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ACTIVE NOT RECRUITING
NCT05635760
NA

Parent-implemented Social Communication Treatment in Autism

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

Summary

An accumulation of research evidence has pointed to parent-implemented communication intervention as effective in reducing the severity of social communication deficits in autistic preschoolers. Despite even high-quality evidence, real-world translation to clinical practice remains challenging, especially for children from lower-income families, for two reasons. First, the intervention outcome is highly variable despite study-level efficacy data, most likely due to unique child and parent factors that make intervention response uneven across individual children. Second, the cost of intervention with the largest effect sizes remains high due to its one-on-one format. With the overarching goal to reduce cost and to increase intervention effectiveness at the individual-child level, this project will conduct a randomized controlled trial (RCT) to compare the effectiveness of two options for intervention to address two specific objectives. The investigators will first ascertain whether parent-implemented communication intervention taught by a speech therapist in a Group format (up to 8 families learning together) is more effective than intervention learnt by the parents themselves (learning the same materials without the guidance of a therapist) at the study level. The investigators will then evaluate what combinations of parent and child behavioral factors determine which format of intervention is likely to be more effective at the individual-child level. It is likely that not all families require the more costly Group format of intervention. Machine learning analytics with cross-validation will be used in constructing predictive models of intervention response, which will increase the likelihood of these models being generalizable to new patients. This study will be among the first examples of fulfilling the promise of Precision Medicine in providing guidance to patients and families with developmental disorders not about whether to receive intervention but which option for intervention to receive in the context of multiple options. This predict-to prescribe approach of autism intervention will likely lead to a paradigm shift in clinical practice and ultimately result in lowering the overall cost and increasing the effectiveness of intervention for autistic children as individuals.

Official title: A Predict-to-Prescribe Approach to Social Communication Treatment in Chinese Preschool Children With Autism Spectrum Disorder

Key Details

Gender

All

Age Range

24 Months - 60 Months

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2022-10-01

Completion Date

2025-12-30

Last Updated

2025-07-01

Healthy Volunteers

No

Interventions

BEHAVIORAL

Group-based Parent-implemented Social Communication Training

The intervention will be taught by a speech therapist online (approximately 25 hours distributed over 6 months), with up to 8 parents in a group.

BEHAVIORAL

Self-learning-based Parent-implemented Social Communication Training

Self-learning families will learn the same materials without the guidance of a therapist.

Locations (2)

Shenzhen Research Institute, The Chinese University of Hong Kong

Shenzhen, Guangdong, China

The Chinese University of Hong Kong

Hong Kong, Shatin, Hong Kong