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Идёт набор NCT07041502

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

— Наблюдательное Autism Spectrum Disorder Autism Spectrum Disorder With Absence of Functional Language

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Aut-CARE.
Кому может быть актуально
Состояния в реестре: Autism Spectrum Disorder, Autism Spectrum Disorder With Absence of Functional Language. Базовые параметры: 16 лет — 30 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

  • Другое Aut-CARE
    There is no intervention

Первичные конечные точки

  • Difficulties in emotion regulation scale (DERS) [Срок оценки: 1 day]
  • Battery of cognitive tests [Срок оценки: 1 day]

Критерии участия

Критерии включения

  • 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).

Критерии исключения

  • None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Испания · 1 центр
  • Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau — Barcelona

Идентификаторы

NCT: NCT07041502 · IIBSP-AUT-2024-102

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗