Karlstad central Hospital
Karlstad, Värmland County, 65230, Sweden
Location status: Recruiting
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 this study, 22 participant reported psychotic symptom in self-evaluation questionnaires design for early detection.
An additional 5 individuals were recruited in a second round of recruitment in 2019. Three of these individuals reported psychotic symptoms.
We aim to recruit individuals with psychotic symptoms 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.
Interested in participating?
Request Info20 year–35 year
All sexes
Observational
Karlstad, Värmland County, 65230, Sweden
Location status: Recruiting
Design:
Cohort 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.
An additional 5 individuals were recruited in a second round of recruitment in 2019. Three of these individuals reported psychotic symptoms.
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.
Brief psychiatric rating scale: Structured clinical interview assessing positive and negative psychotic symptoms.
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 BPRS, 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
Exclusion criteria
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
Longitudinal Follow-up of Psychiatric Symptoms and Functioning in Young Adults With Autism.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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