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Набор скоро начнётся NCT07427810

Follow-up of Adolescents With Autism and Psychotic Symptoms - Psychiatric Co-morbidity and Functional Impairment.

Наблюдательное Autism Disorder Schizophrenia and Other Psychotic Disorders

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: None. Observational study..
Кому может быть актуально
Состояния в реестре: Autism Disorder, Schizophrenia and Other Psychotic Disorders. Базовые параметры: 25 лет — 35 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Follow-up of Current Psychotic Symptoms, Level of Function and Psychiatric Co-morbidity Among Adolescents With Autism, 10 Years After Identification of Psychotic Symptoms.

Обзор

Purpose: To describe level of function, psychotic and psychiatric symptoms in a 10-year follow up of individuals with autism and psychotic symptoms. Method: A case-control study based on a cohort of 48 teenagers with autism established 2013. In the original study, 22 participant reported psychotic symptom in self-evaluation questionnaires design for early detection. We aim to recruit these individuals and controls from the same cohort without psychotic symptoms. Data will be collected from self-rating scales, clinical evaluation including semi-structured interviews and healthcare journals. The study is primarily descriptive, with group comparison by non-parametric method.

Подробное описание

Design:

Case-control study.

Participants:

Participants will be recruited from a previous study cohort established in Region Varmland in 2013, comprising 48 adolescents diagnosed with autism. Psychotic symptoms were identified through self-report in 22 participants. These individuals will be re recruited, along with controls from the same cohort with autism but no psychotic symptoms.

In the original study, participants were 15-18 years old at the time of screening, had a diagnosis of autism spectrum disorder (including Asperger's syndrome), and an IQ ≥ 70.

Instruments:

Youth Psychosis at Risk Questionnaire - Brief Version (YPARQ B). A shortened version of the Youth Psychosis at Risk Questionnaire developed to capture early psychotic symptoms.

Prodromal Questionnaire - Brief Version (PQ B): Self report scale assessing psychotic symptoms, including associated distress.

Montgomery-Åsberg Depression Rating Scale - Self Report (MADRS S): Swedish self report scale for depressive symptoms.

Self evaluation of Negative Symptoms (SNS): Instrument for assessing negative symptoms in psychotic disorders; Swedish translation available.

Positive and Negative Syndrome Scale (PANSS): Structured clinical interview assessing positive and negative psychotic symptoms; validated and translated into Swedish.

Structured Clinical Interview for DSM 5, Clinician Version (SCID 5 CV): Semi structured diagnostic interview.

Mini International Neuropsychiatric Interview (MINI): Structured diagnostic interview.

Clinical Global Impression - Severity (CGI S): Clinician rated scale for assessing severity of psychiatric illness.

Personal and Social Performance Scale (PSP): Clinician rated measure of global functioning in psychotic disorders.

Procedure:

Approximately ten years after the initial study recruitment, participants will complete PQ B, YPARQ B, SNS, and MADRS-S. Current psychotic symptoms and psychiatric comorbidity will be assessed in clinical evaluation, including PANSS, the psychosis module of SCID 5 CV, and MINI.

Socioeconomic status will be assessed. Functional level will be rated using CGI-S and PSP.

With participant consent, information regarding psychiatric diagnoses and current pharmacological treatment will be requested from healthcare region.

Analysis:

Group comparisons will be conducted using non parametric methods. A roughly 1:1 ratio between case and control groups is expected.

Вмешательства

  • Другое None. Observational study.
    None. Observational study.

Первичные конечные точки

  • Number of participants with psychotic disease [Срок оценки: Single time point at enrollment]
Вторичные конечные точки (3)
  • Number of participants with non-psychotic psychiatric disease [Срок оценки: Single time point at enrollment]
  • Number of participants with psychotic symptoms without psychotic disease [Срок оценки: Single time point at enrollment]
  • Number of participants with functional impairment [Срок оценки: Single time point at enrollment]

Критерии участия

Inclusion Criteria: Age 15-18 at enrollment for the original study, autism spectrum disease, IQ>70.

Exclusion Criteria: Non.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07427810 · 283356

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗