AutismCRUSHNCT07406100
Piloting the Competence in Romance and Understanding Sexual Health Curriculum
A study testing Competence in Romance and Understanding Sexual Health (CRUSH) in people with Autism and Autism Disorder, run by Boston Children's Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Autism, Autism Disorder, Autism Spectrum Disorder
- What is being tested?
- Competence in Romance and Understanding Sexual Health (CRUSH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18;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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital, Two Brookline Place
Brookline, Massachusetts, 02445
Susan Faja, PhD, 6179194108, ProjectCRUSH@childrens.harvard.edu
About this study
Official title: A Pilot Investigation of the Competence in Romance and Understanding Sexual Health Curriculum
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:
Read more
- 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.
Read the detailed description
There are currently no evidence-based interventions to improve the dating and sexual health of autistic adults. The CRUSH (Competence in Romance and Understanding Sexual Health) Curriculum was designed to address this critical gap, which was piloted with a small group of participants. This study is a pilot program of the CRUSH curriculum for 40 participants to acquire initial feasibility and acceptability data. It will also test the feasibility and acceptability of the measurement battery for potential inclusion in future clinical trials. 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), how it works (mechanism), 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
- Being tested
- Competence in Romance and Understanding Sexual Health (CRUSH)
- Keywords
- sexual health, romantic relationships
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Competence in Romance and Understanding Sexual Health (CRUSH)Behavioural
Manualized curriculum targeting sexual health and behavior in intimate relationships designed to meet the specific needs of autistic adults
| Study group | Role | What they receive |
|---|---|---|
| CRUSH Intervention | Experimental | Participants will receive the CRUSH Curriculum Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability Rating Scale
This is the primary acceptability outcome. Likert ratings with a 5-pt scale
Measured: 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.
Measured: 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.
Measured: At the Baseline, Midpoint (10-weeks), and Post-intervention (20-weeks) visits
Secondary outcomes (1)
Feasibility Assessment
Attrition rates; Missing data rates for assessment instruments
Measured: Within one day of each intervention session and at the Baseline, Midpoint (10 weeks), and Post-intervention visit (20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Apr 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Faja, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406100
- Sponsor's protocol ID
- FP01037275
- Other IDs
- 2009
- Acronym
- CRUSH
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Investigation of the Competence in Romance and Understanding Sexual Health Curriculum
- ClinicalTrials.gov ID
- NCT07406100
- Acronym / sponsor ID
- CRUSH / FP01037275
- Conditions
- Autism, Autism Disorder, Autism Spectrum Disorder
- Keywords
- sexual health, romantic relationships
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There are currently no evidence-based interventions to improve the dating and sexual health of autistic adults. The CRUSH (Competence in Romance and Understanding Sexual Health) Curriculum was designed to address this critical gap, which was piloted with a small group of participants. This study is a pilot program of the CRUSH curriculum for 40 participants to acquire initial feasibility and acceptability data. It will also test the feasibility and acceptability of the measurement battery for potential inclusion in future clinical trials. 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), how it works (mechanism), 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRUSH Intervention | Experimental | Behavioral: Competence in Romance and Understanding Sexual Health (CRUSH)Participants will receive the CRUSH Curriculum |
| Waitlist | No intervention | –Will be invited to receive the CRUSH intervention at the end of the study period |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18;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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | CRUSH Intervention |
Primary outcome
Acceptability Rating Scale
Time frame: Within one day of each intervention session and at the Baseline, Midpoint (10 weeks), and Post-intervention visit (20 weeks)
This is the primary acceptability outcome. Likert ratings with a 5-pt scale
Sexual Vocabulary Test - Pragmatics Total Score
Time frame: At the Baseline, Midpoint (10-weeks), and Post-intervention (20-weeks) visits
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.
Psychosexual Knowledge Test
Time frame: At the Baseline, Midpoint (10-weeks), and Post-intervention (20-weeks) visits
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.
1 secondary outcome
Feasibility Assessment
Time frame: Within one day of each intervention session and at the Baseline, Midpoint (10 weeks), and Post-intervention visit (20 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Competence in Romance and Understanding Sexual Health (CRUSH) in people with Autism and Autism Disorder, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Faja, PhD (6179194108, ProjectCRUSH@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability Rating Scale (time frame: Within one day of each intervention session and at the Baseline, Midpoint (10 weeks), and Post-intervention visit (20 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.