NCT07728864

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
21mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress11%
Jul 2026May 2028

First Submitted

Initial submission to the registry

July 22, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

1.7 years

First QC Date

July 22, 2026

Last Update Submit

July 22, 2026

Conditions

Keywords

ASD, Adult, Sex and relationship education, CBPR

Outcome Measures

Primary Outcomes (10)

  • Korean-Adolescents/Adults Sensory Profile (K-AASP)

    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.

    Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up).

  • Psychosexual Knowledge Test (PKT)

    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

    Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up).

  • Perceived Knowledge Questionnaire (PKQ)

    A 5-item self-report measure evaluating participants' perceived level of sexual health knowledge. Items are answered in a True/False format.

    Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)

  • Korean Relationship and Sexuality Scale (KRSS)

    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.

    Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)

  • Self-Efficacy in Romantic Relationships Scale

    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)

    Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)

  • Sexual Desire Inventory-2 (SDI-2)

    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).

    Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)

  • Sexual and Dating Experiences Questionnaire

    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.

    Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)

  • Sexual Experience Questionnaire (SEQ)

    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.

    Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)

  • Survey of Sexual Attitudes and Sexual Behaviors Among Male and Female College Students, Including Graduate Students

    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.

    Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)

  • Dyadic Adjustment Scale, DAS

    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.

    Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)

Secondary Outcomes (7)

  • Beck Depression Inventory (BDI)

    Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)

  • Camouflaging Autistic Traits Questionnaire (CAT-Q)

    Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)

  • Beck Anxiety Inventory (BAI)

    Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)

  • The Korean version of the World Health Organization Quality of Life scale (WHOQOL)

    Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)

  • Relationships, Employment, Autonomy, and Life Satisfaction Scale (REALS)

    Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)

  • +2 more secondary outcomes

Study Arms (2)

Web-Based Learning

EXPERIMENTAL

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.

Behavioral: Web-Based Sex and Relationship EducationBehavioral: Group Coaching Sessions

Web-Based Learning Plus Group Coaching

EXPERIMENTAL

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.

Behavioral: Web-Based Sex and Relationship EducationBehavioral: Group Coaching SessionsBehavioral: Individual Coaching

Interventions

Participants complete individual learning modules through a web-based sex and relationship education portal developed for autistic adults.

Web-Based LearningWeb-Based Learning Plus Group Coaching

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.

Web-Based LearningWeb-Based Learning Plus Group Coaching

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.

Web-Based Learning Plus Group Coaching

Eligibility Criteria

Age18 Years - 40 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ewha Womans University

Seoul, South Korea

Location

MeSH Terms

Conditions

Autism Spectrum DisorderCoitus

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSexual BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2026

First Posted

July 27, 2026

Study Start

July 22, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

May 31, 2028

Last Updated

July 27, 2026

Record last verified: 2026-07

Locations