AutismNCT05635760
Parent-implemented Social Communication Treatment in Autism
A study testing Group-based Parent-implemented Social Communication Training and Self-learning-based Parent-implemented Social Communication Training in people with Autism and Social Communication, run by Chinese University of Hong Kong at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 60 months
- Conditions the study is for
- Autism, Social Communication, Speech Therapy
- What is being tested?
- Group-based Parent-implemented Social Communication Training and Self-learning-based Parent-implemented Social Communication Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2022to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Mullen Scale of Early Learning non-verbal age at or less than 12 months
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
China1 site
Shenzhen Research Institute, The Chinese University of Hong Kong
Shenzhen, Guangdong, 518057
About this study
Official title: A Predict-to-Prescribe Approach to Social Communication Treatment in Chinese Preschool Children With Autism Spectrum Disorder
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.
Read the detailed description
For parents of autistic children, the primary concern is to minimize the impact of the condition, likely through evidence-based intervention. The secondary concern is whether any intervention prescribed is affordable and the logistics of completion feasible. This project will obtain evidence for autism intervention options that have different costs and intervention delivery formats (group vs. self-study) to evaluate whether a more costly option is more effective at the study level. The investigators will then develop a predict to-prescribe approach that informs parents which intervention option would likely be most cost-effective in light of each family's unique characteristics (i.e., effectiveness at the individual-child level). [We use the term "parents" to mean caregivers throughout this protocol.]
Autism affects 14 per 10,000 (0.14%) children in Hong Kong and 39.23 per 10,000 in Mainland China. Social communication is a challenging domain in autism, and about 29% of autistic preschoolers have severe verbal deficits. Intervention through pharmaceutical means remains elusive, leaving behavioral interventions the most realistic and immediate avenue of intervention. This project will focus on enhancing the cost-effectiveness of behavioral intervention that targets language and communication. The investigators will do so in the context of precision medicine, in which the investigators aim to identify the most cost effective intervention for the individual autistic child.
AIM OF STUDY:
Objective 1: 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.
Objective 2: The investigators will examine pre-intervention child and parent variables simultaneously and construct predictive models of response to the two intervention options (group, more costly vs. self-study, less costly) at the individual-child level.
- Being tested
- Group-based Parent-implemented Social Communication Training, Self-learning-based Parent-implemented Social Communication Training
- Keywords
- Autism Spectrum Disorder, Parent-implemented Intervention, Social Communication
- Medical subject headings
- Autistic Disorder, Communication, Communication Disorders, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based Parent-implemented Social Communication TrainingBehavioural
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.
Self-learning-based Parent-implemented Social Communication TrainingBehavioural
Self-learning families will learn the same materials without the guidance of a therapist.
| Study group | Role | What they receive |
|---|---|---|
| Group-based Parent-implemented Social Communication Training | Experimental | Eight parents learning in a group format and will be taught by a speech therapist online. Receives: Behavioral: Group-based Parent-implemented Social Communication Training |
| Self-learning-based Parent-implemented Social Communication Training | Active comparator | Parents will learn the same materials without the guidance of a therapist. Receives: Behavioral: Self-learning-based Parent-implemented Social Communication Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism severity change between baseline and 12 months
Comparing the pre- and post-intervention autism severity measured by comparison scores of Autism Diagnostic Observation Schedule™, Second Edition (ADOS-2) between groups.
The ADOS-2 CSS ranges from 0 to 10; the higher the scores, the more severe the autism symptoms.
Measured: Baseline and 12 months after baseline
Social skill changes
Comparing the pre- and post-intervention social skills measured by the Social Affect score of Autism Diagnostic Observation Schedule™, Second Edition (ADOS-2), Social Communication Scale (SCS), and Vineland-3 between groups.
Measured: Baseline, immediately post-intervention (at 6 months), and 12 months after baseline
Expressive langauge changes
Comparing the pre- and post-intervention expressive language skills measured by the Mullen Scales of Early Learning (MSEL), the MLU transcribed from the Social Communication Scale (SCS), and Vineland-3 between groups.
Measured: Baseline, immediately post-intervention (at 6 months), and 12 months after baseline
Receptive language changes
Comparing the pre- and post-intervention receptive language skills measured by the Mullen Scales of Early Learning (MSEL), and Vineland-3 between groups.
Measured: Baseline, immediately post-intervention (at 6 months), and 12 months after baseline
Secondary outcomes (3)
Parental stress changes
Comparing the pre- and post-intervention parental stress measured by the the Parental Stress Scale (PSS) between groups.
Measured: Baseline and immediately post-intervention (at 6 months)
Parental competence changes
Comparing the pre- and post-intervention parental competence including self-efficacy and satisfaction measured by the Parenting Sense of Competence (PSOC) between groups.
Measured: Baseline and immediately post-intervention (at 6 months)
Parental strategy use changes
Comparing the pre- and post-intervention parental strategy use including promoting engagement, encouraging communication, and direct teaching coded from the Social Communication Scale (SCS) between groups.
Measured: Baseline, immediately post-intervention (at 6 months), and 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start1 Oct 2022
- Primary completion30 Nov 2024
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick C. M. Wong, Chinese University of Hong Kong
- Investigators
- Patrick CM Wong, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635760
- Sponsor's protocol ID
- CRFASD-SZ-22
- Status last verified
- Oct 2026
- First submitted
- 23 Nov 2022
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang L, Shi Y, So HC, Hirai HW, Qi X, To CKS, Ng FF, Wong PCM. Who benefits most? A randomized controlled trial for Parent-implemented social communication intervention for chinese-speaking autistic preschoolers. Mol Autism. 2026 Jul 2;17(1):29. doi: 10.1186/s13229-026-00725-0.
PubMed 42393738
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Predict-to-Prescribe Approach to Social Communication Treatment in Chinese Preschool Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05635760
- Acronym / sponsor ID
- CRFASD-SZ-22
- Keywords
- Autism Spectrum Disorder, Parent-implemented Intervention, Social Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For parents of autistic children, the primary concern is to minimize the impact of the condition, likely through evidence-based intervention. The secondary concern is whether any intervention prescribed is affordable and the logistics of completion feasible. This project will obtain evidence for autism intervention options that have different costs and intervention delivery formats (group vs. self-study) to evaluate whether a more costly option is more effective at the study level. The investigators will then develop a predict to-prescribe approach that informs parents which intervention option would likely be most cost-effective in light of each family's unique characteristics (i.e., effectiveness at the individual-child level). [We use the term "parents" to mean caregivers throughout this protocol.]
Autism affects 14 per 10,000 (0.14%) children in Hong Kong and 39.23 per 10,000 in Mainland China. Social communication is a challenging domain in autism, and about 29% of autistic preschoolers have severe verbal deficits. Intervention through pharmaceutical means remains elusive, leaving behavioral interventions the most realistic and immediate avenue of intervention. This project will focus on enhancing the cost-effectiveness of behavioral intervention that targets language and communication. The investigators will do so in the context of precision medicine, in which the investigators aim to identify the most cost effective intervention for the individual autistic child.
AIM OF STUDY:
Objective 1: 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.
Objective 2: The investigators will examine pre-intervention child and parent variables simultaneously and construct predictive models of response to the two intervention options (group, more costly vs. self-study, less costly) at the individual-child level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-based Parent-implemented Social Communication Training | Experimental | Behavioral: Group-based Parent-implemented Social Communication TrainingEight parents learning in a group format and will be taught by a speech therapist online. |
| Self-learning-based Parent-implemented Social Communication Training | Active comparator | Behavioral: Self-learning-based Parent-implemented Social Communication TrainingParents will learn the same materials without the guidance of a therapist. |
Who may qualify
- Ages
- 24 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Mullen Scale of Early Learning non-verbal age at or less than 12 months
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group-based Parent-implemented Social Communication TrainingThe intervention will be taught by a speech therapist online (approximately 25 hours distributed over 6 months), with up to 8 parents in a group. | Behavioural | Group-based Parent-implemented Social Communication Training |
| Self-learning-based Parent-implemented Social Communication TrainingSelf-learning families will learn the same materials without the guidance of a therapist. | Behavioural | Self-learning-based Parent-implemented Social Communication Training |
Primary outcome
Autism severity change between baseline and 12 months
Time frame: Baseline and 12 months after baseline
Comparing the pre- and post-intervention autism severity measured by comparison scores of Autism Diagnostic Observation Schedule™, Second Edition (ADOS-2) between groups. The ADOS-2 CSS ranges from 0 to 10; the higher the scores, the more severe the autism symptoms.
Social skill changes
Time frame: Baseline, immediately post-intervention (at 6 months), and 12 months after baseline
Comparing the pre- and post-intervention social skills measured by the Social Affect score of Autism Diagnostic Observation Schedule™, Second Edition (ADOS-2), Social Communication Scale (SCS), and Vineland-3 between groups.
Expressive langauge changes
Time frame: Baseline, immediately post-intervention (at 6 months), and 12 months after baseline
Comparing the pre- and post-intervention expressive language skills measured by the Mullen Scales of Early Learning (MSEL), the MLU transcribed from the Social Communication Scale (SCS), and Vineland-3 between groups.
Receptive language changes
Time frame: Baseline, immediately post-intervention (at 6 months), and 12 months after baseline
Comparing the pre- and post-intervention receptive language skills measured by the Mullen Scales of Early Learning (MSEL), and Vineland-3 between groups.
3 secondary outcomes
Parental stress changes
Time frame: Baseline and immediately post-intervention (at 6 months)
Parental competence changes
Time frame: Baseline and immediately post-intervention (at 6 months)
Parental strategy use changes
Time frame: Baseline, immediately post-intervention (at 6 months), and 12 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Derived from this study: PubMed 42393738Wang L, Shi Y, So HC, Hirai HW, Qi X, To CKS, Ng FF, Wong PCM. Who benefits most? A randomized controlled trial for Parent-implemented social communication intervention for chinese-speaking autistic preschoolers. Mol Autism. 2026 Jul 2;17(1):29. doi: 10.1186/s13229-026-00725-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick CM Wong, PhD principal investigator
Chinese University of Hong Kong
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based Parent-implemented Social Communication Training and Self-learning-based Parent-implemented Social Communication Training in people with Autism and Social Communication, run by Chinese University of Hong Kong at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autism severity change between baseline and 12 months (time frame: Baseline and 12 months after baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05635760, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.