跳至主要内容
临床试验/NCT07069413
NCT07069413招募中不适用

Sibwatch: Optimizing Intervention Options for Infants and Toddlers With a High Likelihood of Social Communication Delays and Language Disorder

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2026年4月1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
140
试验地点
2
主要终点
Child Social Communication

研究概览

简要总结

This rigorous randomized controlled trial will evaluate the efficacy and acceptability of a preemptive, telehealth intervention (tele-ImPACT) in a large, representative sample of infant siblings of autistic children, who are known to be at high likelihood of receiving a future diagnosis of autism and/or developmental language disorder (HL-Sibs). If our hypotheses are supported, this innovative and interdisciplinary study will provide empirical support for a novel approach to treatment that is theoretically motivated and developmentally informed, as well as accessible for and acceptable to families, and will lend new insights into the developmental windows in which, mechanisms by which, and subgroups for which the treatment works. Such findings would have strong implications for research, policy, theory, and practice in young children at risk for autism and/or language disorder.

详细描述

Autism is a neurodevelopmental condition that is highly prevalent and that comes at a high cost to affected children and their families. The costs of autism can be attributed, at least in part, to the effects of the condition on children's social communication and language development. Younger siblings of autistic children (HL-Sibs) are highly likely to receive a future diagnosis of autism and/or language disorder themselves. Even those HL-Sibs who are not diagnosed have an increased likelihood of displaying differences in social communication and delays in language development. There is increasing support that preemptive interventions may influence caregivers' use of strategies that scaffold development and translate to effects on social communication and language skills in HL-Sibs. However, prior studies of preemptive interventions have been limited by the inclusion of samples that are rather homogenous, likely reflecting those families who can readily access the medical centers and academic institutions conducting this research. Additionally, past investigations suggest that effects of preemptive interventions may (a) yield only indirect effects on child social communication and language, and (b) vary according to child and caregiver factors, but no previously identified mediators or moderators of preemptive intervention effects have been replicated, and many factors that likely explain or influence differential intervention effects have not yet been explored. Further, the extant literature testing the efficacy of preemptive interventions has administered treatments across a broad range of child ages, and researchers do not yet know precisely when preemptive treatment is most likely to yield favorable effects. Finally, some studies have reported high rates of attrition amongst families assigned to treatment, suggesting that caregivers may not find preemptive interventions to be acceptable. The present study will, thus, evaluate the efficacy of ImPACT, an intervention that is established for use with autistic children and that has amassed some past empirical support as delivered in vivo in HL-Sibs, as administered by telehealth (hereafter referred to as tele-ImPACT) relative to a no-treatment control for effects on caregiver strategy use, proximal child skills, and distal child social communication and language in a large, representative sample in the context of a rigorous randomized clinical trial. Advanced analytic approaches will be employed to test numerous putative moderators and mediators of tele-ImPACT effects, and qualitative approaches will be utilized to assess the acceptability of the candidate treatment amongst caregivers. INNOVATION AND IMPACT: This innovative and interdisciplinary study is expected to (a) provide empirical support for a novel preemptive intervention that is theoretically motivated and developmentally informed, as well as accessible for and acceptable to families affected by autism in the United States, and (b) lend new insights into the developmental windows in which, mechanisms by which, and the subgroups for which this intervention works. Such findings would have strong implications for theory, policy, research, and clinical practice in young children at elevated likelihood for autism and developmental language disorder.

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
Double (Investigator, Outcomes Assessor)

盲法说明

All outcomes assessment ratings will be conducted by an assessor naive to treatment condition. All assessments will be administered by an assessor also naive to treatment condition.

入排标准

年龄范围
6 Months 至 24 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •chronological age between 6-24 months
  • •has at least one older biological sibling diagnosed with autism

排除标准

  • •adverse neurological history
  • •primary sensory deficit (hearing or visual impairment)
  • •pre-term birth (gestation <37 weeks)
  • •pre-existing diagnosis of autism or language delay

研究组 & 干预措施

Business as Usual

No Intervention

Control arm where participants will receive community treatments, as usual.

tele-ImPACT

Experimental

Participants will receive 12 weeks of intervention

干预措施: tele-ImPACT (Behavioral)

结局指标

主要结局

Child Social Communication

时间窗: 9 months

A single z-score average of two scales: VABS socialization standard score (0-100) and ADOS-2 reflected social affect calibrated severity score (inverse coded 1-10). High scores indicate great social communication skills.

Child Receptive Language

时间窗: 9 months

A single z-score average of two scales: MSEL receptive scaled score (20-80) and VABS expressive scaled score (1-24). With higher scores indicating greater receptive language ability.

Child Expressive Language

时间窗: 9 months

A single z-score average of two scales:MSEL expressive scaled score (20-80), VABS expressive scaled score (1-24). With higher scores indicating greater expressive language skills.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lauren Hampton

Associate Professor

University of Texas at Austin

研究点 (2)

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