Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT07041502
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).
Study:
NCT07041502
Study Brief:
Protocol Section:
NCT07041502