Collaborative Care for Children’s Mental Health Problems

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Brief Title

Collaborative Care for Children's Mental Health Problems

Official Title

Collaborative Child Mental Healthcare in Low-Resource Settings

Brief Summary

      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.
    

Detailed Description

      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:

        1. 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)

        2. 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.
    


Study Type

Interventional


Primary Outcome

Change in child mental health-related symptoms

Secondary Outcome

 Change in child mental health-related functioning

Condition

Depression

Intervention

Training in management of children's mental health problems

Study Arms / Comparison Groups

 Control
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

1111

Start Date

August 1, 2017

Completion Date

September 30, 2019

Primary Completion Date

September 30, 2019

Eligibility Criteria

        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.
      

Gender

All

Ages

5 Years - 15 Years

Accepts Healthy Volunteers

No

Contacts

Lawrence S Wissow, MD, , 

Location Countries

Iran, Islamic Republic of

Location Countries

Iran, Islamic Republic of

Administrative Informations


NCT ID

NCT03144739

Organization ID

IRB00111549

Secondary IDs

R34MH106645-01A1

Responsible Party

Sponsor

Study Sponsor

Johns Hopkins University

Collaborators

 National Institute of Mental Health (NIMH)

Study Sponsor

Lawrence S Wissow, MD, Principal Investigator, Johns Hopkins School of Medicine


Verification Date

October 2019