Autism Spectrum DisorderNCT05884853
The Plasticity of Social Brain Network in Adults With Autism Spectrum Disorder
A study testing PEERS in people with Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
"Social brain" refers to brain regions dedicated to processing social information and enabling us to recognize and evaluate others' mental states. The social brain hypothesis suggests that our brains evolve to navigate complex social systems. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- PEERS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2021to 31 Dec 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age between 18 and 50
- diagnosed with ASD from licensed mental health or medical professional based on DSM5
- have social problems
- motivated to participate in the treatment
- fluent in chinese
- caregiver also fluent in chinese and motivated to participate
- had a full-scale IQ > 70 on WAIS-IV
- scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD.
Who cannot join
- history of major mental illness, such as bipolar affective disorder, schizophrenia, psychosis, or neurological diseases
- visual impairment and/or hearing impairment
- any metal, electronic part that cannot be removed from the body, or being pregnant, which may not be able to use fMRI scan.
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, Zhongzheng Dist., 100229
Yi-Ling Chien, MD, PhD, +886223123456 ext. 66013, chienyiling@gmail.com
About this study
"Social brain" refers to brain regions dedicated to processing social information and enabling us to recognize and evaluate others' mental states. The social brain hypothesis suggests that our brains evolve to navigate complex social systems. The social brain is hypothesized to consist of a distributed network including the posterior superior temporal sulcus (pSTS), the dorsal and ventral medial prefrontal cortices (dmPFC and vmPFC), ACC and posterior cingulate cortex (PCC), the amygdala, the orbital frontal cortex (OFC), and the fusiform gyrus (FG), TPJ, inferior occipital gyrus (IOG), and the insula. Each region serves distinct role while works together to support social processing, including perceiving, interpreting, and generating responses to the intentions, dispositions, and behaviors of others.
- Conditions
- Autism Spectrum Disorder
- Being tested
- 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.
PEERSBehavioural
The Program for the Education and Enrichment of Relational Skills (PEERS®) studies is an evidence-based 16-week group-based social skill training program developed for adolescents and young adults with ASD.
| Study group | Role | What they receive |
|---|---|---|
| ASD group | Experimental | autistic adolescents with their caregiver Receives: Behavioral: PEERS |
| Control group | Sham comparator | healthy control without their caregiver Receives: Behavioral: PEERS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism Diagnostic Interview Revised, ADIR
Interview of the caregivers that covers most developmental and behavioral aspects of ASD. Range from 0 to 8, higher the score, worse the symptom.
Measured: 16 weeks
The Autism Diagnostic Observation Schedule, ADOS
Diagnosing and assess autism. Range from 0 to 8, higher the score, worse the symptom.
Measured: 16 weeks
Autism Spectrum Quotient
50 items, total score range from 0 to 50. Higher the score, worse the symptom
Measured: 16 weeks
Social Responsiveness Scale, Second Edition (SRS-2)
65 items, total score range from 65 to 260. Higher the score, worse the symptom
Measured: 16 weeks
Quality of Socialization Questionnaire (QSQ)
12 items, total score range from 0 to 12.Higher the score, better the frequency and quality of socialization
Measured: 16 weeks
The Empathy Quotient (EQ)
40 items, total score range from 0 to 80. Higher the score, worse the empathy
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 40 autistic adolescents are recruited with their care givers. Also, 40 healthy controls.
- 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
- NCT05884853
- Sponsor's protocol ID
- 202012163RIND
- Status last verified
- Jul 2026
- First submitted
- 4 May 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
- The Plasticity of Social Brain Network in Adults With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05884853
- Acronym / sponsor ID
- 202012163RIND
- 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 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Jun 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.
"Social brain" refers to brain regions dedicated to processing social information and enabling us to recognize and evaluate others' mental states. The social brain hypothesis suggests that our brains evolve to navigate complex social systems. The social brain is hypothesized to consist of a distributed network including the posterior superior temporal sulcus (pSTS), the dorsal and ventral medial prefrontal cortices (dmPFC and vmPFC), ACC and posterior cingulate cortex (PCC), the amygdala, the orbital frontal cortex (OFC), and the fusiform gyrus (FG), TPJ, inferior occipital gyrus (IOG), and the insula. Each region serves distinct role while works together to support social processing, including perceiving, interpreting, and generating responses to the intentions, dispositions, and behaviors of others.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 40 autistic adolescents are recruited with their care givers. Also, 40 healthy controls.
| Arm | Type | Receives |
|---|---|---|
| ASD group | Experimental | Behavioral: PEERSautistic adolescents with their caregiver |
| Control group | Sham comparator | Behavioral: PEERShealthy control without their caregiver |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- age between 18 and 50
- diagnosed with ASD from licensed mental health or medical professional based on DSM5
- have social problems
- motivated to participate in the treatment
- fluent in chinese
Key exclusion criteria (3 listed)
- history of major mental illness, such as bipolar affective disorder, schizophrenia, psychosis, or neurological diseases
- visual impairment and/or hearing impairment
- any metal, electronic part that cannot be removed from the body, or being pregnant, which may not be able to use fMRI scan.
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 |
|---|---|---|
| PEERSThe Program for the Education and Enrichment of Relational Skills (PEERS®) studies is an evidence-based 16-week group-based social skill training program developed for adolescents and young adults with ASD. | Behavioural | ASD group, Control group |
Primary outcome
Autism Diagnostic Interview Revised, ADIR
Time frame: 16 weeks
Interview of the caregivers that covers most developmental and behavioral aspects of ASD. Range from 0 to 8, higher the score, worse the symptom.
The Autism Diagnostic Observation Schedule, ADOS
Time frame: 16 weeks
Diagnosing and assess autism. Range from 0 to 8, higher the score, worse the symptom.
Autism Spectrum Quotient
Time frame: 16 weeks
50 items, total score range from 0 to 50. Higher the score, worse the symptom
Social Responsiveness Scale, Second Edition (SRS-2)
Time frame: 16 weeks
65 items, total score range from 65 to 260. Higher the score, worse the symptom
Quality of Socialization Questionnaire (QSQ)
Time frame: 16 weeks
12 items, total score range from 0 to 12.Higher the score, better the frequency and quality of socialization
The Empathy Quotient (EQ)
Time frame: 16 weeks
40 items, total score range from 0 to 80. Higher the score, worse the empathy
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 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 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: 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. Some participants in this study may receive a placebo. 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, MD, PhD (+886223123456 ext. 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, ADIR (time frame: 16 weeks). The study lists 6 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.