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NCT Number: NCT07743645

Developing Biomarker-Supported Schizophrenia Spectrum Disorder (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

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Key information

Conditions

Schizophrenia Spectrum Disorders (SSD)

Age range

9 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

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

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

    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. 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.

  3. 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.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Developing Biomarker-Supported SSD Prevention

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Aug 4, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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