None. Observational study.
OtherNone. Observational study.
NCT Number: NCT07427810
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.
Trial opening soon.
Get Notified25 year–35 year
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Age 15-18 at enrollment for the original study, autism spectrum disease, IQ>70.
Exclusion criteria
Non.
None. Observational study.
Time frame: Single time point at enrollment
Time frame: Single time point at enrollment
Time frame: Single time point at enrollment
Time frame: Single time point at enrollment
Contact information is provided by the study sponsor or research team.
Värmland County Council, Sweden
Other Gov
Follow-up of Current Psychotic Symptoms, Level of Function and Psychiatric Co-morbidity Among Adolescents With Autism, 10 Years After Identification of Psychotic Symptoms.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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