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- Klinische proef NCT07743645
Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention
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
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Yizhou Ma, PhD
- Telefoonnummer: 713-486-2740
- E-mail: Yizhou.Ma@uth.tmc.edu
Studie Contact Back-up
- Naam: Oluwabunmi Akindona, BA
- Telefoonnummer: 713-486-2740
- E-mail: Oluwabunmi.Akindona@uth.tmc.edu
Studie Locaties
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Texas
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Houston, Texas, Verenigde Staten, 77030
- Werving
- The University of Texas Health Science Center at Houston
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Contact:
- Yizhou Ma, PhD
- Telefoonnummer: 713-486-2740
- E-mail: Yizhou.Ma@uth.tmc.edu
-
Contact:
- Oluwabunmi Akindona, BA
- Telefoonnummer: 713-486-2740
- E-mail: L.Elliot.Hong@uth.tmc.edu
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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/self report and confirmed by a structured interview;
- screening positive for two or more risk factors targeted by the intervention;
- aged ≥ 9 and <26 years of birthday;
- Participants and parent(s)/legal guardian(s)/other family member(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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Psychosocial intervention group
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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) |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in persistent distressing psychotic-like experiences as assessed by a modified Prodromal Questionnaire Brief-Child Version (PQ-BC) questionnaire
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery
Tijdsspanne: 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
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|
Change in psychopathology measured by the Child or Adult Behavior Checklist (CBCL or ABCL)
Tijdsspanne: Baseline, end of intervention (16 weeks after baseline ), 1-year follow up
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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
|
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Change in stress level measured by the Perceived Stress Scale (PSS)
Tijdsspanne: Baseline, end of intervention (16 weeks after baseline ), 1-year follow up
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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
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Yizhou Ma, PhD, The University of Texas Health Science Center, Houston
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- HSC-MS-25-0001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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