- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04806542
Two-year Follow-up of a Mindfulness-based Intervention in Children.
A Mindfulness-based Intervention Improves Resilience, Anxiety, Anger and Disruptive Behaviour in Children With Mental Health Problems: A 2-year Follow-up Study
The primary aim of this study was to determine whether an 8-week mindfulness-based intervention, called Training for Mindfulness and Resilience (TMR), mitigates moderate mental health symptoms and increases resilience during a 2-year follow-up.
Methods
The participants were 34 schoolchildren in age range of 9-14 years, reporting moderate mental health problems. Participants were randomised into either TMR intervention group (N=22) or control group, receiving best current practice (N=12). The investigators used validated self-rating questionnaires to measure anxiety, depression, anger, disruptive behaviour, self-concept, resilience, stress and mindfulness before treatment with either TMR or control, as well as at 6 months, 1 year and 2 years after treatment period.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- F32.0 Mild depressive episode
- F32.1 Moderate depressive episode
- F41 Anxiety disorders
- F43 Reactions to stress
- F51 Nonorganic sleep disorders
- F93 Emotional disorders with onset specific to childhood
- F94.8 Other childhood disorders of social functioning
- F94.9 Other childhood disorder of social functioning, unspecified
Exclusion Criteria:
- Ongoing treatment for severe psychiatric disorders (F20-29, F31-F33.3)
- Cognitive disorders
- Difficulties in understanding Swedish
- Neuropsychiatric considerations and diagnosis
- Learning disabilities with difficulties in verbal understanding
- Ongoing parental conflict in conjunction with separation/divorce.
- Attending less than 5 of the 8 sessions of the TMR program.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: TMR-group
8-week program for schoolchildren called TMR (Training for Resilience and Mindfulness).
|
A mindfulness-based 8 week program.
|
활성 비교기: Treatment as Usual
Individual counselling.
|
Individual counselling.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Anxiety, depression, anger, disruptive behaviour, self-concept according to Beck Youth Inventories.
기간: Change from Baseline anxiety, depression, anger, disruptive behaviour and self-concept at 2 years.
|
The investigators used validated self-rating questionnaires called Beck Youth Inventories.
Maximum score 300, minimum score 0. Higher values indicate worse outcome except on subscale measuring self-concept where higher score indicate better outcome .
|
Change from Baseline anxiety, depression, anger, disruptive behaviour and self-concept at 2 years.
|
Resilience.
기간: Change from Baseline Resilience at 2 years.
|
The investigators used a validated self-rating questionnaire called Resilience Scale 10.
Maximum score 40, minimum score 10.
Higher values indicate better outcome.
|
Change from Baseline Resilience at 2 years.
|
Stress.
기간: Change from Baseline stress at 2 years.
|
The investigators used a validated self-rating questionnaire called Stress in Children.
Maximum score 92, minimum score 23.
Higher values indicate better outcome.
|
Change from Baseline stress at 2 years.
|
Mindfulness.
기간: Change from Baseline mindfulness at 2 years.
|
The investigators used a validated self-rating questionnaire called Child and Adolescent Mindfulness Measure (CAMM).
Maximum score 40, minimum score 0. Higher values indicate better outcome.
|
Change from Baseline mindfulness at 2 years.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- TMR-study
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
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. .
정신 건강 문제에 대한 임상 시험
-
University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH) 그리고 다른 협력자들모집하지 않고 적극적으로
-
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-
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-
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