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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05910658
• Other study ID #: FP01030935
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: August 2023
• Source: Boston Children's Hospital
• Contact: Susan Faja, PhD
• Phone: 6179194486
• Email: susan.faja[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Boston Children's Hospital, Two Brookline Place	Brookline	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Primary	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	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