Autism Spectrum DisorderNCT05455411
Parent-implemented Social Communication Treatment in Preschool Children With Autism Spectrum Disorder
A study testing Group-based Parent-implemented Training and Individual-based Parent-implemented Training in people with Autism Spectrum Disorder and Autism, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
An accumulation of research evidence has pointed to parent-implemented communication treatment as effective in reducing the severity of social communication deficits in preschool children with ASD. Read more about this study
- Who is it for?
- Ages 24 to 60 months
- Conditions the study is for
- Autism Spectrum Disorder, Autism, Social Communication
- What is being tested?
- Group-based Parent-implemented Training and Individual-based Parent-implemented Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Jul 2022to 30 Jun 2026
- 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.
- ADOS-2 score in the spectrum range (for Modules 1 \& 2) or mild-to-moderate concern range (for Toddler Module)
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 treatment 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 1 country.
Hong Kong2 sites
The Chinese University of Hong Kong
Shatin
Castle Peak Hospital
Tuenmen
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 treatment as effective in reducing the severity of social communication deficits in preschool children with ASD. 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 treatment outcome is highly variable despite study-level efficacy data, most likely due to unique child and parent factors that make treatment 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 treatment 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 treatment taught by a speech therapist in an Individual (one-on-one) format is more effective than treatment taught in a Group format (up to 8 families learning together) at the study level. The Individual format is at least 4 times more expensive than the Group format; its relative treatment effect must be empirically ascertained to justify its cost. The investigators will then evaluate what combinations of parent and child behavioral and neural 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 Individual format of intervention. Machine-learning analytics with cross-validation will be used in constructing predictive models of treatment 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 ASD 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 children with ASD as individuals.
Read the detailed description
BACKGROUND:
For parents of children with Autism Spectrum Disorder (ASD), the primary concern is to minimize the impact of the disorder, 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 ASD intervention options that have different costs and intervention delivery formats (individual vs. group) 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.]
ASD affects 14 per 10,000 (0.14%) children in Hong Kong and 39.23 per 10,000 in Mainland China. Social communication is a deficit domain of ASD, and about 29% of preschoolers with ASD have severe verbal deficits. Intervention through pharmaceutical means remains elusive, leaving behavioral interventions the most realistic and immediate avenue of treatment. 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 child with ASD.
AIM OF STUDY:
Objective 1: The investigators will first ascertain whether parent-implemented communication treatment taught by a speech therapist in an Individual (one-on-one) format is more effective than treatment taught in a Group format (up to 8 families learning together) at the study level.
Objective 2: The investigators will examine pre-treatment child and parent variables simultaneously and construct predictive models of response to the two treatment options (group, less costly vs. individual, more costly) at the individual-child level. Both neural and non-neural variables will be examined to increase the precision of prediction.
HYPOTHESIS:
By the investigators' estimate, even after the number of contact hours is controlled, the group format is at least 4 times cheaper than the one-on-one format. Individual sessions allow for individualization, clearer explanation and modeling of the strategies, as well as some clinician-to-child stimulations that cannot be achieved by lectures. Though it may seem obvious that this individual format must produce better results, it is possible that the group format may be more effective due to better social support offered by peers.
- Being tested
- Group-based Parent-implemented Training, Individual-based Parent-implemented Training
- Keywords
- Autism Spectrum Disorder, Parent-implemented Intervention, Social Communication
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Communication, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based Parent-implemented TrainingBehavioural
A group-based social communication training for parents of preschoolers with autism spectrum disorder will be taught by a speech therapist online (approximately 25 hours distributed over 6 months), with up to 8 parents in a group.
Individual-based Parent-implemented TrainingBehavioural
An individual-based social communication training for parents of preschoolers with autism spectrum disorder will be taught by a speech therapist online in a one-on-one format (approximately 25 hours distributed over 6 months).
| Study group | Role | What they receive |
|---|---|---|
| Group-based Parent-implemented Social Communication Training | Experimental | A group-based parent-implemented social communication treatment program for up to 8 parents of children with autism spectrum disorder Receives: Behavioral: Group-based Parent-implemented Training |
| Individual-based Parent-implemented Social Communication Training | Active comparator | An individual-based parent-implemented social communication treatment program for a parent of a child with autism spectrum disorder Receives: Behavioral: Individual-based Parent-implemented Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Social Affect at 12 months
Comparing the pre- and post-treatment social affect measured by the Social Affect subscore of Autism Diagnostic Observation Schedule™, Second Edition (ADOS-2) between groups.
The Social Affect subscore of ADOS-2 ranges from 0 to 20; the higher ADOS-2 scores mean a worse outcome.
Measured: Baseline and at 12 months after the beginning of treatment
Change from Baseline Receptive Language at 12 months
Comparing the pre- and post-treatment receptive language measured by the Receptive Language domain of Mullen Scales of Early Learning (MSEL) between groups.
The MSEL score T-score ranges from 20 to 80; the higher MSEL scores mean a better outcome.
Measured: Baseline and at 12 months after the beginning of treatment
Change from Baseline Expressive Language at 12 months
Comparing the pre- and post-treatment expressive language measured by the Expressive Language domain of Mullen Scales of Early Learning (MSEL) between groups.
The MSEL score T-score ranges from 20 to 80; the higher MSEL scores mean a better outcome.
Measured: Baseline and at 12 months after the beginning of treatment
Secondary outcomes (7)
Change from Baseline Number of Parent-child Turn-taking at 6 months and 12 months
Comparing the pre- and post-treatment number of parent-child turn-taking between groups.
A parent-child interaction video will be taken; the number of turn-taking will be counted. The greater number of the mentioned language and communication features mean a better outcome.
Measured: Baseline, at 6 months and at 12 months after the beginning of treatment
Change from Baseline Mean Length of Utterance at 6 months and 12 months
Comparing the pre- and post-treatment mean length of utterance between groups.
A parent-child interaction video will be taken; speech of children will be transcribed. The length of utterance will be assessed and the mean length of utterance will be calculated. The longer mean length of utterance mean a better outcome.
Measured: Baseline, at 6 months and at 12 months after the beginning of treatment
Change from Baseline Number of Nouns and Verbs at 6 months and 12 months
Comparing the pre- and post-treatment number of nouns and verbs between groups.
A parent-child interaction video will be taken; speech of children will be transcribed. The number of nouns and verbs will be counted. The greater number of nouns and verbs means a better outcome.
Measured: Baseline, at 6 months and at 12 months after the beginning of treatment
Change from Baseline Prosody in terms of loudness variation at 6 months and 12 months
Comparing the pre- and post-treatment loudness variation between groups.
A parent-child interaction video will be taken. Audio with the speech of children will be extracted. Loudness of the audio will be assessed with Praat, an acoustic analysis software. The reduction of the loudness variation means a better outcome.
Measured: Baseline, at 6 months and at 12 months after the beginning of treatment
Change from Baseline Prosody in terms of fundamental frequency at 6 months and 12 months
Comparing the pre- and post-treatment fundamental frequency between groups.
A parent-child interaction video will be taken. Audio with the speech of children will be extracted. The fundamental frequency of the audio will be assessed with Praat, an acoustic analysis software. The reduction of fundamental frequency means a better outcome.
Measured: Baseline, at 6 months and at 12 months after the beginning of treatment
Change from Baseline Communication at 6 months and 12 months
Comparing the pre- and post-treatment communication ability measured by the Communication domain of Vineland Adaptive Behavior Scales, Third Edition (VABS-3) between groups.
The VABS-3 score v-score ranges from 1 to 24; the higher VABS-3 scores mean a better outcome.
Measured: Baseline, at 6 months and at 12 months after the beginning of treatment
Change from Baseline Socialization at 6 months and 12 months
Comparing the pre- and post-treatment socialization ability measured by the Socialization domain of Vineland Adaptive Behavior Scales, Third Edition (VABS-3) between groups.
The VABS-3 score v-score ranges from 1 to 24; the higher VABS-3 scores mean a better outcome.
Measured: Baseline, at 6 months and at 12 months after the beginning of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Jul 2022
- Primary completion31 Jan 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- 144 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455411
- Sponsor's protocol ID
- CRFASD-22
- Status last verified
- Oct 2026
- First submitted
- 29 Jun 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
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
- NCT05455411
- Acronym / sponsor ID
- CRFASD-22
- Keywords
- Autism Spectrum Disorder, Parent-implemented Intervention, Social Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 13 Jul 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 treatment as effective in reducing the severity of social communication deficits in preschool children with ASD. 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 treatment outcome is highly variable despite study-level efficacy data, most likely due to unique child and parent factors that make treatment 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 treatment 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 treatment taught by a speech therapist in an Individual (one-on-one) format is more effective than treatment taught in a Group format (up to 8 families learning together) at the study level. The Individual format is at least 4 times more expensive than the Group format; its relative treatment effect must be empirically ascertained to justify its cost. The investigators will then evaluate what combinations of parent and child behavioral and neural 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 Individual format of intervention. Machine-learning analytics with cross-validation will be used in constructing predictive models of treatment 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 ASD 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 children with ASD as individuals.
Detailed description
BACKGROUND:
For parents of children with Autism Spectrum Disorder (ASD), the primary concern is to minimize the impact of the disorder, 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 ASD intervention options that have different costs and intervention delivery formats (individual vs. group) 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.]
ASD affects 14 per 10,000 (0.14%) children in Hong Kong and 39.23 per 10,000 in Mainland China. Social communication is a deficit domain of ASD, and about 29% of preschoolers with ASD have severe verbal deficits. Intervention through pharmaceutical means remains elusive, leaving behavioral interventions the most realistic and immediate avenue of treatment. 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 child with ASD.
AIM OF STUDY:
Objective 1: The investigators will first ascertain whether parent-implemented communication treatment taught by a speech therapist in an Individual (one-on-one) format is more effective than treatment taught in a Group format (up to 8 families learning together) at the study level.
Objective 2: The investigators will examine pre-treatment child and parent variables simultaneously and construct predictive models of response to the two treatment options (group, less costly vs. individual, more costly) at the individual-child level. Both neural and non-neural variables will be examined to increase the precision of prediction.
HYPOTHESIS:
By the investigators' estimate, even after the number of contact hours is controlled, the group format is at least 4 times cheaper than the one-on-one format. Individual sessions allow for individualization, clearer explanation and modeling of the strategies, as well as some clinician-to-child stimulations that cannot be achieved by lectures. Though it may seem obvious that this individual format must produce better results, it is possible that the group format may be more effective due to better social support offered by peers.
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 TrainingA group-based parent-implemented social communication treatment program for up to 8 parents of children with autism spectrum disorder |
| Individual-based Parent-implemented Social Communication Training | Active comparator | Behavioral: Individual-based Parent-implemented TrainingAn individual-based parent-implemented social communication treatment program for a parent of a child with autism spectrum disorder |
Who may qualify
- Ages
- 24 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 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.
- ADOS-2 score in the spectrum range (for Modules 1 \& 2) or mild-to-moderate concern range (for Toddler Module)
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 treatment 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 TrainingA group-based social communication training for parents of preschoolers with autism spectrum disorder 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 |
| Individual-based Parent-implemented TrainingAn individual-based social communication training for parents of preschoolers with autism spectrum disorder will be taught by a speech therapist online in a one-on-one format (approximately 25 hours distributed over 6 months). | Behavioural | Individual-based Parent-implemented Social Communication Training |
Primary outcome
Change from Baseline Social Affect at 12 months
Time frame: Baseline and at 12 months after the beginning of treatment
Comparing the pre- and post-treatment social affect measured by the Social Affect subscore of Autism Diagnostic Observation Schedule™, Second Edition (ADOS-2) between groups. The Social Affect subscore of ADOS-2 ranges from 0 to 20; the higher ADOS-2 scores mean a worse outcome.
Change from Baseline Receptive Language at 12 months
Time frame: Baseline and at 12 months after the beginning of treatment
Comparing the pre- and post-treatment receptive language measured by the Receptive Language domain of Mullen Scales of Early Learning (MSEL) between groups. The MSEL score T-score ranges from 20 to 80; the higher MSEL scores mean a better outcome.
Change from Baseline Expressive Language at 12 months
Time frame: Baseline and at 12 months after the beginning of treatment
Comparing the pre- and post-treatment expressive language measured by the Expressive Language domain of Mullen Scales of Early Learning (MSEL) between groups. The MSEL score T-score ranges from 20 to 80; the higher MSEL scores mean a better outcome.
7 secondary outcomes
Change from Baseline Number of Parent-child Turn-taking at 6 months and 12 months
Time frame: Baseline, at 6 months and at 12 months after the beginning of treatment
Change from Baseline Mean Length of Utterance at 6 months and 12 months
Time frame: Baseline, at 6 months and at 12 months after the beginning of treatment
Change from Baseline Number of Nouns and Verbs at 6 months and 12 months
Time frame: Baseline, at 6 months and at 12 months after the beginning of treatment
Change from Baseline Prosody in terms of loudness variation at 6 months and 12 months
Time frame: Baseline, at 6 months and at 12 months after the beginning of treatment
Change from Baseline Prosody in terms of fundamental frequency at 6 months and 12 months
Time frame: Baseline, at 6 months and at 12 months after the beginning of treatment
Change from Baseline Communication at 6 months and 12 months
Time frame: Baseline, at 6 months and at 12 months after the beginning of treatment
Change from Baseline Socialization at 6 months and 12 months
Time frame: Baseline, at 6 months and at 12 months after the beginning of treatment
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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based Parent-implemented Training and Individual-based Parent-implemented Training in people with Autism Spectrum Disorder and Autism, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
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 2 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 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?
Change from Baseline Social Affect at 12 months (time frame: Baseline and at 12 months after the beginning of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.