Schizophrenia Spectrum Disorders (SSD)NCT07743645
Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention
A study testing Psychosocial intervention group in people with Schizophrenia Spectrum Disorders (SSD), run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 9 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia Spectrum Disorders (SSD)
- What is being tested?
- Psychosocial intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Yizhou Ma, PhD, 713-486-2740, Yizhou.Ma@uth.tmc.edu
Oluwabunmi Akindona, BA, 713-486-2740, L.Elliot.Hong@uth.tmc.edu
About this study
Official title: 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
- Conditions
- Schizophrenia Spectrum Disorders (SSD)
- Being tested
- Psychosocial intervention group
- Keywords
- Risk Reduction Therapy (RRT), Prevention, family history of schizophrenia spectrum disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial intervention groupBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Psychosocial intervention group | Experimental | Not described Receives: Behavioral: Psychosocial intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8 weeks, end of intervention (16 weeks after baseline ), 1-year follow up
Secondary outcomes (3)
Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery
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.
Measured: Baseline, end of intervention (16 weeks after baseline ), 1-year follow up
Change in psychopathology measured by the Child Behavior Checklist (CBCL)
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.
Measured: Baseline, end of intervention (16 weeks after baseline ), 1-year follow up
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.
Measured: Baseline, end of intervention (16 weeks after baseline ), 1-year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Sep 2026
- Primary completion1 Apr 2031 (estimated)
- Study completion1 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia Spectrum Disorders (SSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Yizhou Ma, The University of Texas Health Science Center, Houston
- Investigators
- Yizhou Ma, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743645
- Sponsor's protocol ID
- HSC-MS-25-0001
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Biomarker-Supported SSD Prevention
- ClinicalTrials.gov ID
- NCT07743645
- Acronym / sponsor ID
- HSC-MS-25-0001
- Conditions
- Schizophrenia Spectrum Disorders (SSD)
- Keywords
- Risk Reduction Therapy (RRT), Prevention, family history of schizophrenia spectrum disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Apr 2031 (estimated)
- Study completion
- 1 Apr 2031 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychosocial intervention group | Experimental | Behavioral: Psychosocial intervention group |
Who may qualify
- Ages
- 9 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial intervention groupOver 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) | Behavioural | Psychosocial intervention group |
Primary outcome
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.
3 secondary outcomes
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 psychopathology measured by the Child Behavior Checklist (CBCL)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yizhou Ma, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial intervention group in people with Schizophrenia Spectrum Disorders (SSD), run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yizhou Ma, PhD (713-486-2740, Yizhou.Ma@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.