Clinical trial NCT05910658: First CRUSH: Piloting the Preliminary Feasibility and Acceptability of the Competence in Romance and Understanding Sexual Health (CRUSH) Curriculum
Official title: First CRUSH: Piloting the Preliminary Feasibility and Acceptability of the Competence in Romance and Understanding Sexual Health (CRUSH) Curriculum
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2023-06-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Acceptability Rating Scale
timeFrame: At baseline enrollment visit and weekly throughout training for a total of 20 weeks
Secondary outcomes:
measure: Feasibility Assessment
timeFrame: At baseline enrollment visit and weekly throughout training for a total of 20 weeks
Other outcomes:
measure: Sexual Vocabulary Test
timeFrame: At baseline enrollment visit; 8-10 weeks after beginning intervention (i.e., midpoint); 18-22 weeks after beginning intervention (i.e., post-testing)
measure: Mathtech Behavioral Scale
timeFrame: At baseline enrollment visit; 8-10 weeks after beginning intervention (i.e., midpoint); 18-22 weeks after beginning intervention (i.e., post-testing)
Locations:
city: Brookline
country: United States
facility: Boston Children's Hospital, Two Brookline Place
state: Massachusetts
Study officials:
References: