Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention

Developing Biomarker-Supported SSD Prevention

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

Study Overview

• Status: Not yet recruiting
• Conditions: Prevention; Risk Factors for Mental Illness; Family History of Schizophrenia Spectrum Disorder
• Intervention / Treatment: Behavioral: Psychosocial intervention group

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yizhou Ma, PhD; Phone Number: 713-486-2700; Email: Yizhou.Ma@uth.tmc.edu
• Study Contact Backup: Name: L. Elliot Hong, MD; Phone Number: 713-486-2500; Email: L.Elliot.Hong@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Yizhou Ma, PhD; Phone Number: 713-486-2700; Email: Yizhou.Ma@uth.tmc.edu
      • Contact: L. Elliot Hong, MD; Phone Number: 713-486-2500; Email: L.Elliot.Hong@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psychosocial intervention group	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery	The NIH Toolbox subtests including List Sorting Working Memory, Pattern Comparison Processing Speed, and Rey Auditory Verbal Learning will be used. Higher scores indicate better cognitive performance. Raw scores of the test taker are compared to the scores in the NIH Toolbox nationally representative normative sample to derive standard scores. The mean standard score is 100 and the standard deviation (SD) is 15. A score at or near 100 indicates average ability compared with others. Scores around 115 suggest above-average ability. Scores around 130 suggest superior ability (in the top 2 percent nationally). A score around 85 suggests below-average ability. A score in the range of 70 or below suggests significant impairment.	Baseline, end of intervention (16 weeks after baseline ), 1-year follow up
Change in psychopathology measured by the Child Behavior Checklist (CBCL)	This is a 113 item questionnaire and each problem item is scored as: 0 (not true) 1(somewhat or sometimes true) and 2 (very true or often true). Raw scores are summed and converted to age- and sex-normed T-scores. Higher T-scores indicate greater overall psychopathology	Baseline, end of intervention (16 weeks after baseline ), 1-year follow up
Change in stress level measured by the Perceived Stress Scale (PSS)	This is a 10 item questionnaire and each item is scored on a 5-point scale from 0(never) to 4 (very often). Positively worded items are reverse scored, and all items are summed to generate a total score ranging from 0 to 40. Higher scores indicate greater perceived stress.	Baseline, end of intervention (16 weeks after baseline ), 1-year follow up

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Yizhou Ma, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031

Study Registration Dates

• First Submitted: July 30, 2026
• First Submitted That Met QC Criteria: July 30, 2026
• First Posted (Actual): August 4, 2026

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: July 30, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Prevention; Risk Reduction Therapy (RRT); family history of schizophrenia spectrum disorder
• Other Study ID Numbers: HSC-MS-25-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No