- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05875376
Establish the Couple Intervention Program for Adults With Autism Spectrum Disorder
May 23, 2023 updated by: National Taiwan University Hospital
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yi-Ling Chien
- Phone Number: +886223123456#66013
- Email: chienyiling@gmail.com
Study Locations
-
-
-
Taipei, Taiwan
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Yi-Ling Chien, MD, PhD
- Phone Number: +886223123456#66013
- Email: chienyiling@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Psychiatric disorder (i.e. schizophrenia, substance abuse)
- unable to communication (i.e. visual or auditory impairment)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ASD couple
Either one of the couple has ASD diagnosis, including couples who are married or in romantic relationship.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Autism Diagnostic Observation Schedule, ADOS
Time Frame: 6 weeks
|
range from 0 to 8 for each item.
Higher the score, worse the symptoms
|
6 weeks
|
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.
|
6 weeks
|
Empathy Quotient
Time Frame: 6 weeks
|
range from 0 to 3 for each item, total score of 40.
Higher the score, worse the empathy
|
6 weeks
|
Social Responsiveness Scale, SRS
Time Frame: 6 weeks
|
65 questions, range from 1 to 5. Higher the score, worse the symptom
|
6 weeks
|
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
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
April 14, 2023
First Submitted That Met QC Criteria
May 23, 2023
First Posted (Actual)
May 25, 2023
Study Record Updates
Last Update Posted (Actual)
May 25, 2023
Last Update Submitted That Met QC Criteria
May 23, 2023
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202106091RINC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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