Menu
Not yet recruiting NCT07427810

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

Observational Autism Disorder Schizophrenia and Other Psychotic Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: None. Observational study..
Who it may be relevant to
Registry conditions: Autism Disorder, Schizophrenia and Other Psychotic Disorders. Basic parameters: 25 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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.

Overview

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.

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.

Interventions

  • Other None. Observational study.
    None. Observational study.

Primary outcome measures

  • Number of participants with psychotic disease [Time frame: Single time point at enrollment]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

Exclusion Criteria: Non.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07427810 · 283356

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗