Autism, Autism Spectrum Disorder
Conditions
Brief 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.
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.
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
Children's Hospital of Philadelphia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability Rating Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Assessment | 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) |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 18-24 years | 4 Participants |
| Age, Customized 25-30 | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
None listed