AutismNCT05910658
First CRUSH: Piloting the Preliminary Feasibility and Acceptability of the Competence in Romance and Understanding Sexual Health (CRUSH) Curriculum
A study testing Competence in Romance and Understanding Sexual Health (CRUSH) in people with Autism and Autism Spectrum Disorder, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Autism, 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
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 18 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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
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).
- Live more than 35 miles from Two Brookline Place, Brookline, MA where intervention sessions will be offered.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital, Two Brookline Place
Brookline, Massachusetts, 02445
About this study
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:
Read more
- 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.
Read the detailed description
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
- Autism, Autism Spectrum Disorder
- Being tested
- Competence in Romance and Understanding Sexual Health (CRUSH)
- 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 |
|---|---|---|
| Intervention Group | Other | Participants will receive the CRUSH Curriculum Receives: Behavioral: Competence in Romance and Understanding Sexual Health (CRUSH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability Rating Scale
A qualitative measure of the acceptability of intervention was collected at each timepoint. Quantitative acceptability ratings about the CRUSH curriculum were obtained at the conclusion of intervention using a 5-point rating scale, with "1" indicating agreement with a statement about the curriculum and "5" indicating disagreement. Items were: I would be likely to recommend the program to a friend. Knowing what I know now, I'm happy with my choice to participate in the CRUSH Program. The program was easy to understand. The CRUSH Program presented information clearly. The program was relevant to me and my experience. The program was helpful. I learned new information from the program. I feel more confident in my ability try new things in relationships or sexual experiences after participating in the program. I have new skills/behaviors after participating in the program. Items were averaged into a total score (range: 1-5); lower scores reflected higher agreement/better acceptability.
Measured: At baseline enrollment visit and weekly throughout training for a total of 20 weeks
Secondary outcomes (1)
Feasibility Assessment
Analysis of missing items or session content that cannot be completed (fewer missing items indicates better feasibility)
Measured: At baseline enrollment visit and weekly throughout training for a total of 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start1 Jul 2023
- Primary completion18 Jun 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Principal investigator, Susan Faja, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910658
- Sponsor's protocol ID
- FP01030935
- Status last verified
- May 2026
- First submitted
- 1 Jun 2023
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First CRUSH: Piloting the Preliminary Feasibility and Acceptability of the Competence in Romance and Understanding Sexual Health (CRUSH) Curriculum
- ClinicalTrials.gov ID
- NCT05910658
- Acronym / sponsor ID
- FP01030935
- Conditions
- Autism, Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 20 Jun 2023 (actual)
- Results
- Posted 13 Aug 2026
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 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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Other | Behavioral: Competence in Romance and Understanding Sexual Health (CRUSH)Participants will receive the CRUSH Curriculum |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 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).
- Live more than 35 miles from Two Brookline Place, Brookline, MA where intervention sessions will be offered.
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 | Intervention Group |
Primary outcome
Acceptability Rating Scale
Time frame: At baseline enrollment visit and weekly throughout training for a total of 20 weeks
A qualitative measure of the acceptability of intervention was collected at each timepoint. Quantitative acceptability ratings about the CRUSH curriculum were obtained at the conclusion of intervention using a 5-point rating scale, with "1" indicating agreement with a statement about the curriculum and "5" indicating disagreement. Items were: I would be likely to recommend the program to a friend. Knowing what I know now, I'm happy with my choice to participate in the CRUSH Program. The program was easy to understand. The CRUSH Program presented information clearly. The program was relevant to me and my experience. The program was helpful. I learned new information from the program. I feel more confident in my ability try new things in relationships or sexual experiences after participating in the program. I have new skills/behaviors after participating in the program. Items were averaged into a total score (range: 1-5); lower scores reflected higher agreement/better acceptability.
1 secondary outcome
Feasibility Assessment
Time frame: At baseline enrollment visit and weekly throughout training for a total of 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Spectrum 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 4 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: finished, as of the sponsor's last update on 13 Aug 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?
Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability Rating Scale (time frame: At baseline enrollment visit and weekly throughout training for a total of 20 weeks). 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 13 Aug 2026.