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Completed

NCT Number: NCT05910658

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

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital, Two Brookline Place

Brookline, Massachusetts, 02445, United States

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, 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Feasibility Assessment

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

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

Other outcomes

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

    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).

    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.

  2. Mathtech Behavioral Scale (Kirby, 2013)

    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).

    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.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Children's Hospital of Philadelphia

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 20, 2023
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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