Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention

October 27, 2026 updated by: Yizhou Ma, The University of Texas Health Science Center, Houston

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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/self report and confirmed by a structured interview;
  2. screening positive for two or more risk factors targeted by the intervention;
  3. aged ≥ 9 and <26 years of birthday;
  4. Participants and parent(s)/legal guardian(s)/other family member(s) agree to participate;
  5. psychiatrically stable and have no major changes in antidepressant, stimulant, or antipsychotic medication in the past 4 weeks.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Psychosocial intervention group
Behavioral: Psychosocial intervention group

Over 16 weeks, participants and their parent(s)/legal guardian(s)/other family member(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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Baseline, 8 weeks, end of intervention (16 weeks after baseline ), 1-year follow up

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 Cognitive Function as assessed by the NIH Toolbox Cognitive Test Battery (List Sorting Working Memory and Pattern Comparison Processing Speed subtests) and the Rey Auditory Verbal Learning test (RAVLT). Measured at baseline, end-of-intervention (16 weeks after baseline), and 1-year follow-up. Higher scores indicate better cognitive performance. For NIH Tooolbox, 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. For the RAVLT, raw scores will be used.
Baseline, end of intervention (16 weeks after baseline ), 1-year follow up
Change in psychopathology measured by the Child or Adult Behavior Checklist (CBCL or ABCL)
Time Frame: Baseline, end of intervention (16 weeks after baseline ), 1-year follow up

CBCL and ABCL are questionnaires containing ~120 items 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. Scores between 50 and 64 are within the normal range. Scores between 65 and 69 are within the borderline range. Scores above 70 are within the clinical range.
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

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yizhou Ma, PhD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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