- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03144739
Collaborative Care for Children's Mental Health Problems
Collaborative Child Mental Healthcare in Low-Resource Settings
Background: Mental health problems cause a disproportionate burden of disability among children and youth compared to adults. Primary care plays an important role in efforts to prevent and intervene early in the course of child and adolescent mental health problems. While research with adults has shown the feasibility of integrating mental health care into primary care settings, there have been few studies among children and youth. Evidence remains lacking that integration is feasible in diverse settings, that it improves outcomes, and that methods can be developed to address the mixed symptoms of emerging child/youth problems and their overlap with developmental and parental disorders.
Goals: The purpose of this project is to test the effectiveness of adding a child/youth mental health component into an existing collaborative care program for adult mental health problems. The work will refine a framework for efficient cultural adaption and tailoring of an existing child/youth primary care mental health intervention and then test whether the tailored intervention results in improved child and parent outcomes. The work will also provide evidence about the mechanisms by which those outcomes are achieved and what factors influence uptake of the child/youth component by general practitioners (GPs). These results should be generalizable to low and middle income countries and to underserved areas of the US where there are minimal child mental health resources and family physicians provide the bulk of medical care for children and youth.
Methods: The planned work involves the adaptation/tailoring process followed by a trial with 45 GPs already engaged in collaborative care for adults; the trial will study adding collaborative care for children ages 5-15. GPs will be randomly assigned in groups to begin 6-month control periods involving child mental health screening and referral. They will then receive child/youth training and begin second 6-month periods of screening plus ongoing coaching and booster sessions and collaborative management. Primary outcomes will be measured by recruiting and following for 6 months two cohorts of children/youth and their parents (one control, one collaborative care). Data collected from GPs, parents, youth, and the collaborative care data system will allow measurement of key factors that determine the program's success in helping children and families.
연구 개요
상태
상세 설명
Most mental health problems begin in childhood and adolescence, but delays in receipt of treatment are measured in years to decades. As a result, mental health problems cause a disproportionate burden of disability among children and youth compared to adults, and have a major impact on life course development. Primary care services can play an important role in efforts to prevent and intervene early in the course of child and adolescent mental health problems. Primary care services are widely available and offer an opportunity to interact simultaneously with children and their parents, treat mental health in the context of medical and developmental concerns, and reduce the stigma associated with visiting identifiable mental health facilities. While research with adults has shown the feasibility of integrating mental health care into primary care settings, and that it reduces the burden of mental illnesses, there have been few studies among children and youth and none that address a combined task-shifting/stepped care model. In addition, evidence remains lacking that integration is feasible in diverse settings, that it improves clinical outcomes, and has the potential to be scaled up.
One essential element of integration is "shifting" first-line mental health engagement and treatment tasks to primary care providers. Task shifting requires mental health interventions that fit both the local context of primary care services and the local nature of the problems seen. To date, most adult and child integration models have targeted single conditions at diagnostic levels and relied on additional co-located personnel to provide treatment. To achieve goals of prevention and early intervention, integration models for children and youth must take into account that the symptoms of emerging child and youth problems often suggest multiple possible disorders and can be co-morbid with developmental and parental disorders. By definition, emerging problems amenable to early intervention are likely to be "subthreshold" and not qualify for treatment in a specialty setting, especially when resources are scarce, even though early intervention holds the promise of preventing progression.
The purpose of this trial is to test the effectiveness of adding a child/youth mental health component - tailored to fit the context of primary care into an existing collaborative care program supporting primary care management of adult mental health problems.
The trial's specific aims are to conduct an early-stage hybrid effectiveness-implementation trial with 45 general practitioners in two cities focusing on:
- Whether delivery of tailored interventions by primary care providers results in improved child and parent mental health outcomes; and exploring the mechanisms by which the interventions achieve those outcomes (which conditions are more likely to be identified and treated, which treatments have the greatest uptake by parents and youth)
- Whether a coordinated program of training, ongoing coaching, and collaborative care results in uptake of the tailored intervention by primary care providers as evidenced by treatment provided in primary care and participation in collaborative care through consultation and referral.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Tehran, 이란, 이슬람 공화국, 13334
- Tehran University of Medical Sciences
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Brought by parent to see general practitioner
Exclusion Criteria:
- Child is acutely physically ill, in acute pain, or general practitioner feels family should not be approached about the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Control
Children enrolled during the control phase will receive care under the Current collaborative care protocol.
Participating general practitioners are currently trained to recognize child mental health problems and refer them to partner community mental health centers for treatment.
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General practitioners have been trained to recognize children's mental health problems and to refer them to a partner community mental health center.
They receive feedback about the referral but are not encouraged to take on care for the child themselves.
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실험적: Intervention
Children enrolled during the intervention phase will receive Training in management of children's mental health problems.
This will involve treatment by their general practitioner in collaboration with a partner community mental health center; children meeting certain criteria for severity, or whose parents prefer center treatment, will be immediately referred.
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General practitioners will be trained using internationally-developed materials, including the World Health Organization's "mental health need/service gap (mhGAP)" materials and others, adapted for the trial setting (based on formative work that is part of the project).
They will be assisted and monitored as part of the ongoing collaborative care program in which they are participating.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in child mental health-related symptoms
기간: 6 months post enrollment
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Change from baseline to 6-month follow-up on total symptom score of Strengths and Difficulties Questionnaire
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6 months post enrollment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in child mental health-related functioning
기간: 6 months post enrollment
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Change from baseline to 6-month follow-up on "Impact supplement" score of Strengths and Difficulties Questionnaire
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6 months post enrollment
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Change in maternal mental health-related symptoms
기간: 6 months post enrollment
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Change from baseline to 6-month follow-up on total score of General Health Questionnaire
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6 months post enrollment
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공동 작업자 및 조사자
수사관
- 수석 연구원: Lawrence S Wissow, MD, Johns Hopkins School of Medicine
간행물 및 유용한 링크
일반 간행물
- Sharifi V, Mojtabai R, Shahrivar Z, Alaghband-Rad J, Zarafshan H, Wissow L. Child and Adolescent Mental Health Care in Iran: Current Status and Future Directions. Arch Iran Med. 2016 Nov;19(11):797-804.
- Sharifi V, Shahrivar Z, Zarafshan H, Ashkezary SB, Stuart E, Mojtabai R, Wissow L. Collaborative care for child and youth mental health problems in a middle-income country: study protocol for a randomized controlled trial training general practitioners. Trials. 2019 Jul 8;20(1):405. doi: 10.1186/s13063-019-3467-4.
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB00111549
- R34MH106645-01A1 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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Current collaborative care protocol에 대한 임상 시험
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Major Extremity Trauma Research Consortium완전한
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National Institute of Allergy and Infectious Diseases...Institut National de la Santé Et de la Recherche Médicale, France; The Ministry of Health... 그리고 다른 협력자들완전한