Autism DisorderNCT07427810
Follow-up of Adolescents With Autism and Psychotic Symptoms - Psychiatric Co-morbidity and Functional Impairment.
An observational study of Autism Disorder and Schizophrenia and Other Psychotic Disorders, run by Värmland County Council, Sweden at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Autism Disorder, Schizophrenia and Other Psychotic Disorders
- What is being tested?
- None. Observational study.
- How many people
- 53 participants
- Where
- 1 siteSweden
- Study dates
- 13 Jul 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Age 15-18 at enrollment for the original study,
- Autism spectrum disorder.
- IQ>70.
Who cannot join
- Non.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karlstad central Hospital
Karlstad, Värmland County, 65230
About this study
Official title: Longitudinal Follow-up of Psychiatric Symptoms and Functioning in Young Adults With Autism.
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.
Read more
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.
- Being tested
- None. Observational study.
- Medical subject headings
- Autistic Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None. Observational study.Other
None. Observational study.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Autism and psychotic symptoms Receives: Other: None. Observational study. | |
| Controls | Autism without psychotic symptoms Receives: Other: None. Observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with psychotic disease
Measured: Single time point at enrollment
Secondary outcomes (3)
Number of participants with non-psychotic psychiatric disease
Measured: Single time point at enrollment
Number of participants with psychotic symptoms without psychotic disease
Measured: Single time point at enrollment
Number of participants with functional impairment
Measured: Single time point at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start13 Jul 2026
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Värmland County Council, Sweden
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sverre Wikström, Principal investigator, Region Värmland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427810
- Sponsor's protocol ID
- 283356
- Status last verified
- Aug 2026
- First submitted
- 17 Feb 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Follow-up of Psychiatric Symptoms and Functioning in Young Adults With Autism.
- ClinicalTrials.gov ID
- NCT07427810
- Acronym / sponsor ID
- 283356
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Värmland County Council, SwedenOther government
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: None. Observational study.Autism and psychotic symptoms |
| Controls | – | Other: None. Observational study.Autism without psychotic symptoms |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Age 15-18 at enrollment for the original study,
- Autism spectrum disorder.
- IQ>70.
Key exclusion criteria (1 listed)
- Non.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None. Observational study.None. Observational study. | Other | Cases, Controls |
Primary outcome
Number of participants with psychotic disease
Time frame: Single time point at enrollment
3 secondary outcomes
Number of participants with non-psychotic psychiatric disease
Time frame: Single time point at enrollment
Number of participants with psychotic symptoms without psychotic disease
Time frame: Single time point at enrollment
Number of participants with functional impairment
Time frame: Single time point at enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sverre Wikström principal investigator
Region Värmland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Disorder and Schizophrenia and Other Psychotic Disorders, run by Värmland County Council, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sverre Wikström, Assoc Prof (+46703456327, sverre.wikstrom@regionvarmland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with psychotic disease (time frame: Single time point at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.