A Digital Health Parent-Training Intervention for Children With Social Communication Delays
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Motor Imitation Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children:
- •aged 14 - 48 months
- •screen positive on the M-CHAT-R/F or already have a diagnosis of autism
- •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
排除标准
- •Children:
- •Have a neurological condition that would preclude engagement in the intervention or testing
研究组 & 干预措施
Treatment as Usual (TAU)
This arm will complete treatment as usual during the 4 months of the study. Specifically, if the family is receiving any intervention, they will continue to receive it. Once the post-treatment study visit is completed, they will be granted access to the intervention being studied (OPT-In-Early)
Treatment (OPT-In-Early) group
The intervention group will receive access to OPT-In-Early. OPT-In-Early is an online 14-module self-directed parent-training program 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.
干预措施: Online Parent Training in Early Behavioral Intervention (OPT-In-Early) (Behavioral)
结局指标
主要结局
Motor Imitation Scale
时间窗: Baseline and 4 months
We will administer a revised Motor Imitation Scale (MIS), a standardized, structured observational measure that assesses a child's ability to imitate familiar and novel motor actions. Children will see 5 actions modeled and then will be prompted to imitate the action using a matching toy. Children are given up to three opportunities to imitate each action. MIS scores range from 0 to 10, with higher scores indicating greater imitation.
Vineland Scales of Adaptive Behavior-3
时间窗: Baseline and 4 months
The Vineland Scales of Adaptive Behavior-3 (Vineland-3) is a standardized parent interview measuring adaptive functioning. It will be administered to all participants at pre- and post-treatment to evaluate change occurring in adaptive behavior across groups. Previous research has documented that this measure has robust psychometric properties, is sensitive to change in response to early intervention, and captures dimensions that are highly valued by stakeholders. Higher scores in the Vineland indicate more advanced adaptive skills.
MacArthur-Bates Communicative Development Inventories (MCDI)
时间窗: Baseline and 4 months
The MacArthur Bates Communication Development Inventory (MCDI) is a parent-report measure that assesses nonverbal communication (gestures) and verbal communication (words). The Words and Gestures form will be used. The MCDI is widely used, standardized, and validated. It is particularly well-suited for large-scale research due to ease of administration, strong psychometric properties, and sensitivity to individual differences in early language development. Higher scores indicate greater communication.
次要结局
- Goal Attainment Scaling(Baseline and 4 months)
- OPT-In-Early Quiz(Baseline and 4 months)
- Treatment Evaluation Inventory Short-Form(4 months)