NCT05635760Completed
Parent-implemented Social Communication Treatment in Autism
A Predict-to-Prescribe Approach to Social Communication Treatment in Chinese Preschool Children With Autism Spectrum Disorder
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 112 (actual)
- First submitted
- 23 Nov 2022
- Start date
- 1 Oct 2022
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Autism
- NCT number
- NCT05635760
What you commit to
- Study type: Interventional
- Participants enrolled: 112
- From 1 Oct 2022 to the primary completion date, 30 Nov 2024
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Parent who has severe psychological or neurological conditions prohibiting them from conducting the intervention program at home (restricted to only the parent in the program)
- Children with any other severe developmental problems beyond autism spectrum disorder
Age
- Mullen Scale of Early Learning non-verbal age at or less than 12 months
Who the study is looking for
- Have a confirmed diagnosis of autism spectrum disorder or was evaluated to have elevated likelihood ("at-risk" or "suspected") by a Clinical Psychologist, Psychiatrist or Pediatrician who recommended continuous surveillance.
- Meet ADOS-2 criteria for autism or autism spectrum.
- Limited spontaneous expressive language, defined as producing two-to-three-word phrases or fewer, i.e., Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) Module 2, Item A1 \> 0.
Age in the registry: 24 months to 60 months · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shenzhen Research Institute, The Chinese University of Hong Kong Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| The Chinese University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.