Piloting the Competence in Romance and Understanding Sexual Health Curriculum

NCT07406100 | Recruiting

• 2 other identifiers: FP010372752009
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism; Autism Disorder; Autism Spectrum Disorder

Keywords

sexual health; romantic relationships

Outcome Measures

Primary Outcomes (3)

• Acceptability Rating Scale

  This is the primary acceptability outcome. Likert ratings with a 5-pt scale

  Within one day of each intervention session and at the Baseline, Midpoint (10 weeks), and Post-intervention visit (20 weeks)

• Sexual Vocabulary Test - Pragmatics Total Score

  This is the primary measure of target engagement. A measure of the ability to provide definitions of sexual health terms to be used as a measure of target engagement - the primary dependent variable measures pragmatic language (e.g., slang) when discussing sexual health terms. Accuracy (knowledge of sexual health terms) is also collected as a secondary variable.

  At the Baseline, Midpoint (10-weeks), and Post-intervention (20-weeks) visits

• Psychosexual Knowledge Test

  This is the primary clinical outcome measure and assesses changes in the information participants have. This task was adapted for the first RCT of a sexual health curriculum developed for autistic adolescents to assess changes in information. It includes 35 multiple choice and 2 open-ended items that are scored as correct or incorrect.

  At the Baseline, Midpoint (10-weeks), and Post-intervention (20-weeks) visits

Secondary Outcomes (1)

• Feasibility Assessment

  Within one day of each intervention session and at the Baseline, Midpoint (10 weeks), and Post-intervention visit (20 weeks)

Study Arms (2)

CRUSH Intervention

EXPERIMENTAL

Participants will receive the CRUSH Curriculum

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

Waitlist

NO INTERVENTION

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

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

CRUSH Intervention

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ;0 to 30;11 years old;
• Either documentation of a prior diagnosis of autism spectrum disorder or receipt of services based on an autism spectrum diagnosis OR self identification as being autistic / on the autism spectrum and meeting the clinical cut-off on either the Autism Diagnostic Observation Schedule or the Autism Spectrum Quotient;
• 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 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;
• 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);
• Medical conditions that impact sexual function (e.g., pituitary tumor);
• Significant sensory, motor, or physical conditions that would prevent valid participation in assessments or intervention;
• Live more than 50 miles from the site in Brookline, MA where intervention and assessment sessions will be offered.
• Receipt of other sexual health/dating curricula as an adult.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital, Two Brookline Place

Brookline, Massachusetts, 02445, United States

RECRUITING

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Interventions

Mental Competency

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Jurisprudence; Social Control, Formal; Health Care Economics and Organizations

Central Study Contacts

Susan Faja, PhD

CONTACT

6179194108; ProjectCRUSH@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)