Autism Spectrum DisorderNCT05875376
Establish the Couple Intervention Program for Adults With Autism Spectrum Disorder
A study testing Couple group therapy in people with Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The development of adult intimate relationships and the transition into couplehood are part of most people's life cycles, but these transitions become very challenging for individuals diagnosed with autism spectrum disorder (ASD) in as much as social interactions, emotional communication, and reciprocity, which are… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Couple group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- one person of each couple has either Autism Spectrum Disorder diagnosis or the autism spectrum quotient scoring above or equal to 26
- able to communicate in Chinese
- Wechsler Intelligence scoring above 70
Who cannot join
- Psychiatric disorder (i.e. schizophrenia, substance abuse)
- unable to communication (i.e. visual or auditory impairment)
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
The development of adult intimate relationships and the transition into couplehood are part of most people's life cycles, but these transitions become very challenging for individuals diagnosed with autism spectrum disorder (ASD) in as much as social interactions, emotional communication, and reciprocity, which are essential for interpersonal relationships, are made more difficult due to the condition itself. In the Adult ASD Clinic of National Taiwan University Hospital, we observe that the wives of the ASD husband suffer from long-term frustration, loneliness and helplessness, and are frequently experience anxiety and depression, that in turns changes the family's function and impacts on children's mental health. To date, there are limited intervention models focusing on couple therapy for ASD adults (or neurodiverse couple). Given the strong needs of clinical service, this study aims to identify the common problems of the ASD couples and develop a program to improve their partner relationships.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Couple group therapy
- Keywords
- autism spectrum disorder, couple therapy
- 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.
Couple group therapyBehavioural
- Introduction of "I" statements
- Focus of each conversation
- Emotion acknowledgement
- Self-assurance and positive feedback
- teamwork and cooperation
- Reflection
| Study group | Role | What they receive |
|---|---|---|
| ASD couple | Experimental | Either one of the couple has ASD diagnosis, including couples who are married or in romantic relationship. Receives: Behavioral: Couple group therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Autism Diagnostic Observation Schedule, ADOS
range from 0 to 8 for each item. Higher the score, worse the symptoms
Measured: 6 weeks
Autism Spectrum Quotient
range from 0 to 3 for each item, total score of 50. Higher the score, wrose the related symptoms.
Measured: 6 weeks
Empathy Quotient
range from 0 to 3 for each item, total score of 40. Higher the score, worse the empathy
Measured: 6 weeks
Social Responsiveness Scale, SRS
65 questions, range from 1 to 5. Higher the score, worse the symptom
Measured: 6 weeks
Quality of socialization questionnaire, QSQ
selected part of the questionnaire to examine the quality of interaction. Higher the score, better the socialization
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Jan 2022
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT05875376
- Sponsor's protocol ID
- 202106091RINC
- Status last verified
- Jul 2026
- First submitted
- 14 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
- Establish the Couple Intervention Program for Adults With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05875376
- Acronym / sponsor ID
- 202106091RINC
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism spectrum disorder, couple therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 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.
The development of adult intimate relationships and the transition into couplehood are part of most people's life cycles, but these transitions become very challenging for individuals diagnosed with autism spectrum disorder (ASD) in as much as social interactions, emotional communication, and reciprocity, which are essential for interpersonal relationships, are made more difficult due to the condition itself. In the Adult ASD Clinic of National Taiwan University Hospital, we observe that the wives of the ASD husband suffer from long-term frustration, loneliness and helplessness, and are frequently experience anxiety and depression, that in turns changes the family's function and impacts on children's mental health. To date, there are limited intervention models focusing on couple therapy for ASD adults (or neurodiverse couple). Given the strong needs of clinical service, this study aims to identify the common problems of the ASD couples and develop a program to improve their partner relationships.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASD couple | Experimental | Behavioral: Couple group therapyEither one of the couple has ASD diagnosis, including couples who are married or in romantic relationship. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- one person of each couple has either Autism Spectrum Disorder diagnosis or the autism spectrum quotient scoring above or equal to 26
- able to communicate in Chinese
- Wechsler Intelligence scoring above 70
Key exclusion criteria (2 listed)
- Psychiatric disorder (i.e. schizophrenia, substance abuse)
- unable to communication (i.e. visual or auditory impairment)
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 |
|---|---|---|
| Couple group therapy1. Introduction of "I" statements 2. Focus of each conversation 3. Emotion acknowledgement 4. Self-assurance and positive feedback 5. teamwork and cooperation 6. Reflection | Behavioural | ASD couple |
Primary outcome
The Autism Diagnostic Observation Schedule, ADOS
Time frame: 6 weeks
range from 0 to 8 for each item. Higher the score, worse the symptoms
Autism Spectrum Quotient
Time frame: 6 weeks
range from 0 to 3 for each item, total score of 50. Higher the score, wrose the related symptoms.
Empathy Quotient
Time frame: 6 weeks
range from 0 to 3 for each item, total score of 40. Higher the score, worse the empathy
Social Responsiveness Scale, SRS
Time frame: 6 weeks
65 questions, range from 1 to 5. Higher the score, worse the symptom
Quality of socialization questionnaire, QSQ
Time frame: 6 weeks
selected part of the questionnaire to examine the quality of interaction. Higher the score, better the socialization
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 Couple group therapy 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 3 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?
The Autism Diagnostic Observation Schedule, ADOS (time frame: 6 weeks). The study lists 5 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.