Aut-CARE program to improve thinking and emotional skills in young adults with autism
Co-creation of the Aut-CARE Intervention to Improve the Cognitive and Emotional Functioning of Young Adults on the Autism Spectrum and Facilitate Their Socio-occupational Integration
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · NCT07041502
This project will test a co-created Aut-CARE program to help 16–30-year-olds with autism improve emotional regulation and executive (thinking) skills to better manage school and work.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 37 (estimated) |
| Ages | 16 Years to 30 Years |
| Sex | All |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (other) |
| Locations | 1 site (Barcelona, Catalonia) |
| Trial ID | NCT07041502 on ClinicalTrials.gov |
What this trial studies
The study uses a mixed sequential design (quantitative → qualitative → quantitative) delivered at the Friends Foundation in Barcelona. Part A will quantitatively map socio-occupational, neuropsychological, and psychological variables in about 37 participants to relate impairment to integration outcomes. Part B will run focus groups (minimum 14 participants) to co-create the Aut-CARE intervention content with users and staff. Part C is a pilot with up to 10 participants to test the program's format, feasibility, acceptability, and preliminary signals of change using objective and subjective measures.
Who should consider this trial
Good fit: People aged 16 to 30 with DSM-5 autism spectrum disorder (levels 1 or 2), IQ > 80, who attend one or more services of the Friends Foundation are the intended participants.
Not a fit: Individuals outside the 16–30 age range, those with level 3 autism or intellectual disability (IQ ≤ 80), or those not engaged with Friends Foundation services are unlikely to benefit from this specific program.
Why it matters
Potential benefit: If successful, the Aut-CARE program could improve emotional regulation and executive functioning and thereby enhance participation in education and employment for young autistic adults.
How similar studies have performed: Related cognitive remediation and emotion-regulation programs for autistic adults have shown modest benefits, but a co-created Aut-CARE approach combining objective assessments and participatory design is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects aged 16 to 30 years (male, female, and non-binary) * Attending one or more services of the Friends Foundation (Prelaboral Friends, Laboral Friends, and EducaFriends). * Diagnosed with ASD (according to DSM-5 criteria), levels 1 or 2, and without intellectual disability (IQ \> 80). Exclusion Criteria: * None
Where this trial is running
Barcelona, Catalonia
- Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau — Barcelona, Catalonia, Spain (RECRUITING)
Study contacts
- Study coordinator: Alejandra Espinosa
- Email: AEspinosaG@santpau.cat
- Phone: +34 93 553 78 13
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autism Spectrum Disorder, Autism Spectrum Disorder With Absence of Functional Language