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CompletedNCT05910658Updated Aug 13, 2026Results posted

First CRUSH: Piloting the Preliminary Feasibility and Acceptability of the Competence in Romance and Understanding Sexual Health (CRUSH) Curriculum

An interventional study of Competence in Romance and Understanding Sexual Health (CRUSH) in Autism and Autism Spectrum Disorder, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 30 Years
Sex
All
01

Study 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.
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.
02

Conditions studied

  • Autism
  • Autism Spectrum Disorder
03

In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

This study's enrollment of 8 is below the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Other
    Intervention Group

    Participants will receive the CRUSH Curriculum

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

Interventions

  • BehavioralCompetence 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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)

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

Other outcomes

  1. Sexual Vocabulary Test (Ousley & Mesibov, 1991; Kohn et al., 2022) - Vocabulary Accuracy and Pragmatics Scores

    A measure of 18 terms related to basic knowledge of sexual health and anatomy. The Vocabulary Accuracy score measures the ability to provide definitions of sexual health terms (knowledge) and is scored on a 3-point scale for accuracy: 2 for a detailed correct answer, 1 for a generally correct answer, and 0 for a response of "don't know" or an incorrect answer. The Pragmatics score measures sociocultural competence (slang), vulgarity, mechanical language, relevancy, strategic competence, and discourse competence. Pragmatics are scored scored on a scale of 0-2 with 0 representing the highest level of pragmatic skill and 2 represented the lowest score for each item. This test was used as a measure of target engagement. Partial eta squared effect size is for change over time (baseline, midpoint, post) modeled with repeated measures ANOVA.

    Time frame: At baseline enrollment visit; 8-10 weeks after beginning intervention (i.e., midpoint); 18-22 weeks after beginning intervention (i.e., post-testing). Effect sizes are for change across timepoints (i.e., trajectory from baseline to midpoint to post).

  2. Mathtech Behavioral Scale (Kirby, 2013)

    A measure of sexual health and intimate behavior to be used as a primary outcome in a future trial (higher scores indicate higher levels of behavior) measures possible outcomes of sexuality education programs including changes in behavior that facilitate a positive and fulfilling sexuality and sexual health and independent of relationship status. It includes 45 items that include the skill with which a behavior is completed, comfort during that behavior, and the frequency of the behavior; responses use a 5-point rating, a 4-point rating, and the frequency in the past month, respectively. Partial eta squared effect size is for change over time (baseline, midpoint, post) modeled with repeated measures ANOVA.

    Time frame: At baseline enrollment visit; 8-10 weeks after beginning intervention (i.e., midpoint); 18-22 weeks after beginning intervention (i.e., post-testing). Effect sizes are for change across timepoints (i.e., trajectory from baseline to midpoint to post).

07

Results

Posted Aug 13, 2026

Participant flow

Participant flow — Overall Study
MilestoneIntervention Group
Started8
Completed8
Not completed0

Outcome measures

PrimaryAcceptability 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.

Time frame:
At baseline enrollment visit and weekly throughout training for a total of 20 weeks
Reported as:
Mean · Units on a 5-point rating scale
Acceptability Rating Scale
Units on a 5-point rating scaleIntervention Group
Acceptability Rating Scale1.301886792 ± 0.503255007
SecondaryFeasibility Assessment

Analysis of missing items or session content that cannot be completed (fewer missing items indicates better feasibility)

Time frame:
At baseline enrollment visit and weekly throughout training for a total of 20 weeks
Reported as:
Count of participants · Participants
Feasibility Assessment
ParticipantsIntervention Group
Feasibility Assessment8
Statistical analysis
  • Intervention Group ·
Other pre-specifiedSexual Vocabulary Test (Ousley & Mesibov, 1991; Kohn et al., 2022) - Vocabulary Accuracy and Pragmatics Scores

A measure of 18 terms related to basic knowledge of sexual health and anatomy. The Vocabulary Accuracy score measures the ability to provide definitions of sexual health terms (knowledge) and is scored on a 3-point scale for accuracy: 2 for a detailed correct answer, 1 for a generally correct answer, and 0 for a response of "don't know" or an incorrect answer. The Pragmatics score measures sociocultural competence (slang), vulgarity, mechanical language, relevancy, strategic competence, and discourse competence. Pragmatics are scored scored on a scale of 0-2 with 0 representing the highest level of pragmatic skill and 2 represented the lowest score for each item. This test was used as a measure of target engagement. Partial eta squared effect size is for change over time (baseline, midpoint, post) modeled with repeated measures ANOVA.

Time frame:
At baseline enrollment visit; 8-10 weeks after beginning intervention (i.e., midpoint); 18-22 weeks after beginning intervention (i.e., post-testing). Effect sizes are for change across timepoints (i.e., trajectory from baseline to midpoint to post).
Reported as:
Number · Partial eta squared (effect size)
Sexual Vocabulary Test (Ousley & Mesibov, 1991; Kohn et al., 2022) - Vocabulary Accuracy and Pragmatics Scores
Partial eta squared (effect size)Intervention Group
Pragmatic (slang)0.43
Accuracy (knowledge)0.15
Other pre-specifiedMathtech Behavioral Scale (Kirby, 2013)

A measure of sexual health and intimate behavior to be used as a primary outcome in a future trial (higher scores indicate higher levels of behavior) measures possible outcomes of sexuality education programs including changes in behavior that facilitate a positive and fulfilling sexuality and sexual health and independent of relationship status. It includes 45 items that include the skill with which a behavior is completed, comfort during that behavior, and the frequency of the behavior; responses use a 5-point rating, a 4-point rating, and the frequency in the past month, respectively. Partial eta squared effect size is for change over time (baseline, midpoint, post) modeled with repeated measures ANOVA.

Time frame:
At baseline enrollment visit; 8-10 weeks after beginning intervention (i.e., midpoint); 18-22 weeks after beginning intervention (i.e., post-testing). Effect sizes are for change across timepoints (i.e., trajectory from baseline to midpoint to post).
Reported as:
Number · Partial eta squared (effect size)
Mathtech Behavioral Scale (Kirby, 2013)
Partial eta squared (effect size)Intervention Group
Comfort having Current Sex Life (whatever it may be)0.16
Comfort Getting and Using Birth Control0.15
Comfort with being Sexually Assertive (more confidence saying "no")0.13
Sexual Decision-Making Skills (more efficient and collaborative sexual health decision making)0.06
Comfort Talking about Birth Control (with friends, partners, parents).222

Adverse events

Collected over At each intervention visit (20 weeks). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention Group0/8 (0%)0/8 (0%)0/8 (0%)

Baseline characteristics

Age, Customized
Age, Customized(Participants)Intervention Group
18-24 years4
25-304
Sex: Female, Male
Sex: Female, Male(Participants)Intervention Group
Female3
Male5
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Intervention Group
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American0
White4
More than one race3
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Intervention Group
United States8
08

Study locations

1 site
  • Boston Children's Hospital, Two Brookline Place
    Brookline, Massachusetts 02445, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 22, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05910658
Lead sponsor
Boston Children's Hospital
Collaborators
Children's Hospital of Philadelphia
Responsible party
Susan Faja (Associate Professor, Boston Children's Hospital) — Principal investigator
First posted
Jun 20, 2023
Start date
Jul 1, 2023
Primary completion
Jun 18, 2024
Completion
Jul 18, 2024
Results posted
Aug 13, 2026
Last update
Aug 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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