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RecruitingNCT07427810Updated Sep 2, 2026

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

An observational study in Autism Disorder and Schizophrenia and Other Psychotic Disorders, sponsored by Värmland County Council, Sweden. Recruiting at 1 site in Sweden. Open to participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Värmland County Council, Sweden · Observational

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
53
Ages
20 Years to 35 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Autism Disorder
  • Schizophrenia and Other Psychotic Disorders
03

In context

Autistic Disorder

1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.

This study's planned enrollment of 53 is below the median of 101 across 189 observational studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Värmland County Council, Sweden is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
All
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.

An additional 5 individuals were recruited in a second round of recruitment in 2019. Three of these individuals reported psychotic symptoms.

Individuals with psychotic symptoms will be re-recruited along with controls from the same cohort without psychotic symptoms.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 15-18 at enrollment for the original study,
  • Autism spectrum disorder.
  • IQ>70.

Exclusion criteria

Exclusion Criteria:

- Non.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
53 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cases

    Autism and psychotic symptoms

    Other: None. Observational study.

  • Controls

    Autism without psychotic symptoms

    Other: None. Observational study.

Interventions

  • OtherNone. Observational study.

    None. Observational study.

06

What researchers measure

Primary outcomes

  1. Number of participants with psychotic disease

    Time frame: Single time point at enrollment

Secondary outcomes

  1. Number of participants with non-psychotic psychiatric disease

    Time frame: Single time point at enrollment

  2. Number of participants with psychotic symptoms without psychotic disease

    Time frame: Single time point at enrollment

  3. Number of participants with functional impairment

    Time frame: Single time point at enrollment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07427810
Lead sponsor
Värmland County Council, Sweden
Responsible party
Sponsor
First posted
Feb 23, 2026
Start date
Jul 13, 2026
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 2, 2026

Study contacts

Sverre Wikström, Assoc Prof
Contact
sverre.wikstrom@regionvarmland.se
+46703456327
Sverre Wikström
principal investigator · Region Värmland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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