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
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Yizhou Ma, PhD
- 전화번호: 713-486-2740
- 이메일: Yizhou.Ma@uth.tmc.edu
연구 연락처 백업
- 이름: Oluwabunmi Akindona, BA
- 전화번호: 713-486-2740
- 이메일: Oluwabunmi.Akindona@uth.tmc.edu
연구 장소
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Texas
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Houston, Texas, 미국, 77030
- 모병
- The University of Texas Health Science Center at Houston
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연락하다:
- Yizhou Ma, PhD
- 전화번호: 713-486-2740
- 이메일: Yizhou.Ma@uth.tmc.edu
-
연락하다:
- Oluwabunmi Akindona, BA
- 전화번호: 713-486-2740
- 이메일: L.Elliot.Hong@uth.tmc.edu
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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) |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in persistent distressing psychotic-like experiences as assessed by a modified Prodromal Questionnaire Brief-Child Version (PQ-BC) questionnaire
기간: Baseline, 8 weeks, end of intervention (16 weeks after baseline ), 1-year follow up
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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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery
기간: Baseline, end of intervention (16 weeks after baseline ), 1-year follow up
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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)
기간: 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)
기간: 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
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공동 작업자 및 조사자
스폰서
스폰서
협력자
협력자
수사관
수사관
- 수석 연구원: Yizhou Ma, PhD, The University of Texas Health Science Center, Houston
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- HSC-MS-25-0001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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