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

Primary Purpose

Autism, Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Competence in Romance and Understanding Sexual Health (CRUSH)
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Autism

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston Children's Hospital, Two Brookline PlaceRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention Group

Arm Description

Participants will receive the CRUSH Curriculum

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
June 1, 2023
Last Updated
August 30, 2023
Sponsor
Boston Children's Hospital
Collaborators
Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT05910658
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
Children's Hospital of Philadelphia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Autism Spectrum Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Other
Arm Description
Participants will receive the CRUSH Curriculum
Intervention Type
Behavioral
Intervention Name(s)
Competence in Romance and Understanding Sexual Health (CRUSH)
Intervention Description
Manualized curriculum targeting sexual health and behavior in intimate relationships designed to meet the specific needs of autistic adults
Primary Outcome Measure Information:
Title
Acceptability Rating Scale
Description
A measure of the acceptability of methods used in the project including qualitative interview and 5-point rating scale (lower scores indicate higher acceptability)
Time Frame
At baseline enrollment visit and weekly throughout training for a total of 20 weeks
Secondary Outcome Measure Information:
Title
Feasibility Assessment
Description
Analysis of missing items or session content that cannot be completed (fewer missing items indicates better feasibility)
Time Frame
At baseline enrollment visit and weekly throughout training for a total of 20 weeks
Other Pre-specified Outcome Measures:
Title
Sexual Vocabulary Test
Description
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)
Time Frame
At baseline enrollment visit; 8-10 weeks after beginning intervention (i.e., midpoint); 18-22 weeks after beginning intervention (i.e., post-testing)
Title
Mathtech Behavioral Scale
Description
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)
Time Frame
At baseline enrollment visit; 8-10 weeks after beginning intervention (i.e., midpoint); 18-22 weeks after beginning intervention (i.e., post-testing)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Faja, PhD
Phone
6179194486
Email
susan.faja@childrens.harvard.edu
Facility Information:
Facility Name
Boston Children's Hospital, Two Brookline Place
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Faja, PhD
Phone
617-919-4486
Email
susan.faja@childrens.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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