CRUSH Curriculum for Autism

(CRUSH Trial)

Overseen By Susan Faja, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Non-English, Genetic ASD, Major mental illness, Medical conditions, Sensory/motor/physical conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn whether the CRUSH curriculum is possible (feasible), whether it fits the needs of the adults it is designed for (acceptable), and shows initial signs of being helpful (efficacious). CRUSH is a group-based behavioral intervention plus 1-1 coaching designed to provide sexual education and improve the skills of autistic adults for intimate relationships.

The main goals of the project are to:

* Evaluate the feasibility and acceptability of the CRUSH curriculum in the context of a clinical trial with a waitlist control condition.

* Initial exploration of how the CRUSH curriculum works and whether it is helpful.

Participants will complete:

* A screening call.

* Confirmation of clinical characteristics (autism features, language ability, cognitive ability).

* 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).

* 20 sessions of the CRUSH curriculum plus 1-1 coaching sessions. After each session, provide feedback about the session.

Are You a Good Fit for This Trial?

This trial is for adults with Autism Spectrum Disorder who are interested in improving their intimate relationship skills. They should be able to communicate and participate in a group setting, as well as provide feedback after sessions.

Inclusion Criteria

Fluent in English

I am between 18 and 30 years old.

Ability to provide consent for the protocol and understand task demands. The Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-2) may be used to confirm cognitive level. In prior work, adults with a full-scale IQ of 70 or above on the WASI-2 typically meet this criterion, but a licensed clinician will review individuals who fall below an IQ of 70 on an individual basis to determine eligibility

Exclusion Criteria

Major mental illness (e.g., bipolar disorder, schizophrenia, or psychosis)

I primarily speak a language other than English.

My ASD is due to a known genetic reason like Fragile X.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual)

Baseline Assessment

Participants complete baseline assessments of knowledge and behaviors related to dating and sexual health

1 week

1 visit (in-person)

Treatment

Participants undergo 20 sessions of the CRUSH curriculum plus 1-1 coaching sessions

20 weeks

20 sessions (in-person)

Midpoint Assessment

Participants are assessed midway through the intervention to evaluate progress

1 week

1 visit (in-person)

Post-intervention Assessment

Participants complete post-intervention assessments to evaluate the effectiveness of the CRUSH curriculum

1 week

1 visit (in-person)

Follow-up

Participants are monitored for long-term effects and retention of knowledge and skills

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Competence in Romance and Understanding Sexual Health (CRUSH)

Trial Overview

The CRUSH curriculum, which includes group-based behavioral intervention and one-on-one coaching aimed at sexual education and enhancing relationship skills for autistic adults, is being tested against a waitlist control.

How Is the Trial Designed?

Group I: CRUSH Intervention Experimental Treatment 1 Intervention

Participants will receive the CRUSH Curriculum

Group II: Waitlist Active Control 1 Intervention

Will be invited to receive the CRUSH intervention at the end of the study period

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+