跳至主要内容
临床试验/NCT05307094
NCT05307094进行中(未招募)不适用

Optimizing Intervention Options for Toddlers With Early Social Communication Delays

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
44
试验地点
2
主要终点
Parent implementation

研究概览

简要总结

Improving social communication outcomes for toddler siblings of children with autism, who are at high risk for multiple language and communication deficits beyond autism, has important public health implications. The proposed study is a pilot sequential multiple random assignment trial of 44 high-risk siblings that examines the feasibility, acceptability, and preliminary effects of an adaptive intervention for social communication. Evaluating effective parent-mediated communication support strategies for toddlers at high-risk supports NIDCD's mission of behavioral research focused on disordered language development and the prevention of health impairments such as communication disorders.

详细描述

High-risk siblings, the infant/toddler siblings of children with autism, are at increased risk for a multitude of language, communication, and academic delays (Ozonoff, Young, Landa, 2015). Although 20% of high-risk siblings will develop autism, those who do not exhibit elevated scores on autism diagnostic assessment, delayed social communication, delayed language, and impairments in social skills even at an early age (Stone, McMahon, Yoder, & Walden, 2007). For high-risk siblings, little is known about when to intervene, how to adapt as concerns develop, and for whom intervention is most beneficial. Thus, the goal of this pilot study is to examine the feasibility, acceptability, and initial effectiveness of an adaptive parent-mediated intervention focused on social communication for high-risk toddlers. We propose an adaptive intervention model that provides intervention options to respond to the ever-changing concern about high-risk toddlers' development. The objective of the proposed study is to examine the acceptability and feasibility of ongoing monitoring and adaptive intervention decisions for this high-risk sibling population. The specific aims include (1) to examine the effects of the adaptive intervention on parent and family outcomes (2) to evaluate and refine the intervention components and study procedures, and (3) to explore the effects of the adaptive intervention on child outcomes. Taken together, these aims provide a foundation to better understand the best adaptive treatment model for high-risk toddlers in response to evolving concern. The proposed pilot study will enroll 44 high-risk sibling toddlers who will be randomly assigned to one of two initial conditions: monthly monitoring or parent-mediated social communication intervention. Following the initial phase of intervention, toddlers will be assessed for social communication development. Those who are rated in the area of concern for social communication development will be re-randomized to receive one of two additional conditions: parent-mediated or parent-plus-clinician social communication intervention. Those who score as low-concern will receive increased monitoring for the remainder of the intervention period. Assessments will occur prior to intervention, following intervention, and 4-months following the end of intervention. The proposed research is significant because it will be the first examination of the impact of an adaptive intervention on parent and child outcomes for high-risk siblings. Understanding the effects of adaptive intervention decisions on parent implementation of social communication strategies and child social communication outcomes is a key step in optimizing interventions for this high-risk sibling group. This initial pilot study will demonstrate the feasibility, acceptability, and initial effects necessary to support a full-scale clinical trial in a future R01 application.

研究设计

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

盲法说明

Outcome assessor is masked to all primary outcome data collection and data coding/ratings.

入排标准

年龄范围
11 Months 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Has a biological sibling diagnosed on the autism spectrum
  • Caregiver is willing to participate in study procedures
  • No known hearing or vision loss
  • Caregiver speaks enough English to participate in the intervention/assessments which are delivered in English.
  • Caregiver uses English for at least half of the day with the toddler.

排除标准

  • Currently receiving early intervention services

结局指标

主要结局

Parent implementation

时间窗: immediately following the intervention period

Parent use of naturalistic strategies with their child using a fidelity of implementation checklist.

Child social communication

时间窗: immediately following the intervention period

Child social communication rate, coded and averaged across a semi-structured parent-child social interactions (including play and snack activties). One score will be derived from the total observation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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