Recruiting

Psychosocial Intervention

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT07743645

Conditions

Schizophrenia Spectrum Disorders (SSD)

Eligibility Criteria

Sex: All

Age: 9 - 19

Healthy Volunteers: Accepted

Interventions

Psychosocial intervention group

Study Details

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

Conditions

Schizophrenia Spectrum Disorders (SSD)

Study ID

NCT07743645

Start date

Sep 1, 2026

Status verified date

Jul, 2026

Completion date

Apr 1, 2031

Anticipated

Primary completion date

Apr 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 19

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Psychosocial intervention group

Interventions

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)

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Yizhou Ma, PhD

713-486-2740Yizhou.Ma@uth.tmc.edu

Oluwabunmi Akindona, BA

713-486-2740Oluwabunmi.Akindona@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Yizhou Ma, PhD

713-486-2740Yizhou.Ma@uth.tmc.edu

Oluwabunmi Akindona, BA

713-486-2740L.Elliot.Hong@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Sep 23, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.