- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07406100
Piloting the Competence in Romance and Understanding Sexual Health Curriculum (CRUSH)
A Pilot Investigation of the Competence in Romance and Understanding Sexual Health Curriculum
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Susan Faja, PhD
- Phone Number: 6179194108
- Email: ProjectCRUSH@childrens.harvard.edu
Study Locations
-
-
Massachusetts
-
Brookline, Massachusetts, United States, 02445
- Recruiting
- Boston Children's Hospital, Two Brookline Place
-
Contact:
- Susan Faja, PhD
- Phone Number: 6179194108
- Email: ProjectCRUSH@childrens.harvard.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CRUSH Intervention
Participants will receive the CRUSH Curriculum
|
Manualized curriculum targeting sexual health and behavior in intimate relationships designed to meet the specific needs of autistic adults
|
|
No Intervention: Waitlist
Will be invited to receive the CRUSH intervention at the end of the study period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability Rating Scale
Time Frame: 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
|
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
Time Frame: 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.
|
At the Baseline, Midpoint (10-weeks), and Post-intervention (20-weeks) visits
|
|
Psychosexual Knowledge Test
Time Frame: 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.
|
At the Baseline, Midpoint (10-weeks), and Post-intervention (20-weeks) visits
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility Assessment
Time Frame: Within one day of each intervention session and at the Baseline, Midpoint (10 weeks), and Post-intervention visit (20 weeks)
|
Attrition rates; Missing data rates for assessment instruments
|
Within one day of each intervention session and at the Baseline, Midpoint (10 weeks), and Post-intervention visit (20 weeks)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FP01037275
- 2009 (Organization for Autism Research)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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