- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01167556
Family Motivational Intervention in Schizophrenia (FMI)
Motivational Interviewing and Interaction Skills Training for Carers to Change Cannabis Use in Young Adults With Recent-onset Schizophrenia: Randomised Controlled Trial
Cannabis use by people with schizophrenia is associated with family distress and poor clinical outcomes. Therefore, an Family Motivational Intervention (FMI) was developed to help parents to motivate their child with a diagnoses of recent-onset schizophrenia to reduce cannabis use.
In a single-blind randomised clinical trail with 75 patients with the diagnosis of schizophrenia, parents will be assigned to either FMI or to routine care. Assessments will be conducted at baseline and at a 10- and 22-month follow-up. The study hypothesis is that FMI will be more effective than routine care in reducing (a) cannabis use in patients and (b) distress and sense of burden in parents.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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North Holland
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Amsterdam, North Holland, 네덜란드, 1066 DP
- Academic Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Clinical diagnosis of schizophrenia or psychotic-related disorder
- Onset of schizophrenia or related disorder within pervious the 10 years
- Cannabis use at least 2 days per week in the 3 months prior to the assessment
- Antipsychotic medication in prescribed or indicated
- At least 10 hours of contact with the parents each week in the last month
Exclusion Criteria:
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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Family Motivational Intervention
An intervention provided to parents consisting of 6 sessions of training in Interactions Skills and 6 sessions training in Motivational Interviewing.
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A intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training.
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활성 비교기: Routine care for parents
Routine care for parents consisting of 2 sessions psycho-education and individual support
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A intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Cannabis use in patients with a diagnosis of recent-onset schizophrenia
기간: Baseline (before the start of the intervention)
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Baseline (before the start of the intervention)
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Cannabis use in patients with a diagnosis of recent-onset schizophrenia
기간: 10-month follow-up (3 months after the intervention has ended)
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10-month follow-up (3 months after the intervention has ended)
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Cannabis use in patients with a diagnosis of recent-onset schizophrenia
기간: 22-month follow-up (15 months after the intervention has ended)
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22-month follow-up (15 months after the intervention has ended)
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Medication adherence in patients with a diagnosis of recent-onset schizophrenia
기간: Baseline (before the start of the intervention)
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Baseline (before the start of the intervention)
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Medication adherence in patients with a diagnosis of recent-onset schizophrenia
기간: 10-month follow-up (3 months after the intervention has ended)
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10-month follow-up (3 months after the intervention has ended)
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Medication adherence in patients with a diagnosis of recent-onset schizophrenia
기간: 22-month follow-up (15 months after the intervention has ended)
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22-month follow-up (15 months after the intervention has ended)
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Quality of life in patients with recent-onset schizophrenia
기간: Baseline (before the start of the intervention)
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Baseline (before the start of the intervention)
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Quality of life in patients with recent-onset schizophrenia
기간: 10-month follow-up (3 months after the intervention has ended)
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10-month follow-up (3 months after the intervention has ended)
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Quality of life in patients with recent-onset schizophrenia
기간: 22-month follow-up (15 months after the intervention has ended)
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22-month follow-up (15 months after the intervention has ended)
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Stress in parents due to caring for a child with recent-onset schizophrenia
기간: Baseline (before the start of the intervention)
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Baseline (before the start of the intervention)
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Stress in parents due to caring for a child with recent-onset schizophrenia
기간: 10-month follow-up (3 months after the intervention has ended)
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10-month follow-up (3 months after the intervention has ended)
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Stress in parents due to caring for a child with recent-onset schizophrenia
기간: 22-month follow-up (15 months after the intervention has ended)
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22-month follow-up (15 months after the intervention has ended)
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Expressed emotion in parents of patients with recent-onset schizophrenia
기간: Baseline (before the start of the intervention)
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Baseline (before the start of the intervention)
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Expressed emotion in parents of patients with recent-onset schizophrenia
기간: 10-month follow-up (3 months after the intervention has ended)
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10-month follow-up (3 months after the intervention has ended)
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Expressed emotion in parents of patients with recent-onset schizophrenia
기간: 22-month follow-up (15 months after the intervention has ended)
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22-month follow-up (15 months after the intervention has ended)
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공동 작업자 및 조사자
수사관
- 연구 책임자: Gerard Schippers, Prof. dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- 수석 연구원: Don Linszen, Prof.dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- 연구 의자: Lieuwe de Haan, Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Grant 100003014
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .