction skills and resources [ Time Frame: 3 Years ]
    Parent-child play coded for VIP-promoted skills (using VIP observation checklist)
  • Parenting Stress measured by Parent Survey (PS) [ Time Frame: 3 Years ]
    Parenting anxiety/depression: Parenting Stress Index(PSI; α=.82) Parental Distress
  • Positive practices measured by Parent Survey (PS) [ Time Frame: 3 Years ]
    StimQ: Reading, teaching, responsivity; (PI Mendelsohn; α=.88; r w/HOME .5)
  • Negative practices measured by Parent Survey (PS) [ Time Frame: 3 Years ]
    StimQ: Reading, teaching, responsivity; (PI Mendelsohn; α=.88; r w/HOME .5)
  • Observation of parent-child interactions [ Time Frame: 3 Years ]
    Video-recorded (Lab) semi-structured interactions with real time coding (PICCOLO216, ACIRI217) + subsequent global coding (C-CARES); LENA (Home; subset of families 6, 18mos): adult words, conversational turns
  • Relationship Quality Measured by Harsh Disciple Survey [ Time Frame: 3 Years ]
Change History Complete list of historical versions of study NCT03945552 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • Parent Self-Efficacy Measured by the Parent Reading Beliefs Inventory (PRBI) [ Time Frame: birth to 4 years ]
    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.
  • Parent Self-Efficacy Measured by the Parenting Self Agency Measure (PSAM) [ Time Frame: birth to 4 years ]
    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
  • Parent Self-Efficacy Measured by Resiliency (RSA) [ Time Frame: birth to 4 years ]
    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.
  • Parenting compensatory factors: Planning and Organization [ Time Frame: 6 months to 4 years ]
    Feeding, sleeping, media routines and screen time measured by parent survey (PS) using an internal survey (PI Mendelsohn; kappa 0.91).
  • Parenting compensatory factors: Parenting Interaction Skills and Resources [ Time Frame: 6 months to 4 years ]
    Play coded video for VIP-promoted skills measured using VIP observation checklist
  • Parent-child interactions and relationship [ Time Frame: 6 months to 4 years ]
    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)
  • Naturalistic assessment of parent-child interaction [ Time Frame: 6 months to 4 years ]
    LENA Home (adult words, conversational turns)
  • Negative Parenting Practices [ Time Frame: 6 months to 4 years ]
    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.
  • Child naturalistic language/narrative development [ Time Frame: 18 months to 4 years ]
    Laboratory observation of naturalistic assessment of child language/narrative
  • Child self-regulation [ Time Frame: 18 months to 4 years ]
    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).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pediatric Parenting Support in Flint
Official Title  ICMJE Universal Strengths-Based Parenting Support in Pediatric Health Care for Families With Very Young Children Following the Flint Water Crisis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Approximately 600 potential infant/parent dyads screened for inclusion and exclusion criteria.
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Healthy
  • Family Research
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Video Interaction Project
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2019)
500
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2019)
600
Estimated Study Completion Date  ICMJE February 28, 2024
Estimated Primary Completion Date February 28, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infant is receiving pediatric care at Hurley Children's Clinic
  • Caregiver can be contacted (has a working phone)
  • Caregiver was Flint resident from emergence of crisis (fall of 2014) to time of - enrollment
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 3 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Caroline Raak 6465014651 Caroline.Raak@nyulangone.org
Contact: Caitlin Canfield 212 562 2522 Caitlin.Canfield@nyulangone.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03945552
Other Study ID Numbers  ICMJE 18-01347
R01HD096909-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
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.
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.
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Michigan State University
  • University of Michigan
  • Northwestern University
Investigators  ICMJE
Principal Investigator: Alan Mendelsohn, MD New York Langone Medical Center
PRS Account NYU Langone Health
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP