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RecruitingNCT07743645Updated Oct 30, 2026

Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention

An interventional study of Psychosocial intervention group in Schizophrenia Spectrum Disorders (SSD), sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to participants aged 9 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Updated Oct 30, 2026Eligibility revisedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
9 Years to 26 Years
Sex
All
01

Study 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

02

Conditions studied

  • Schizophrenia Spectrum Disorders (SSD)

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Keywords

  • Risk Reduction Therapy (RRT)
  • Prevention
  • family history of schizophrenia spectrum disorder
03

In context

Schizophrenia

3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.

This study's planned enrollment of 100 is above the median of 71 across 2,944 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 30, 2026. See what changed

Ages eligible
9 Years to 26 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Psychosocial intervention group

    Behavioral: Psychosocial intervention group

Interventions

  • BehavioralPsychosocial 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)

06

What researchers measure

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.

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

Secondary outcomes

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

    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.

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

  2. Change in psychopathology measured by the Child or Adult Behavior Checklist (CBCL or ABCL)

    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.

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

  3. 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.

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Apr 2031, 55 months after the start.

Of 753 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 55 months is above that.

Counting every sponsor, half of 766 studies reached it within 32 months; a quarter within 16 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2026
First posted
Aug 4, 2026
StartActual
Sep 1, 2026
Primary completionEst.
Apr 1, 2031
CompletionEst.
Apr 1, 2031
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
Maximum age 19 Years→26 Years; 2 inclusion criteria edited, 1 added
What changed in the criteria
Inclusion criteria
  • EditedFamily 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;
  • Addedaged ≥ 9 and <26 years of birthday;
  • EditedParticipants and parent(s)/legal guardian(s)/other family member(s) agree to participate;
Oct 30, 2026
Secondary outcomes
1 edited, 1 description edited
What changed in the outcomes
  • EditedChange 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
  • DescriptionChange in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery: how it is measured was reworded
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    Eligibility Maximum age 19 Years→26 Years; 2 inclusion criteria edited, 1 added
    What changed in the criteria
    Inclusion criteria
    • EditedFamily 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;
    • Addedaged ≥ 9 and <26 years of birthday;
    • EditedParticipants and parent(s)/legal guardian(s)/other family member(s) agree to participate;
    Secondary outcomes 1 edited, 1 description edited
    What changed in the outcomes
    • EditedChange 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
    • DescriptionChange in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery: how it is measured was reworded
    + 2 other changes: verification date and arm descriptions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07743645
Responsible party
Yizhou Ma (Instructor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Aug 4, 2026
Start date
Sep 1, 2026
Primary completion
Apr 1, 2031 (estimated)
Completion
Apr 1, 2031 (estimated)
Last update
Oct 30, 2026

Study contacts

Yizhou Ma, PhD
Contact
Yizhou.Ma@uth.tmc.edu
713-486-2740
Oluwabunmi Akindona, BA
Contact
Oluwabunmi.Akindona@uth.tmc.edu
713-486-2740
Yizhou Ma, PhD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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