Development and Evaluation of a Sexuality and Relationship Education for Autistic Adults Using a SMART -Based Adaptive Intervention Approach
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Korean-Adolescents/Adults Sensory Profile (K-AASP)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Korean-Adolescents/Adults Sensory Profile (K-AASP)
时间窗: Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up).
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.
Psychosexual Knowledge Test (PKT)
时间窗: Time Frame: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up).
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
Perceived Knowledge Questionnaire (PKQ)
时间窗: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)
A 5-item self-report measure evaluating participants' perceived level of sexual health knowledge. Items are answered in a True/False format.
Korean Relationship and Sexuality Scale (KRSS)
时间窗: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)
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.
Self-Efficacy in Romantic Relationships Scale
时间窗: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)
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)
Sexual Desire Inventory-2 (SDI-2)
时间窗: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)
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).
Sexual and Dating Experiences Questionnaire
时间窗: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)
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.
Sexual Experience Questionnaire (SEQ)
时间窗: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)
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.
Survey of Sexual Attitudes and Sexual Behaviors Among Male and Female College Students, Including Graduate Students
时间窗: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)
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.
Dyadic Adjustment Scale, DAS
时间窗: Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up)
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.
次要结局
- Beck Anxiety Inventory (BAI)(Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up))
- 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))
- 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))
- Autism and Neurodiversity Attitudes Scale, ANAS(Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up))
- Autism Spectrum Identity Scale, ASIS(Baseline (pre-intervention), 1 week post-intervention, and 10 weeks post-intervention (follow-up))