跳至主要内容
临床试验/NCT03945552
NCT03945552进行中(未招募)不适用

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

NYU Langone Health3 个研究点 分布在 1 个国家目标入组 486 人开始时间: 2019年7月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
486
试验地点
3
主要终点
Positive Parenting Activities

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Video Interaction Project (Behavioral)

结局指标

主要结局

Positive Parenting Activities

时间窗: 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.

Child Expressive and Receptive Language Development

时间窗: 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

时间窗: 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.

Parenting compensatory factors (Assets/vulnerabilities): Parenting Stress

时间窗: 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.

Parent-child Interaction and relationship

时间窗: 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.

次要结局

  • Naturalistic assessment of parent-child interaction(6 months to 4 years)
  • Parenting compensatory factors: Planning and Organization(6 months to 4 years)
  • Negative Parenting Practices(6 months to 4 years)
  • Parent Self-Efficacy Measured by Resiliency (RSA)(birth to 4 years)
  • Parent-child interactions and relationship(6 months to 4 years)
  • Child naturalistic language/narrative development(18 months to 4 years)
  • Parent Self-Efficacy Measured by the Parent Reading Beliefs Inventory (PRBI)(birth to 4 years)
  • Parent Self-Efficacy Measured by the Parenting Self Agency Measure (PSAM)(birth to 4 years)
  • Parenting compensatory factors: Parenting Interaction Skills and Resources(6 months to 4 years)
  • Child self-regulation(18 months to 4 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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