Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07427810

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

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.

Treatment and study plan

None. Observational study.

Other

None. Observational study.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sverre Wikström, Assoc Prof

CONTACT

[email protected]

+46703456327

Sponsors and collaborators

Lead sponsor

Värmland County Council, Sweden

Other Gov

Registry information

Official study title

Follow-up of Current Psychotic Symptoms, Level of Function and Psychiatric Co-morbidity Among Adolescents With Autism, 10 Years After Identification of Psychotic Symptoms.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

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.

Published trials that share one or more normalized conditions with this study.