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Not yet recruiting NCT07743645

Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention

No phase Interventional Prevention Risk Factors for Mental Illness Family History of Schizophrenia Spectrum Disorder

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: Psychosocial intervention group.
Who it may be relevant to
Registry conditions: Prevention, Risk Factors for Mental Illness, Family History of Schizophrenia Spectrum Disorder. Basic parameters: 9 years — 19 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
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Developing Biomarker-Supported SSD Prevention

Overview

The purpose of this study is to compare the effect of a brief family-based psychosocial intervention that addresses modifiable SSD risk factors on persistent and distressing psychotic-like experiences in children and young adults with a family history of SSD and high versus low baseline SSD-like brain patterns

Interventions

  • Behavioral Psychosocial intervention group
    Over 16 weeks, participants and their parent/legal guardian(s)/caregiver(s) will attend weekly hour long family-based psychosocial intervention to work on their top 2 modifiable SSD-risk factors targeted by the risk reduction therapy (RRT)

Primary outcome measures

  • Change in persistent distressing psychotic-like experiences as assessed by a modified Prodromal Questionnaire Brief-Child Version (PQ-BC) questionnaire [Time frame: Baseline, 8 weeks, end of intervention (16 weeks after baseline ), 1-year follow up]
Secondary outcome measures (3)
  • Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery [Time frame: Baseline, end of intervention (16 weeks after baseline ), 1-year follow up]
  • Change in psychopathology measured by the Child Behavior Checklist (CBCL) [Time frame: Baseline, end of intervention (16 weeks after baseline ), 1-year follow up]
  • Change in stress level measured by the Perceived Stress Scale (PSS) [Time frame: Baseline, end of intervention (16 weeks after baseline ), 1-year follow up]

Eligibility criteria

Inclusion criteria

  • Family history of SSD (defined as first-degree (e.g., a parent or a sibling), second-degree (e.g., an uncle or a grandparent), or other combinations of biological relatives in the family have or likely have a diagnosis of SSD or other closely related severe mental illnesses equivalent to at least 25% of genetic sharing) per medical record review and/or parent/legal guardian report and confirmed by a structured interview
  • screening positive for two or more risk factors targeted by the intervention
  • Participants and parent(s)/legal guardian(s) agree to participate
  • psychiatrically stable and have no major changes in antidepressant, stimulant, or antipsychotic medication in the past 4 weeks.

Exclusion criteria

  • Current or past history of psychotic disorders or clinical high risk for psychosis (CHR-p) per study interview
  • Current or past antipsychotic medication use to specifically treat a psychotic disorder
  • major medical and neurological conditions
  • moderate to severe intellectual disabilities or mild intellectual disabilities but expected to have difficulty completing the study assessments;
  • current drug or alcohol use that impacts functioning and study engagement;
  • Not able to give assent, permission, or consent.
  • Not able to undergo MRI.

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

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT07743645 · HSC-MS-25-0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗