A Pilot Investigation of the Competence in Romance and Understanding Sexual Health Curriculum
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Acceptability Rating Scale
研究概览
简要总结
The goal of this clinical trial is to learn whether the CRUSH curriculum is possible (feasible), whether it fits the needs of the adults it is designed for (acceptable), and shows initial signs of being helpful (efficacious). CRUSH is a group-based behavioral intervention plus 1-1 coaching designed to provide sexual education and improve the skills of autistic adults for intimate relationships.
The main goals of the project are to:
- Evaluate the feasibility and acceptability of the CRUSH curriculum in the context of a clinical trial with a waitlist control condition.
- Initial exploration of how the CRUSH curriculum works and whether it is helpful.
Participants will complete:
- A screening call.
- Confirmation of clinical characteristics (autism features, language ability, cognitive ability).
- 3 visits to assess knowledge and behaviors related to dating and sexual health at each point throughout the training curriculum (before beginning, midway, and after finishing).
- 20 sessions of the CRUSH curriculum plus 1-1 coaching sessions. After each session, provide feedback about the session.
详细描述
There are currently no evidence-based interventions to improve the dating and sexual health of autistic adults. The CRUSH (Competence in Romance and Understanding Sexual Health) Curriculum was designed to address this critical gap, which was piloted with a small group of participants. This study is a pilot program of the CRUSH curriculum for 40 participants to acquire initial feasibility and acceptability data. It will also test the feasibility and acceptability of the measurement battery for potential inclusion in future clinical trials. The goal of this clinical trial is to learn whether the CRUSH curriculum is possible (feasible), whether it fits the needs of the adults it is designed for (acceptable), how it works (mechanism), and shows initial signs of being helpful (efficacious). CRUSH is a group-based behavioral intervention plus 1-1 coaching designed to provide sexual education and improve the skills of autistic adults for intimate relationships.
The main goals of the project are to:
- Evaluate the feasibility and acceptability of the CRUSH curriculum in the context of a clinical trial with a waitlist control condition.
- Initial exploration of how the CRUSH curriculum works and whether it is helpful.
Participants will complete:
- A screening call.
- Confirmation of clinical characteristics (autism features, language ability, cognitive ability).
- 3 visits to assess knowledge and behaviors related to dating and sexual health at each point throughout the training curriculum (before beginning, midway, and after finishing).
- 20 sessions of the CRUSH curriculum plus 1-1 coaching sessions. After each session, provide feedback about the session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18;0 to 30;11 years old;
- •Either documentation of a prior diagnosis of autism spectrum disorder or receipt of services based on an autism spectrum diagnosis OR self identification as being autistic / on the autism spectrum and meeting the clinical cut-off on either the Autism Diagnostic Observation Schedule or the Autism Spectrum Quotient;
- •Ability to provide consent for the protocol and understand task demands. The Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-2) may be used to confirm cognitive level. In prior work, adults with full scale IQ of 70 or above on the WASI-2 typically meet this criterion, but a licensed clinician will review individuals who fall below an IQ of 70 on an individual basis to determine eligibility;
- •Fluent in English.
排除标准
- •Non-English-speaking participants (less than 50% of speech in English);
- •Known genetic etiology of ASD (e.g., Fragile X);
- •Major mental illness (e.g., bipolar disorder, schizophrenia, or psychosis);
- •Medical conditions that impact sexual function (e.g., pituitary tumor);
- •Significant sensory, motor, or physical conditions that would prevent valid participation in assessments or intervention;
- •Live more than 50 miles from the site in Brookline, MA where intervention and assessment sessions will be offered.
- •Receipt of other sexual health/dating curricula as an adult.
研究组 & 干预措施
CRUSH Intervention
Participants will receive the CRUSH Curriculum
干预措施: Competence in Romance and Understanding Sexual Health (CRUSH) (Behavioral)
Waitlist
Will be invited to receive the CRUSH intervention at the end of the study period
结局指标
主要结局
Acceptability Rating Scale
时间窗: Within one day of each intervention session and at the Baseline, Midpoint (10 weeks), and Post-intervention visit (20 weeks)
This is the primary acceptability outcome. Likert ratings with a 5-pt scale
Sexual Vocabulary Test - Pragmatics Total Score
时间窗: At the Baseline, Midpoint (10-weeks), and Post-intervention (20-weeks) visits
This is the primary measure of target engagement. A measure of the ability to provide definitions of sexual health terms to be used as a measure of target engagement - the primary dependent variable measures pragmatic language (e.g., slang) when discussing sexual health terms. Accuracy (knowledge of sexual health terms) is also collected as a secondary variable.
Psychosexual Knowledge Test
时间窗: At the Baseline, Midpoint (10-weeks), and Post-intervention (20-weeks) visits
This is the primary clinical outcome measure and assesses changes in the information participants have. This task was adapted for the first RCT of a sexual health curriculum developed for autistic adolescents to assess changes in information. It includes 35 multiple choice and 2 open-ended items that are scored as correct or incorrect.
次要结局
- Feasibility Assessment(Within one day of each intervention session and at the Baseline, Midpoint (10 weeks), and Post-intervention visit (20 weeks))
研究者
Susan Faja
Associate Professor
Boston Children's Hospital