跳至主要内容
临床试验/NCT06347666
NCT06347666终止不适用

Equity-focused Implementation of Caregiver Coaching for Unhoused Children At-risk for Developmental Delay

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2024年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
9
试验地点
2
主要终点
Parenting Sense of Competence Scale

研究概览

简要总结

Among young children, homelessness is an independent predictor of child developmental delay and disability, and children experiencing homelessness (CEH) are 2-4x more likely to demonstrate developmental delays compared to housed children. The purpose of this project is to evaluate an evidence-based model of caregiver coaching for CEH that screen positive for developmental delay. The investigators will also evaluate the societal costs of the program, its preliminary efficacy, and the acceptability among caregivers and shelter staff.

详细描述

Over 2.5 million children experience homelessness (CEH) in a given year and housing intersects with inequities due to race and disability. Among young children, homelessness is an independent predictor of child developmental delay and disability, and CEH are 2-4x more likely to demonstrate developmental delays compared to housed children. Caregiver coaching is an evidence-based and effective behavioral therapy method to support child development and has been recommended by the American Academy of Pediatrics for adoption across all early intervention (EI) systems. EI is mandated by states under the Individuals with Disabilities Education Act (IDEA) Part C and provides behavioral therapy for all children ages 0-3 years that show developmental delay. Within EI, caregiver coaching is delivered is delivered in families' homes, and therefore has limited evaluation of implementation in shelters. In ongoing pilot work, in collaboration with shelter-based primary care, 70% of CEH screened positive for developmental delay, yet no child received caregiver coaching through EI. Therefore, the objective of this proposal is to use a Type II Hybrid Trial to investigate how implementation strategies influence uptake of shelter-based caregiver coaching and subsequent child outcomes. The proposed study will use implementation research as a guide to evaluate our team's implementation of caregiver coaching from an equity lens among a population that consistently lacks access to evidence-based interventions to improve children's developmental trajectories. Specifically, the investigators will 1) Evaluate implementation of a 12-week shelter-based caregiver coaching intervention on caregiver attendance and fidelity (i.e., adherence) among CEH with delay ages compared to statewide equity metrics; 2) Evaluate the societal costs of implementing a 12-week shelter-based caregiver coaching intervention; 3) Investigate facilitators and barriers related to attendance and fidelity of a 12-week coaching intervention among caregivers of CEH and shelter staff; 4) Explore the efficacy of the 12-week coaching intervention on caregiver and child outcomes. While disparities in access to evidence-based developmental care for CEH is documented, the investigators will identify how strategies that promote equity in access result in caregiver uptake and costs. By evaluating stakeholder feedback of an evidence-based intervention not yet tested in shelters, the investigators can integrate changes to the model for future trials. The impact will be on prioritizing ways to promote uptake of tailored developmental interventions for children most in need, ultimately contributing to evidence to share with families, shelters, and policymakers to create sustainable models of care.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children must be unhoused or experience housing instability and screen positive for developmental delay

排除标准

  • Children are excluded if they are receiving more than 1 hour/week of early intervention

结局指标

主要结局

Parenting Sense of Competence Scale

时间窗: baseline and post-12 week intervention

Self-report of satisfaction and efficacy associated with parenting. Higher scores mean that a respondent has higher parenting sense of competence. Scores range from 6-102.

Parenting Stress Scale

时间窗: baseline and post-12 week intervention

Self-report of stressors associated with parenting. Higher scores mean higher parenting stress and scores range from 18-90.

次要结局

  • Mullen Scales of Early Learning(baseline and post-12 week intervention)
  • Maternal Behavior Responsivity Scale(baseline and post-12 week intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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