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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Autism Spectrum Disorder; Autism
• Intervention / Treatment: Behavioral: Competence in Romance and Understanding Sexual Health (CRUSH)

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Brookline, Massachusetts, United States, 02445
      • Boston Children's Hospital, Two Brookline Place

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention Group; Participants will receive the CRUSH Curriculum	Behavioral: 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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual Vocabulary Test	A measure of the ability to provide definitions of sexual health terms to be used as a measure of target engagement (higher score indicates higher level of knowledge)	At baseline enrollment visit; 8-10 weeks after beginning intervention (i.e., midpoint); 18-22 weeks after beginning intervention (i.e., post-testing)
Mathtech Behavioral Scale	A measure of sexual health and intimate behavior to be used as a primary outcome in a future trial (higher scores indicate higher levels of behavior)	At baseline enrollment visit; 8-10 weeks after beginning intervention (i.e., midpoint); 18-22 weeks after beginning intervention (i.e., post-testing)

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): June 18, 2024
• Study Completion (Estimated): October 18, 2024

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 20, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: FP01030935

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No