Piloting the Competence in Romance and Understanding Sexual Health Curriculum
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorBoston Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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);
Trial design
Design model
Crossover
Treatments tested in this trial
Competence in Romance and Understanding Sexual Health (CRUSH)
BehavioralManualized curriculum targeting sexual health and behavior in intimate relationships designed to meet the specific needs of autistic adults
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: CRUSH InterventionExperimental treatment 1 intervention
Group B: WaitlistNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Acceptability Rating Scale
This is the primary acceptability outcome. Likert ratings with a 5-pt scale
Time frame
Within one day of each intervention session and at the Baseline, Midpoint (10 weeks), and Post-intervention visit (20 weeks)2
Sexual Vocabulary Test - Pragmatics Total Score
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.
Time frame
At the Baseline, Midpoint (10-weeks), and Post-intervention (20-weeks) visits3
Psychosexual Knowledge Test
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.
Time frame
At the Baseline, Midpoint (10-weeks), and Post-intervention (20-weeks) visitsSecondary outcomes
1
Feasibility Assessment
Attrition rates; Missing data rates for assessment instruments
Time frame
Within one day of each intervention session and at the Baseline, Midpoint (10 weeks), and Post-intervention visit (20 weeks)Sponsors and contacts
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Source ClinicalTrials.gov