NCT05875376

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 25, 2023

Status Verified

August 1, 2022

Enrollment Period

3 years

First QC Date

April 14, 2023

Last Update Submit

May 23, 2023

Conditions

Keywords

autism spectrum disorder, couple therapy

Outcome Measures

Primary Outcomes (5)

  • The Autism Diagnostic Observation Schedule, ADOS

    range from 0 to 8 for each item. Higher the score, worse the symptoms

    6 weeks

  • Autism Spectrum Quotient

    range from 0 to 3 for each item, total score of 50. Higher the score, wrose the related symptoms.

    6 weeks

  • Empathy Quotient

    range from 0 to 3 for each item, total score of 40. Higher the score, worse the empathy

    6 weeks

  • Social Responsiveness Scale, SRS

    65 questions, range from 1 to 5. Higher the score, worse the symptom

    6 weeks

  • Quality of socialization questionnaire, QSQ

    selected part of the questionnaire to examine the quality of interaction. Higher the score, better the socialization

    6 weeks

Study Arms (1)

ASD couple

EXPERIMENTAL

Either one of the couple has ASD diagnosis, including couples who are married or in romantic relationship.

Behavioral: Couple group therapy

Interventions

1. Introduction of "I" statements 2. Focus of each conversation 3. Emotion acknowledgement 4. Self-assurance and positive feedback 5. teamwork and cooperation 6. Reflection

ASD couple

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Psychiatric disorder (i.e. schizophrenia, substance abuse)
  • unable to communication (i.e. visual or auditory impairment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2023

First Posted

May 25, 2023

Study Start

January 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

May 25, 2023

Record last verified: 2022-08

Locations