Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention

Официальное название

Developing Biomarker-Supported SSD Prevention

Обзор

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

Вмешательства

• Поведенческое 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)

Первичные конечные точки

• Change in persistent distressing psychotic-like experiences as assessed by a modified Prodromal Questionnaire Brief-Child Version (PQ-BC) questionnaire [Срок оценки: Baseline, 8 weeks, end of intervention (16 weeks after baseline ), 1-year follow up]

Вторичные конечные точки (3)

• Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery [Срок оценки: Baseline, end of intervention (16 weeks after baseline ), 1-year follow up]
• Change in psychopathology measured by the Child Behavior Checklist (CBCL) [Срок оценки: Baseline, end of intervention (16 weeks after baseline ), 1-year follow up]
• Change in stress level measured by the Perceived Stress Scale (PSS) [Срок оценки: Baseline, end of intervention (16 weeks after baseline ), 1-year follow up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT07743645 · HSC-MS-25-0001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗