Autism, Autism Disorder, Autism Spectrum Disorder
Conditions
Keywords
sexual health, romantic relationships
Brief summary
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.
Detailed description
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: * 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.
Interventions
Manualized curriculum targeting sexual health and behavior in intimate relationships designed to meet the specific needs of autistic adults
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* 18;0 to 30;11 years old; * Either documentation of a prior diagnosis of autism spectrum disorder or receipt of services based on an autism spectrum diagnosis OR self identification as being autistic / on the autism spectrum and meeting the clinical cut-off on either the Autism Diagnostic Observation Schedule or the Autism Spectrum Quotient; * Ability to provide consent for the protocol and understand task demands. The Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-2) may be used to confirm cognitive level. In prior work, adults with full scale IQ of 70 or above on the WASI-2 typically meet this criterion, but a licensed clinician will review individuals who fall below an IQ of 70 on an individual basis to determine eligibility; * 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); * Medical conditions that impact sexual function (e.g., pituitary tumor); * Significant sensory, motor, or physical conditions that would prevent valid participation in assessments or intervention; * Live more than 50 miles from the site in Brookline, MA where intervention and assessment sessions will be offered. * Receipt of other sexual health/dating curricula as an adult.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability Rating Scale | 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 |
| Sexual Vocabulary Test - Pragmatics Total Score | 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. |
| Psychosexual Knowledge Test | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Assessment | 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 |
Countries
United States
Contacts
CONTACTSusan Faja, PhD
Outcome results
None listed