Boston Children's Hospital, Two Brookline Place
Brookline, Massachusetts, 02445, United States
NCT Number: NCT05910658
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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Notify Me18 year–30 year
All sexes
Interventional
Not applicable
Brookline, Massachusetts, 02445, United States
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:
Participants will complete:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Manualized curriculum targeting sexual health and behavior in intimate relationships designed to meet the specific needs of autistic adults
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.
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)
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.
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.
Boston Children's Hospital
Other
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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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