NCT05910658

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 20, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2023

Enrollment Period

12 months

First QC Date

June 1, 2023

Last Update Submit

August 19, 2024

Conditions

AutismAutism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Feasibility Assessment

    At baseline enrollment visit and weekly throughout training for a total of 20 weeks

Other Outcomes (2)

  • 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)

  • 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)

Study Arms (1)

Intervention Group

OTHER

Participants will receive the CRUSH Curriculum

Behavioral: Competence in Romance and Understanding Sexual Health (CRUSH)

Interventions

Competence in Romance and Understanding Sexual Health (CRUSH)BEHAVIORAL

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

Intervention Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital, Two Brookline Place

Brookline, Massachusetts, 02445, United States

Location

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum Disorder

Interventions

Mental Competency

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

JurisprudenceSocial Control, FormalHealth Care Economics and Organizations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 20, 2023

Study Start

July 1, 2023

Primary Completion

June 18, 2024

Study Completion

October 18, 2024

Last Updated

August 21, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)