A Digital Health Parent-Training Intervention for Children With Social Communication Delays

Обзор

Early intervention, during a time of optimal brain plasticity, is critical for autistic children to develop functional skills such as communication and daily living abilities. However, many families face barriers to accessing timely autism-specific services due to delays in autism diagnosis (which is often a prerequisite to autism-specific intervention), long waitlists, high costs, and the necessity to travel far distances to service providers. Self-directed parent-mediated digital health interventions (i.e., programs that parents complete online without provider coaching or feedback) offer a scalable solution to reduce challenges accessing intervention by providing evidence-based strategies that parents can implement without relying on traditional service pathways. The proposed pilot randomized controlled trial (RCT) will test a revised self-directed parent-training program, that teaches parents naturalistic developmental behavioral intervention (NDBI) strategies, which have proven effective for young children with autism. The study will include young children who have already been diagnosed with autism and those who screen positive on an autism screener but have not yet been evaluated, enabling earlier intervention before a formal diagnosis. The study will also explore parents' willingness to engage in the intervention. The specific research aims are: (1) test the preliminary efficacy of the parent-training program vs. treatment as usual (TAU) for 50 children with autism traits and their parents; (2) examine parent engagement in the intervention; and (3) explore predictors of engagement.

Вмешательства

• Поведенческое Online Parent Training in Early Behavioral Intervention (OPT-In-Early)
  OPT-In-Early is an online 14-module self-directed naturalistic developmental behavioral intervention (NDBI) that uses simple text, narration, and interspersed videos to teach parents how to increase their children's social engagement, communication, adaptive behaviors, and reduce challenging behaviors.

Первичные конечные точки

• Motor Imitation Scale [Срок оценки: Baseline and 4 months]
• Vineland Scales of Adaptive Behavior-3 [Срок оценки: Baseline and 4 months]
• MacArthur-Bates Communicative Development Inventories (MCDI) [Срок оценки: Baseline and 4 months]

Вторичные конечные точки (3)

• Goal Attainment Scaling [Срок оценки: Baseline and 4 months]
• OPT-In-Early Quiz [Срок оценки: Baseline and 4 months]
• Treatment Evaluation Inventory Short-Form [Срок оценки: 4 months]

Критерии участия

Критерии включения

• Children:
• aged 14 - 48 months
• screen positive on the M-CHAT-R/F or already have a diagnosis of autism
• Parents:
• Fluent in English
• Agree to complete both study visits and review OPT-In-Early if randomized to the intervention group
• At least 18 years old
• Have access to an internet-connected device

Критерии исключения

• Children:
• Have a neurological condition that would preclude engagement in the intervention or testing

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Florida International University — Miami

Публикации

• Dai YG, Thomas RP, Brennan L, Luu ML, Hughes-Lika J, Reilly M, Moreno P, Obe B, Ahmed KB, Berry LN, Goin-Kochel RP, Helt MS, Barton ML, Dumont-Mathieu T, Robins DL, Fein DA. An initial trial of OPT-In-Early: An online training program for caregivers of autistic children. Autism. 2023 Aug;27(6):1601-1615. doi: 10.1177/13623613221142408. Epub 2022 Dec 15. PMID 36519775
• Dai YG, Thomas RP, Brennan L, Helt MS, Barton ML, Dumont-Mathieu T, Fein DA. Development and Acceptability of a New Program for Caregivers of Children with Autism Spectrum Disorder: Online Parent Training in Early Behavioral Intervention. J Autism Dev Disord. 2021 Nov;51(11):4166-4185. doi: 10.1007/s10803-020-04863-z. Epub 2021 Feb 2. PMID 33527164

Идентификаторы

NCT: NCT07551752 · IRB-25-0140

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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