First CRUSH: Piloting the Preliminary Feasibility and Acceptability of the Competence in Romance and Understanding Sexual Health (CRUSH) Curriculum

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to learn about the feasibility and acceptability of a behavioral intervention in designed to provide sexual education and improve the behavioral skills of autistic adults for intimate relationships. The main questions it aims to answer are: Acquire feasibility and acceptability data for delivery of the CRUSH curriculum in a group didactic setting plus 1-1 coaching. Acquire feasibility and acceptability data regarding the assessment battery for future clinical trials. Participants will complete: A screening call. Provide documentation of a diagnosis of autism spectrum disorder. 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). 15-20 training sessions to participate in the CRUSH curriculum. After each session, provide feedback about the session.

Detailed Description
-----------------
The goal of this clinical trial is to learn about the feasibility and acceptability of a behavioral intervention in designed to provide sexual education and improve the behavioral skills of autistic adults for intimate relationships, called CRUSH. The main questions it aims to answer are: Acquire feasibility and acceptability data for delivery of the CRUSH curriculum in a group didactic setting plus 1-1 coaching. Acquire feasibility and acceptability data regarding the assessment battery for future clinical trials. Participants will complete: A screening call. Provide documentation of a diagnosis of autism spectrum disorder. 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). 15-20 training sessions to participate in the CRUSH curriculum. After each session, provide feedback about the session.

Official Title
-----------------
First CRUSH: Piloting the Preliminary Feasibility and Acceptability of the Competence in Romance and Understanding Sexual Health (CRUSH) Curriculum

Conditions
-----------------
Autism, Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Behavioral: Competence in Romance and Understanding Sexual Health (CRUSH)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 30 years old; Documentation of a prior diagnosis of autism spectrum disorder (ASD) or receipt of services based on an ASD diagnosis; Ability to provide consent for the protocol and understand task demands (i.e., approximately WASI-2 full scale IQ of 70 or above); 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). Live more than 35 miles from Two Brookline Place, Brookline, MA where intervention sessions will be offered.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention Group<br>Participants will receive the CRUSH Curriculum | Behavioral: Competence in Romance and Understanding Sexual Health (CRUSH)<br>* Manualized curriculum targeting sexual health and behavior in intimate relationships designed to meet the specific needs of autistic adults<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability Rating Scale | A measure of the acceptability of methods used in the project including qualitative interview and 5-point rating scale (lower scores indicate higher acceptability) | At baseline enrollment visit and weekly throughout training for a total of 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility Assessment | Analysis of missing items or session content that cannot be completed (fewer missing items indicates better feasibility) | At baseline enrollment visit and weekly throughout training for a total of 20 weeks |