Skip to content

Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention

Developing Biomarker-Supported SSD Prevention

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07743645
Enrollment
100
Registered
2026-08-04
Start date
2026-10-01
Completion date
2031-04-01
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Family History of Schizophrenia Spectrum Disorder, Prevention, Risk Factors for Mental Illness

Keywords

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

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

Interventions

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)

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to 19 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in persistent distressing psychotic-like experiences as assessed by a modified Prodromal Questionnaire Brief-Child Version (PQ-BC) questionnaireBaseline, 8 weeks, end of intervention (16 weeks after baseline ), 1-year follow upThis 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.

Secondary

MeasureTime frameDescription
Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test BatteryBaseline, end of intervention (16 weeks after baseline ), 1-year follow upThe 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.
Change in psychopathology measured by the Child Behavior Checklist (CBCL)Baseline, end of intervention (16 weeks after baseline ), 1-year follow upThis 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
Change in stress level measured by the Perceived Stress Scale (PSS)Baseline, end of intervention (16 weeks after baseline ), 1-year follow upThis 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.

Countries

United States

Contacts

CONTACTYizhou Ma, PhD
Yizhou.Ma@uth.tmc.edu713-486-2700
CONTACTL. Elliot Hong, MD
L.Elliot.Hong@uth.tmc.edu713-486-2500
PRINCIPAL_INVESTIGATORYizhou Ma, PhD

The University of Texas Health Science Center, Houston

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026