Autism Spectrum DisorderNCT05857813
Social Skills Training Group Effectiveness in Adolescents With Autism Spectrum Disorder
A study testing Program for the Education and Enrichment of Relational Skills (PEERS®) in people with Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Autism spectrum disorders (ASD) is a neurodevelopmental disorder characterized by persistent deficits in social communication and social interaction across multiple contexts, and the presence of restricted, repetitive behavior and interests, affecting 1 in 68 children. Read more about this study
- Who is it for?
- Ages 11 to 20 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Program for the Education and Enrichment of Relational Skills (PEERS®)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 12 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 11 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- aged 11-20 years, currently enrolled in school between the sixth grade of elementary school and the third year of high school
- with a clinical diagnosis of ASD from a licensed mental health or medical professional based on DSM-5
- experiencing social difficulties as reported by parents in a structured intake interview
- scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD
- demonstrating verbal fluency in Chinese
- with a full-scale IQ > 70 on WAIS-IV
- with motivation to participate in the intervention;
- with a caregiver who was fluent in Chinese and willing to participate as a social coach in the study.
Who cannot join
- a history of major mental illness (e.g., bipolar affective disorder, schizophrenia, or psychosis) or neurological diseases that might hinder participation in the treatment
- visual impairment and/or hearing impairment that would preclude participation in group-based social activities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Yi-Ling Chien, MD, PhD, +886223123456#66013, chienyiling@gmail.com
About this study
Official title: Establishment of Social Skills Training Group in Adolescents With Autism Spectrum Disorder and Effectiveness Analysis
Autism spectrum disorders (ASD) is a neurodevelopmental disorder characterized by persistent deficits in social communication and social interaction across multiple contexts, and the presence of restricted, repetitive behavior and interests, affecting 1 in 68 children. Although atypical social deficits onset in early childhood, their social relationships with peers may remain a challenge or even worsen for individuals with ASD throughout the school years and beyond, as social contexts increase in complexity and pose higher social expectations.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Program for the Education and Enrichment of Relational Skills (PEERS®)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program for the Education and Enrichment of Relational Skills (PEERS®)Behavioural
developed at the University of California, Los Angeles (E. A. Laugeson \& F. Frankel, 2010). This is a parent-assisted, manualized social skills training program that addresses crucial areas of social functioning for adolescents. Psycho-education and cognitive-behavioral therapy techniques are employed to help adolescents develop ecologically valid skills for making and maintaining friendships.
| Study group | Role | What they receive |
|---|---|---|
| ASD teens and their caregiver | Experimental | Teens: (1) aged 11-20 years, currently enrolled in school between the sixth grade of elementary school and the third year of high school; (2) with a clinical diagnosis of ASD from a licensed mental health or medical professional based on DSM-5; (3) experiencing social difficulties as reported by parents in a structured intake interview; (4) scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD (5) demonstrating verbal fluency in Chinese (6) with a full-scale IQ > 70 on WAIS-IV; (7) with motivation to participate in the intervention; (8) with a caregiver who was fluent in Chinese and willing to participate as a social coach in the study.
Parents: (1) demonstrating verbal fluency in Chinese (2) with motivation to participate in the intervention and assist their children to do the homework assignments. Receives: Behavioral: Program for the Education and Enrichment of Relational Skills (PEERS®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism Diagnostic Interview-Revised (ADI-R)
Interview with caregiver of autistic participants. Total of 93 items coding from 1 to 9. Higher the score, worse the syptom
Measured: 7 weeks
The Autism Diagnostic Observation Schedule (ADOS)
Observe the autistic participant during the interview. the examinee's condition is classified as autism spectrum if the combined score across two domains of social interaction and communication is ≥7, and as autism if the combined score is ≥12. In Module 2, a combined score of ≥8 corresponds to autism spectrum, and a combined score of ≥12 corresponds to autism
Measured: 7 weeks
Autism Spectrum Quotient (AQ)
50 statement scoring from 1 to 4. higher the score, worse the syptom
Measured: 7 weeks
Friendship Quality Scale (FQS)
23 questions scoring from 1 to 5. Higher the score, better the quality of friendship
Measured: 7 weeks
The Assessing Emotions Scale (AES)
score range from 33 to 165. higher the score, better the emotional intelligence
Measured: 7 weeks
Social Responsiveness Scale (SRS)
65 questions range from 1 to 4. higher the score, worse the symptom.
Measured: 7 weeks
Social Adjustment Inventory for Children and Adolescents (SAICA)
17 scenarios scoring from 1 to 4. Higher the score, better the capability
Measured: 7 weeks
Quality of Play Questionnaire (QPQ)
10 questions scoring from 0 to 3. Higher the score, worse the quality of play. Also, asked for frequency and number of participant in the play
Measured: 7 weeks
Test of Adolescents Social Skills Knowledge (TASSK)
score range from 0 to 22. Higher the score, greater the knowledge of taught social skills
Measured: 7 weeks
Empathy Quotient (EQ)
60 questions score from 0 to 3. Higher the score, greater the empathy
Measured: 7 weeks
Friendship Questionnaire (FQ)
score from 0 to 135. higher the score, the more enjoyment of friendship
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start1 Jan 2022
- Primary completion12 Jul 2027 (estimated)
- Study completion12 Jul 2027 (estimated)
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 National Taiwan University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857813
- Sponsor's protocol ID
- 202109033RIND
- Status last verified
- Jul 2026
- First submitted
- 13 Apr 2023
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Social Skills Training Group in Adolescents With Autism Spectrum Disorder and Effectiveness Analysis
- ClinicalTrials.gov ID
- NCT05857813
- Acronym / sponsor ID
- 202109033RIND
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 12 Jul 2027 (estimated)
- Study completion
- 12 Jul 2027 (estimated)
- First posted
- 15 May 2023 (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.
Autism spectrum disorders (ASD) is a neurodevelopmental disorder characterized by persistent deficits in social communication and social interaction across multiple contexts, and the presence of restricted, repetitive behavior and interests, affecting 1 in 68 children. Although atypical social deficits onset in early childhood, their social relationships with peers may remain a challenge or even worsen for individuals with ASD throughout the school years and beyond, as social contexts increase in complexity and pose higher social expectations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASD teens and their caregiver | Experimental | Behavioral: Program for the Education and Enrichment of Relational Skills (PEERS®)Teens: (1) aged 11-20 years, currently enrolled in school between the sixth grade of elementary school and the third year of high school; (2) with a clinical diagnosis of ASD from a licensed mental health or medical professional based on DSM-5; (3) experiencing social difficulties as reported by parents in a structured intake interview; (4) scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD (5) demonstrating verbal fluency in Chinese (6) with a full-scale IQ > 70 on WAIS-IV; (7) with motivation to participate in the intervention; (8) with a caregiver who was fluent in Chinese and willing to participate as a social coach in the study. Parents: (1) demonstrating verbal fluency in Chinese (2) with motivation to participate in the intervention and assist their children to do the homework assignments. |
Who may qualify
- Ages
- 11 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- aged 11-20 years, currently enrolled in school between the sixth grade of elementary school and the third year of high school
- with a clinical diagnosis of ASD from a licensed mental health or medical professional based on DSM-5
- experiencing social difficulties as reported by parents in a structured intake interview
- scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD
- demonstrating verbal fluency in Chinese
Key exclusion criteria (2 listed)
- a history of major mental illness (e.g., bipolar affective disorder, schizophrenia, or psychosis) or neurological diseases that might hinder participation in the treatment
- visual impairment and/or hearing impairment that would preclude participation in group-based social activities.
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 |
|---|---|---|
| Program for the Education and Enrichment of Relational Skills (PEERS®)developed at the University of California, Los Angeles (E. A. Laugeson \& F. Frankel, 2010). This is a parent-assisted, manualized social skills training program that addresses crucial areas of social functioning for adolescents. Psycho-education and cognitive-behavioral therapy techniques are employed to help adolescents develop ecologically valid skills for making and maintaining friendships. | Behavioural | ASD teens and their caregiver |
Primary outcome
Autism Diagnostic Interview-Revised (ADI-R)
Time frame: 7 weeks
Interview with caregiver of autistic participants. Total of 93 items coding from 1 to 9. Higher the score, worse the syptom
The Autism Diagnostic Observation Schedule (ADOS)
Time frame: 7 weeks
Observe the autistic participant during the interview. the examinee's condition is classified as autism spectrum if the combined score across two domains of social interaction and communication is ≥7, and as autism if the combined score is ≥12. In Module 2, a combined score of ≥8 corresponds to autism spectrum, and a combined score of ≥12 corresponds to autism
Autism Spectrum Quotient (AQ)
Time frame: 7 weeks
50 statement scoring from 1 to 4. higher the score, worse the syptom
Friendship Quality Scale (FQS)
Time frame: 7 weeks
23 questions scoring from 1 to 5. Higher the score, better the quality of friendship
The Assessing Emotions Scale (AES)
Time frame: 7 weeks
score range from 33 to 165. higher the score, better the emotional intelligence
Social Responsiveness Scale (SRS)
Time frame: 7 weeks
65 questions range from 1 to 4. higher the score, worse the symptom.
Social Adjustment Inventory for Children and Adolescents (SAICA)
Time frame: 7 weeks
17 scenarios scoring from 1 to 4. Higher the score, better the capability
Quality of Play Questionnaire (QPQ)
Time frame: 7 weeks
10 questions scoring from 0 to 3. Higher the score, worse the quality of play. Also, asked for frequency and number of participant in the play
Test of Adolescents Social Skills Knowledge (TASSK)
Time frame: 7 weeks
score range from 0 to 22. Higher the score, greater the knowledge of taught social skills
Empathy Quotient (EQ)
Time frame: 7 weeks
60 questions score from 0 to 3. Higher the score, greater the empathy
Friendship Questionnaire (FQ)
Time frame: 7 weeks
score from 0 to 135. higher the score, the more enjoyment of friendship
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program for the Education and Enrichment of Relational Skills (PEERS®) in people with Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
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 8 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Ling Chien (+886223123456#66013, chienyiling@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autism Diagnostic Interview-Revised (ADI-R) (time frame: 7 weeks). The study lists 11 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 31 Jul 2026.