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

Sponsor
Boston Children's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05910658
Collaborator
Children's Hospital of Philadelphia (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Competence in Romance and Understanding Sexual Health (CRUSH)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
First CRUSH: Piloting the Preliminary Feasibility and Acceptability of the Competence in Romance and Understanding Sexual Health (CRUSH) Curriculum
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Acceptability Rating Scale [At baseline enrollment visit and weekly throughout training for a total of 20 weeks]

    A measure of the acceptability of methods used in the project including qualitative interview and 5-point rating scale (lower scores indicate higher acceptability)

Secondary Outcome Measures

  1. Feasibility Assessment [At baseline enrollment visit and weekly throughout training for a total of 20 weeks]

    Analysis of missing items or session content that cannot be completed (fewer missing items indicates better feasibility)

Other Outcome Measures

  1. Sexual Vocabulary Test [At baseline enrollment visit; 8-10 weeks after beginning intervention (i.e., midpoint); 18-22 weeks after beginning intervention (i.e., post-testing)]

    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)

  2. Mathtech Behavioral Scale [At baseline enrollment visit; 8-10 weeks after beginning intervention (i.e., midpoint); 18-22 weeks after beginning intervention (i.e., post-testing)]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boston Children's Hospital, Two Brookline Place Brookline Massachusetts United States 02445

Sponsors and Collaborators

  • Boston Children's Hospital
  • Children's Hospital of Philadelphia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Susan Faja, Associate Professor, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT05910658
Other Study ID Numbers:
  • FP01030935
First Posted:
Jun 20, 2023
Last Update Posted:
Jun 20, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 20, 2023