- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07427810
Follow-up of Adolescents With Autism and Psychotic Symptoms - Psychiatric Co-morbidity and Functional Impairment.
Follow-up of Current Psychotic Symptoms, Level of Function and Psychiatric Co-morbidity Among Adolescents With Autism, 10 Years After Identification of Psychotic Symptoms.
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sverre Wikström, Assoc Prof
- Phone Number: +46703456327
- Email: sverre.wikstrom@regionvarmland.se
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: Age 15-18 at enrollment for the original study, autism spectrum disease, IQ>70.
Exclusion Criteria: Non.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cases
Autism and psychotic symptoms
|
None. Observational study.
|
|
Controls
Autism without psychotic symptoms
|
None. Observational study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants with psychotic disease
Time Frame: Single time point at enrollment
|
Single time point at enrollment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants with non-psychotic psychiatric disease
Time Frame: Single time point at enrollment
|
Single time point at enrollment
|
|
Number of participants with psychotic symptoms without psychotic disease
Time Frame: Single time point at enrollment
|
Single time point at enrollment
|
|
Number of participants with functional impairment
Time Frame: Single time point at enrollment
|
Single time point at enrollment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sverre Wikström, Region Värmland
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 283356
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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