- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07234253
Sexuality and Relationship Education Program for Autistic Young Adults in South Korea
Developing and Evaluating a Culturally Sensitive Sexual Health Education Program for Autistic Young Adults in South Korea With Input From a Community Advisory Board
The goal of this single-arm clinical trial is to conduct a preliminary evaluation of Our Love, Our Style, a group-based sexuality and relationship education program for autistic young adults in South Korea. The study aims to examine the preliminary efficacy of the program by assessing increases in sexuality knowledge, sexual and relationship behaviors, and motivation. It will also evaluate the feasibility and acceptability of implementing the program among Korean autistic young adults.
Participants will receive a 10-session, online, group-based program (90 minutes per session, once a week for 10 weeks) delivered via telehealth. The program is adapted to the Korean cultural context and tailored to the needs of autistic young adults aged 18-35 years. It will cover the following topics: social relationships (e.g., distinguishing types of relationships, apologizing, and refusing), romantic relationships, consent, sexual behavior, reproduction, prevention of sexual harassment, online and social media use related to sexuality, gender, and sexual orientation.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Seoul, South Korea
- Korea University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- previous medical diagnosis of autism spectrum disorder (ASD) or ASD based on DSM-5 using Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
- Verbal ability sufficient to produce full sentences (i.e. ADOS-2 Module 4 language level)
- Full-Scale IQ equal to or above 70
Exclusion Criteria:
- Presence of prominent hallucinations or delusions
Study Plan
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 |
|---|---|
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Experimental: Intervention Group
Autistic young adults will receive a group-based sexuality and relationship education program delivered in a telehealth format over 10 sessions (90 minutes per session, once a week for 10 weeks).
The program will cover the following topics: social relationship (e.g., distinguishing types of relationships, apologizing, and refusing), romantic relationships, consent, sexual behavior, reproduction, prevention of sexual harassment, online and social media use related to sexuality, gender, and sexual orientation.
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The intervention will consist of an online, group-based sexuality and relationship education program delivered over 10 sessions (90 minutes per session, once a week for 10 weeks).
The program will cover the following topics, adapted to the Korean cultural context and the needs of autistic young adults aged 18-35 years: social relationships (e.g., distinguishing types of relationships, apologizing, and refusing), romantic relationships, consent, sexual behavior, reproduction, prevention of sexual harassment, online and social media use related to sexuality, gender, and sexual orientation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Psychosexual Knowledge Test (PKT)
Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up).
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A 37-item multiple-choice test designed to assess a broad range of psychosexual knowledge, from understanding physical terminology to applied sexual and psychological concepts.
Each item is scored as True/False
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Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up).
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Perceived Knowledge Questionnaire (PKQ)
Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up).
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A 5-item self-report measure evaluating participants' perceived level of sexual health knowledge.
Items are answered in a True/False format.
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Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up).
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Korean Relationship and Sexuality Scale (KRSS)
Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up).
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A 150-item self-report scale developed to comprehensively evaluate sexual health knowledge and understanding of relationships, corresponding to the content covered in the intervention program.
Visual aids are provided to support autistic participants' comfort with visual materials.
Each item is rated as Agree or Disagree.
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Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up).
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Sexual Desire Inventory-2 (SDI-2)
Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up).
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A 14-item self-report questionnaire measuring the frequency and intensity of sexual desire across various contexts.
Items are rated on an 8-point scale ranging from 0 (Not at all) to 7 (More than once a day).
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Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up).
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Self-Efficacy in Romantic Relationships Scale
Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up).
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A 12-item scale assessing self-efficacy and beliefs regarding one's ability to maintain and manage romantic relationships.
Each item is rated on a 9-point Likert scale from 1 (Strongly disagree) to 9 (Strongly agree).
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Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up).
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Sexual and Dating Experiences Questionnaire
Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up).
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A 7-item multiple-choice questionnaire evaluating participants' experiences with various intimate and dating behaviors.
Each item is answered as Never, Once or twice, or More than twice.
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Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up).
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Sexual Experience Questionnaire (SEQ)
Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up).
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A 12-item instrument assessing the frequency of diverse sexual experiences.
Responses are recorded using a four-point frequency scale: Never, Once, A few times, or Many times.
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Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up).
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Program Feasibility Survey
Time Frame: post-intervention (1 week after the completion of the intervention)
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This questionnaire will be completed by participants at the end of the intervention program to assess the feasibility of the intervention.
It includes items evaluating the practicality and usability of the program (e.g., "The online platform was easy to use," "I was able to find time to complete assigned tasks").
Each item is rated on a 5-point Likert scale (1 = strongly disagree, 3 = neutral, 5 = strongly agree).
Scores for each item range from 1 to 5, with higher scores indicating that participants perceived the program as more feasible.
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post-intervention (1 week after the completion of the intervention)
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Program Acceptability Survey
Time Frame: post-intervention (1 week after the completion of the intervention)
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This questionnaire will be completed by participants at the end of the intervention program to assess the acceptability and overall satisfaction with the intervention.
It includes items evaluating perceived benefits of the sessions (e.g., "I benefited from the sessions with the interventionist").
Each item is rated on a 5-point Likert scale (1 = strongly disagree, 3 = neutral, 5 = strongly agree).
Scores for each item range from 1 to 5, with higher scores indicating that participants perceived the program as more acceptable.
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post-intervention (1 week after the completion of the intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Korean-Adolescents/Adults Sensory Profile (K-AASP)
Time Frame: Baseline (pre-intervention)
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A 60-item self-report measure assessing behavioral responses to everyday sensory experiences among individuals aged 11-65 years.
Each item is rated on a 5-point scale from Almost never to Almost always.
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Baseline (pre-intervention)
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UCLA Loneliness Scale (Korean Short Form)
Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention follow-up.
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An 8-item short form of the UCLA Loneliness Scale assessing perceived loneliness using a 4-point Likert scale (1 = Never to 4 = Often).
Higher scores indicate greater loneliness.
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Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention follow-up.
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Loneliness and Social Isolation Scale
Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention follow-up.
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A 6-item self-report measure assessing both objective and subjective dimensions of social isolation, including social networks, perceived social support, and loneliness.
Each item is rated from 0 to 3.
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Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention follow-up.
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Discrimination and Stigma Scale (DISC-12)
Time Frame: Baseline (pre-intervention)
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A 34-item measure assessing experiences of stigma and discrimination related to mental health issues.
It includes four subdomains: unfair treatment, self-limiting behavior, coping with stigma, and positive discrimination.
Each item is rated on a 4-point scale from Not at all to A lot.
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Baseline (pre-intervention)
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Camouflaging Autistic Traits Questionnaire (CAT-Q)
Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention follow-up.
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A 25-item self-report questionnaire assessing social camouflaging behaviors used to mask autistic traits.
It includes three subscales: Compensation, Masking, and Assimilation.Items are rated on a 7-point Likert scale, and the measure includes reverse-scored items.
Total scores range from 25 to 175, with higher scores indicating greater use of camouflaging behaviors.
The Compensation subscale ranges from 9 to 63 points, and the Masking and Assimilation subscales each range from 8 to 56 points, with higher scores reflecting more frequent use of the respective camouflaging strategies.
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Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention follow-up.
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Beck Depression Inventory (BDI)
Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention follow-up.
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A 21-item self-report instrument measuring the severity of depressive symptoms experienced during the past week.
Each item is rated on a 0-3 scale, yielding a total score range of 0-63.
Higher scores indicate more severe depressive symptoms.
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Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention follow-up.
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Beck Anxiety Inventory (BAI)
Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention follow-up.
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A 21-item self-report instrument assessing the severity of anxiety symptoms, including cognitive, emotional, and physiological aspects of anxiety and panic.
Each item is rated on a 0-3 scale, yielding a total score range of 0-63.
Higher scores indicate more severe anxiety symptoms.
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Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention follow-up.
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Relationships, Employment, Autonomy, and Life Satisfaction Scale (REALS)
Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention follow-up.
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A self-report measure developed for adults with autism or other intellectual and developmental disabilities.
It assesses 19 life domains-including relationships, employment, autonomy, daily living, and satisfaction-using ratings of frequency, support, and satisfaction.
The REALS provides several types of response options.
Frequency items, used when the key question concerns how often a person engages in a particular behavior, are rated on a 5-point scale from 0 (never) to 4 (often), with higher scores indicating more frequent engagement.
Support items, used to understand the level of assistance needed in a domain or the degree to which an individual can perform tasks independently, are rated from 0 to 4, where higher scores indicate greater independence and less need for support.
Satisfaction items, which assess how satisfied an individual is with various aspects of their life, are rated on a 0-3 scale, with higher scores reflecting greater satisfaction in that domain.
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Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention follow-up.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Boin Choi, PhD, Ewha Womans University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-2025-0055-10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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