- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07728864
Sexuality and Relationship Education for Autistic Adults: Our Love, Our Style (OLOS)
Development and Evaluation of a Sexuality and Relationship Education for Autistic Adults Using a SMART -Based Adaptive Intervention Approach
The goal of this sequential multiple assignment randomized trial is to conduct a preliminary evaluation of Our Love, Our Style (OLOS), a web-based sexuality and relationship education program for autistic young adults in South Korea. This study aims to develop a tailored sex and relationship education model for autistic adults in collaboration with autistic adult research partners by employing a community-based participatory research (CBPR) approach, and to progressively evaluate and expand the effectiveness of an adaptive intervention that reflects individual learner characteristics using a sequential multiple assignment randomized trial (SMART) design. Through this process, the study seeks to strengthen the sexual health and relationship-building capacities of autistic adults and, ultimately, to promote greater independence, improved quality of life, enhanced autonomy, and social inclusion in South Korea.
Participants will be randomly assigned to one of the two initial groups; the web-based learning group vs. the web-based learning and coaching group. During the first-stage intervention (4 weeks), the web-based learning group engages in individual learning through the sex and relationship education web portal developed in Year 1, while the web-based plus group-coaching group participates in both web-based learning and small-group sessions.
Following the completion of the first-stage intervention, an interim assessment is conducted to evaluate learners' responses, and participants are classified as responders or non-responders according to their quiz performance within the program. Responders maintain the original intervention, whereas non-responders receive an additional, more intensive intervention.
In the second-stage intervention, non-responders in the web-based learning group receive an additional group-coaching component (web-based → web-based + group coaching), whereas non-responders in the web-based plus group-coaching group receive additional individual coaching to provide more intensive learning support (web-based + group coaching → web-based + group coaching + individual coaching). For non-responders, both group coaching and individual coaching are provided either via Zoom or in person according to participant preference, with each session lasting approximately 60 minutes. The intensive learning intervention incorporates more concrete and realistic examples and uses strategies such as modeling, role-play, and quizzes, which are difficult to implement in a web-based format alone, in order to enhance learning effectiveness through real-time interaction and positive reinforcement.
To assess the durability of the intervention effects, pre-intervention, post-intervention, and follow-up assessment outcomes will be compared and analyzed using the evaluation measures to examine the retention of sexual knowledge, changes in relationship-building abilities, and improvements in social skills. Additionally, mental health and quality of life will be examined through supplementary assessment tools. This will allow for a broader understanding of the overall effectiveness and potential benefits of the sex and relationship intervention, as well as an in-depth evaluation of its impact across multiple domains of participants' lives.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Seoul, South Korea
- Ewha Womans 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)
- Among individuals who self-identify as autistic
- Full-Scale IQ equal to or above 70 or self-reported or previous questionnaire K-WAIS-IV or ADOS-2 Module-4
Exclusion Criteria:
- Presence significant cognitive or language difficulties that prevent them from understanding and responding to interview questions
- Presence of prominent hallucinations or delusions
- requires consent from a legal guardian and therefore are unable to provide legal consent for participation in this study on their own
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Web-Based Learning
Participants assigned to this arm receive four weeks of individual web-based learning through the sex and relationship education portal during the first-stage intervention.
At the end of the first-stage intervention, response is assessed.
Responders continue the web-based learning intervention, whereas non-responders receive an additional group-coaching component during the second-stage intervention.
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Participants complete individual learning modules through a web-based sex and relationship education portal developed for autistic adults.
Participants receive structured small-coaching sessions in addition to web-based learning.
Sessions include concrete and realistic examples, modeling, role-play, quizzes, real-time interaction, and positive reinforcement.
Sessions are delivered either via Zoom or in person according to participant preference, with each session lasting approximately 60 minutes.
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Experimental: Web-Based Learning Plus Group Coaching
Participants assigned to this arm receive four weeks of web-based learning plus small-group coaching sessions during the first-stage intervention.
At the end of the first-stage intervention, response is assessed.
Responders continue the same intervention, whereas non-responders receive additional individual coaching during the second-stage intervention.
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Participants complete individual learning modules through a web-based sex and relationship education portal developed for autistic adults.
Participants receive structured small-coaching sessions in addition to web-based learning.
Sessions include concrete and realistic examples, modeling, role-play, quizzes, real-time interaction, and positive reinforcement.
Sessions are delivered either via Zoom or in person according to participant preference, with each session lasting approximately 60 minutes.
An individualized coaching intervention delivered as an intensified second-stage support for non-responders.
Coaching is tailored to participant characteristics and incorporates concrete examples, modeling, role-play, quizzes, real-time interaction, and positive reinforcement.
Sessions are delivered either via Zoom or in person according to participant preference, with each session lasting approximately 60 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Korean-Adolescents/Adults Sensory Profile (K-AASP)
Time Frame: Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up).
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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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Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up).
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Psychosexual Knowledge Test (PKT)
Time Frame: 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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Time Frame: 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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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 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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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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Survey of Sexual Attitudes and Sexual Behaviors Among Male and Female College Students, Including Graduate Students
Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)
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This instrument, developed in Korea for adults, is designed to assess sexual knowledge, sexual attitudes, sexual behaviors, and sex education.
It includes 38 items assessing sexual knowledge and 42 items assessing sexual attitudes.
The sexual behavior domain comprises 10 items on sexual intercourse and sexual experiences, 12 items on sexual violence, and 20 items on internet pornography addiction, while the sex education domain includes 11 items.
Respondents complete each item using either a Likert-type scale or a multiple-choice response format.
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Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)
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Dyadic Adjustment Scale, DAS
Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)
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This is a 32-item self-report questionnaire designed to assess overall adjustment, relationship satisfaction, degree of agreement, and patterns of conflict in marital or intimate partner relationships.
Depending on the item, responses are rated on 5-, 6-, or 7-point scales, or answered in a yes/no format.
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Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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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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 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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The Korean version of the World Health Organization Quality of Life scale (WHOQOL)
Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)
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A 26-item self-report measure that assesses individuals' perceptions of their quality of life over the previous two weeks.
Each item is rated on a 5-point Likert scale reflecting satisfaction across various domains of life.
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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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Autism and Neurodiversity Attitudes Scale, ANAS
Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)
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This is a 17-item self-report scale that measures the degree of acceptance of the neurodiversity perspective on autism and related attitudes.
It assesses attitudes related to anti-stigma toward autism, the persistence of autism, and the view of autism as a difference.
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Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)
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Autism Spectrum Identity Scale, ASIS
Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)
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This is a 22-item self-report scale that assesses how individuals perceive their own autistic identity.
It measures multiple dimensions of autistic identity, including the extent to which autism is viewed as a positive difference, context-dependent identity perception, recognition of autism-related strengths, and the possibility of change.
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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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- 2025S1A5A8007553
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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