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

NCT ID: NCT05910658

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-10-18

Brief Summary

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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

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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.

Conditions

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Autism Autism Spectrum Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention Group

Participants will receive the CRUSH Curriculum

Group Type OTHER

Competence in Romance and Understanding Sexual Health (CRUSH)

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Susan Faja

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Boston Children's Hospital, Two Brookline Place

Brookline, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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FP01030935

Identifier Type: -

Identifier Source: org_study_id

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