NCT07427810

Brief 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 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
18mo left

Started Feb 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Feb 2026Dec 2027

Study Start

First participant enrolled

February 1, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

February 17, 2026

Last Update Submit

February 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants with psychotic disease

    Single time point at enrollment

Secondary Outcomes (3)

  • Number of participants with non-psychotic psychiatric disease

    Single time point at enrollment

  • Number of participants with psychotic symptoms without psychotic disease

    Single time point at enrollment

  • Number of participants with functional impairment

    Single time point at enrollment

Study Arms (2)

Cases

Autism and psychotic symptoms

Other: None. Observational study.

Controls

Autism without psychotic symptoms

Other: None. Observational study.

Interventions

None. Observational study.

CasesControls

Eligibility Criteria

Age25 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Autistic DisorderSchizophrenia

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Sverre Wikström

    Region Värmland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sverre Wikström, Assoc Prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2026

First Posted

February 23, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share