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

NCT07041502 | Recruiting

• 1 other identifier: IIBSP-AUT-2024-102
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Difficulties in emotion regulation scale (DERS)

  The DERS is a measure of emotional dysregulation. The raw scores range from 36 to 180. Higher scores mean more difficulties.

  1 day

• Battery of cognitive tests

  A set of neuropsychological tests is administered: Trail Making Test-A, Trail Making Test-B, Digit Symbol Substitution Test, Digit Span, Letter and Numbers, and Phonetic Fluency (PMR). Scores will be t-transformed (mean=50, SD=10), so high scores mean better performance.

  1 day

Interventions

Aut-CARE OTHER

There is no intervention

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals (females and males) aged 16 to 30 years with an ASD diagnosis, levels 1 and 2

You may qualify if:

• 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).

You may not qualify if:

• None

Sponsors & Collaborators

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

Study Sites (1)

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

Barcelona, Catalonia, 08041, Spain

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Alejandra Espinosa

CONTACT

+34 93 553 78 13; AEspinosaG@santpau.cat

Muriel Vicent-Gil, Dr

CONTACT

+34 93 553 78 38; mvicent@santpau.cat

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 27, 2025
• Study Start: October 16, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

ES (1)