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

NCT05910658 | Completed Results

• 1 other identifier: FP01030935
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Acceptability Rating Scale

  A qualitative measure of the acceptability of intervention was collected at each timepoint. Quantitative acceptability ratings about the CRUSH curriculum were obtained at the conclusion of intervention using a 5-point rating scale, with "1" indicating agreement with a statement about the curriculum and "5" indicating disagreement. Items were: I would be likely to recommend the program to a friend. Knowing what I know now, I'm happy with my choice to participate in the CRUSH Program. The program was easy to understand. The CRUSH Program presented information clearly. The program was relevant to me and my experience. The program was helpful. I learned new information from the program. I feel more confident in my ability try new things in relationships or sexual experiences after participating in the program. I have new skills/behaviors after participating in the program. Items were averaged into a total score (range: 1-5); lower scores reflected higher agreement/better acceptability.

  At baseline enrollment visit and weekly throughout training for a total of 20 weeks

Secondary Outcomes (1)

• Feasibility Assessment

  At baseline enrollment visit and weekly throughout training for a total of 20 weeks

Other Outcomes (2)

• Sexual Vocabulary Test (Ousley & Mesibov, 1991; Kohn et al., 2022) - Vocabulary Accuracy and Pragmatics Scores

  At baseline enrollment visit; 8-10 weeks after beginning intervention (i.e., midpoint); 18-22 weeks after beginning intervention (i.e., post-testing). Effect sizes are for change across timepoints (i.e., trajectory from baseline to midpoint to post).

• Mathtech Behavioral Scale (Kirby, 2013)

  At baseline enrollment visit; 8-10 weeks after beginning intervention (i.e., midpoint); 18-22 weeks after beginning intervention (i.e., post-testing). Effect sizes are for change across timepoints (i.e., trajectory from baseline to midpoint to post).

Study Arms (1)

Intervention Group

OTHER

Participants will receive the CRUSH Curriculum

Behavioral: Competence in Romance and Understanding Sexual Health (CRUSH)

Interventions

Competence in Romance and Understanding Sexual Health (CRUSH) BEHAVIORAL

Manualized curriculum targeting sexual health and behavior in intimate relationships designed to meet the specific needs of autistic adults

Intervention Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

Boston Children's Hospital, Two Brookline Place

Brookline, Massachusetts, 02445, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Interventions

Mental Competency

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Jurisprudence; Social Control, Formal; Health Care Economics and Organizations

Results Point of Contact

• Title: Susan Faja
• Organization: Boston Children's Hospital / Harvard Medical School

susan.faja@childrens.harvard.edu

6179194486

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 20, 2023
• Study Start: July 1, 2023
• Primary Completion: June 18, 2024
• Study Completion: July 18, 2024
• Last Updated: August 13, 2026
• Results First Posted: August 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)