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

February 17, 2026 updated by: Värmland County Council, Sweden

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

Not yet recruiting

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

Observational

Enrollment (Estimated)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants are recruited from a prevoiusly established cohort (Region Värmland 2013) including 48 adolescents with autism. 22 participants reported psychotic symptom using self-assessment questionnaires. These individuals will be re-recruited along with controls from the same cohort without psychotic symptoms.

Description

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

Exclusion Criteria: Non.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sverre Wikström, Region Värmland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Autism Disorder

Clinical Trials on None. Observational study.

Subscribe