Boston Children's Hospital, Two Brookline Place
Brookline, Massachusetts, 02445, United States
Location status: Recruiting
NCT Number: NCT07406100
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.
Interested in participating?
Request Info18 year–30 year
All sexes
Interventional
Not applicable
Brookline, Massachusetts, 02445, United States
Location status: Recruiting
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:
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: 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
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.
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.
Time frame: Within one day of each intervention session and at the Baseline, Midpoint (10 weeks), and Post-intervention visit (20 weeks)
Attrition rates; Missing data rates for assessment instruments
Contact information is provided by the study sponsor or research team.
Boston Children's Hospital
Other
A Pilot Investigation of the Competence in Romance and Understanding Sexual Health Curriculum
Acronym: CRUSH
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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