跳至主要内容
临床试验/NCT07500363
NCT07500363招募中不适用

Improving Caregiver Engagement in Early Interventions for Autistic Children Using a Mobile Health Approach

University of California, Davis1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2026年3月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
28
试验地点
1
主要终点
Parent Participatory Engagement Measure

研究概览

简要总结

The goal of this study is to test the effectiveness of the FANS-EI program in supporting caregiver engagement in caregiver-mediated early interventions for young children with autism. This study also examines caregiver-perceived social support and self-efficacy and FANS-EI implementation outcomes (feasibility, acceptability, appropriateness).

详细描述

Caregiver involvement in early intervention (EI) goal setting and intervention delivery aligns with Part C of the Individuals with Disabilities Education Act (IDEA) guidelines. Active participation from caregivers significantly influences intervention adherence and ultimately affects child outcomes. When caregivers struggle with obtaining a diagnosis and early intervention services, low caregiver engagement can further exacerbate these challenges. In fact, the attrition rate for parent-mediated early interventions for autism ranges from 35% to 62%. Therefore, it is crucial to develop effective strategies for supporting caregiver engagement in autism early intervention. This study aims to examine the effectiveness of a social-support enhancement program, called Family/Friend Network Support for Early Intervention (FANS-EI), designed to improve caregiver engagement in community-based autism EI. This program has been adapted in collaboration with community partners from a text-based program that has successfully increased engagement and patient outcomes in diabetes treatment. Families of toddlers diagnosed with autism or a high likelihood of autism, will either receive EI as usual or FANS-EI plus EI. FANS-EI utilizes a strengths-based approach, leveraging existing family and friend support networks. Supporters, alongside caregivers, will receive information about autism or social communication development, along with text messages from the research team. These messages are designed to foster interactions between supporters and caregivers, providing emotional, informational, and educational support. The project will examine caregiver-perceived social support, self-efficacy, and implementation outcomes. Ultimately, the goal is to enhance caregiver engagement, maximizing the benefits of early interventions for both caregivers and their autistic children. This project would help further the knowledge of improving caregiver engagement in community-partnered research while addressing the persistent challenges in service utilization and child outcomes.

研究设计

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

入排标准

年龄范围
12 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Providers' eligibility criteria
  • currently providing early intervention services, including a caregiver-coaching component
  • having at least 1 child in the autism service classification on their caseload.
  • Caregiver/Child Dyads eligibility criteria
  • child is 12-60 months of age at the time of enrollment
  • child has a diagnosis or high likelihood of autism
  • a family/friend supporter of the caregiver is willing to be part of the study
  • caregivers and supporters speak English

排除标准

  • 未提供

研究组 & 干预措施

Treatment as usual

Active Comparator

Families receive early intervention as usual

干预措施: Early Intervention (Behavioral)

FANS-EI

Experimental

FANS-EI supporters and caregivers will receive text messages from the research team three times a week. The messages to supporters mirror the caregiver messages and will include educational/motivational messages. Supporter will receive asynchronized general educational materials about autism (including characteristics of autism, understanding child's behaviors, etc.). Supporters will have the option, but will not be required, to attend EI sessions with the family if the family agrees.

干预措施: FANS-EI (Behavioral)

结局指标

主要结局

Parent Participatory Engagement Measure

时间窗: Weekly for 6 months

The 5-item Parent Participatory Engagement Measure (PPEM) examines caregiver comfort with, engagement and participation in the intervention.

次要结局

  • Caregiver Buy-In to EI(baseline, 6 months)
  • Parenting Sense of Competence Scale(Baseline, 6 months)
  • Social Support Index(Baseline, 6 months)
  • Acceptability of Intervention Measure(6 months)
  • Intervention Appropriateness Measure(6 months)
  • Feasibility of Intervention Measure(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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