Establish the Couple Intervention Program for Adults With Autism Spectrum Disorder
Primary Purpose
Autism Spectrum Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Couple group therapy
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring autism spectrum disorder, couple therapy
Eligibility Criteria
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)
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ASD couple
Arm Description
Either one of the couple has ASD diagnosis, including couples who are married or in romantic relationship.
Outcomes
Primary Outcome Measures
The Autism Diagnostic Observation Schedule, ADOS
range from 0 to 8 for each item. Higher the score, worse the symptoms
Autism Spectrum Quotient
range from 0 to 3 for each item, total score of 50. Higher the score, wrose the related symptoms.
Empathy Quotient
range from 0 to 3 for each item, total score of 40. Higher the score, worse the empathy
Social Responsiveness Scale, SRS
65 questions, range from 1 to 5. Higher the score, worse the symptom
Quality of socialization questionnaire, QSQ
selected part of the questionnaire to examine the quality of interaction. Higher the score, better the socialization
Secondary Outcome Measures
Full Information
NCT ID
NCT05875376
First Posted
April 14, 2023
Last Updated
May 23, 2023
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05875376
Brief Title
Establish the Couple Intervention Program for Adults With Autism Spectrum Disorder
Official Title
Establish the Couple Intervention Program for Adults With Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
autism spectrum disorder, couple therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ASD couple
Arm Type
Experimental
Arm Description
Either one of the couple has ASD diagnosis, including couples who are married or in romantic relationship.
Intervention Type
Behavioral
Intervention Name(s)
Couple group therapy
Intervention Description
Introduction of "I" statements
Focus of each conversation
Emotion acknowledgement
Self-assurance and positive feedback
teamwork and cooperation
Reflection
Primary Outcome Measure Information:
Title
The Autism Diagnostic Observation Schedule, ADOS
Description
range from 0 to 8 for each item. Higher the score, worse the symptoms
Time Frame
6 weeks
Title
Autism Spectrum Quotient
Description
range from 0 to 3 for each item, total score of 50. Higher the score, wrose the related symptoms.
Time Frame
6 weeks
Title
Empathy Quotient
Description
range from 0 to 3 for each item, total score of 40. Higher the score, worse the empathy
Time Frame
6 weeks
Title
Social Responsiveness Scale, SRS
Description
65 questions, range from 1 to 5. Higher the score, worse the symptom
Time Frame
6 weeks
Title
Quality of socialization questionnaire, QSQ
Description
selected part of the questionnaire to examine the quality of interaction. Higher the score, better the socialization
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Ling Chien
Phone
+886223123456#66013
Email
chienyiling@gmail.com
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Ling Chien, MD, PhD
Phone
+886223123456#66013
Email
chienyiling@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Establish the Couple Intervention Program for Adults With Autism Spectrum Disorder
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