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Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention

27 oktober 2026 uppdaterad av: Yizhou Ma, The University of Texas Health Science Center, Houston

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

Studieöversikt

Status

Rekrytering

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

9 år till 26 år (Barn, Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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:

  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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Psychosocial 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)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in persistent distressing psychotic-like experiences as assessed by a modified Prodromal Questionnaire Brief-Child Version (PQ-BC) questionnaire
Tidsram: 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.

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery
Tidsram: Baseline, end of intervention (16 weeks after baseline ), 1-year follow up

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.

Baseline, end of intervention (16 weeks after baseline ), 1-year follow up
Change in psychopathology measured by the Child or Adult Behavior Checklist (CBCL or ABCL)
Tidsram: Baseline, end of intervention (16 weeks after baseline ), 1-year follow up

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.

Baseline, end of intervention (16 weeks after baseline ), 1-year follow up
Change in stress level measured by the Perceived Stress Scale (PSS)
Tidsram: 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.

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Yizhou Ma, PhD, The University of Texas Health Science Center, Houston

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 september 2026

Primärt slutförande (Beräknad)

1 april 2031

Avslutad studie (Beräknad)

1 april 2031

Studieregistreringsdatum

Först inskickad

30 juli 2026

Först inskickad som uppfyllde QC-kriterierna

30 juli 2026

Första postat (Faktisk)

4 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

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Nej

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Nej

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