Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention

NCT07743645 | Recruiting DMC

• 1 other identifier: HSC-MS-25-0001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia Spectrum Disorders (SSD)

Keywords

Risk Reduction Therapy (RRT); Prevention; family history of schizophrenia spectrum disorder

Outcome Measures

Primary Outcomes (1)

• Change in persistent distressing psychotic-like experiences as assessed by a modified Prodromal Questionnaire Brief-Child Version (PQ-BC) questionnaire

  This is a 21 item questionnaire and items are scored as 0 (symptom not endorsed) or 1 (symptom endorsed). Items endorsed are further assessed for level of distress (1-5) and chronicity (present 6 months, 1 year, 2 years, or more than 2 years ago). The total symptom score is calculated as the sum of distress ratings of all items at baseline with 1) "Did it bother you?" answered "Y" AND 2) endorsed as distressing at one or more previous time points. The range of the total symptom score is 0 to 105. Higher scores indicate greater distressing and persistent psychotic-like experiences.

  Baseline, 8 weeks, end of intervention (16 weeks after baseline ), 1-year follow up

Secondary Outcomes (3)

• Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery

  Baseline, end of intervention (16 weeks after baseline ), 1-year follow up

• Change in psychopathology measured by the Child Behavior Checklist (CBCL)

  Baseline, end of intervention (16 weeks after baseline ), 1-year follow up

• Change in stress level measured by the Perceived Stress Scale (PSS)

  Baseline, end of intervention (16 weeks after baseline ), 1-year follow up

Study Arms (1)

Psychosocial intervention group

EXPERIMENTAL

Behavioral: Psychosocial intervention group

Interventions

Psychosocial intervention group BEHAVIORAL

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)

Psychosocial intervention group

Eligibility Criteria

• Age: 9 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Study Officials

• Yizhou Ma, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yizhou Ma, PhD

CONTACT

713-486-2740; Yizhou.Ma@uth.tmc.edu

Oluwabunmi Akindona, BA

CONTACT

713-486-2740; Oluwabunmi.Akindona@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031
• Last Updated: September 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)