Aut-CARE Intervention to Improve Cognitive and Emotional Functioning in Young Adults on the Autism Spectrum

NCT ID: NCT07041502

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-16
• Study Completion Date: 2026-09-15

Brief Summary

Currently, many autistic youths struggle to adapt to academic programs or the workforce, often turning to third-sector organizations such as specialized associations and foundations. This may be due to factors such as emotional dysregulation and executive dysfunction, which interfere with their psychosocial adaptation abilities, leading to anxiety and depression. These challenges have a neurobiological basis tied to the unique complexities of the autistic brain, which experiences emotional and cognitive overload and lacks attentional filters. To address this issue, the emotional and executive functioning of autistic youths at the Friends Foundation will be assessed through objective and subjective assessments.

This data collection will serve as a foundation for conceptualizing and co-creating a more realistic affective-cognitive remediation program, integrating user perspectives (conceptualization of interventions for systematic implementation). The program aims to improve the socio-occupational and emotional adaptation difficulties that often contribute to mental health challenges within this underserved population. It is important to highlight that many existing programs focus on cognitive training and social skills, neglecting strategies for adaptation and emotional regulation. This project will stand out for its inclusive design, featuring a representative sample of both sexes, overcoming the usual limitation of male-centered approaches.

Detailed Description

The mixed or hybrid sequential study design (quantitative → qualitative → quantitative) includes three parts:

A) Assessment of socio-occupational, neuropsychological, and psychological variables to establish relationships between the degree of impairment and socio-occupational integration. Quantitative study.

B) Focus groups to determine the contents of the intervention program, which will be co-created as the Aut-CARE program. Qualitative study.

C) Pilot study of the Aut-CARE program to evaluate its format, content, feasibility, and acceptability.

Individuals aged 16 to 30 years with an ASD diagnosis, levels 1 and 2. The calculated sample size is 37 subjects for sub-study A; the minimum sample size for the focus groups (sub-study B) is 14; and a maximum of 10 participants for the pilot study (sub-study C).

Conditions

Autism Spectrum Disorder; Autism Spectrum Disorder With Absence of Functional Language

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Aut-CARE

There is no intervention

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Alejandra Espinosa

Role: CONTACT

AEspinosaG@santpau.cat

+34 93 553 78 13

Muriel Vicent-Gil, Dr

Role: CONTACT

mvicent@santpau.cat

+34 93 553 78 38

Facility Contacts

Maria J Portella, Dr.

Role: primary

mportella@santpau.cat

+34935537836

Júlia Carrasco, Mrs.

Role: backup

jcarrasco@santpau.cat

+34935537837

Other Identifiers

IIBSP-AUT-2024-102

Identifier Type: -

Identifier Source: org_study_id