Piloting the Competence in Romance and Understanding Sexual Health Curriculum

Официальное название

A Pilot Investigation of the Competence in Romance and Understanding Sexual Health Curriculum

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Competence in Romance and Understanding Sexual Health (CRUSH)
  Manualized curriculum targeting sexual health and behavior in intimate relationships designed to meet the specific needs of autistic adults

Первичные конечные точки

• Acceptability Rating Scale [Срок оценки: Within one day of each intervention session and at the Baseline, Midpoint (10 weeks), and Post-intervention visit (20 weeks)]
• Sexual Vocabulary Test - Pragmatics Total Score [Срок оценки: At the Baseline, Midpoint (10-weeks), and Post-intervention (20-weeks) visits]
• Psychosexual Knowledge Test [Срок оценки: At the Baseline, Midpoint (10-weeks), and Post-intervention (20-weeks) visits]

Вторичные конечные точки (1)

• Feasibility Assessment [Срок оценки: Within one day of each intervention session and at the Baseline, Midpoint (10 weeks), and Post-intervention visit (20 weeks)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Boston Children's Hospital, Two Brookline Place — Brookline

Идентификаторы

NCT: NCT07406100 · FP01037275 · 2009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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