Collaborative Care for Children's Mental Health Problems

Depression Clinical Trial

Official title:

Collaborative Child Mental Healthcare in Low-Resource Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03144739
• Other study ID #: IRB00111549
• Secondary ID: R34MH106645-01A1
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1111
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Attention Deficit and Disruptive Behavior Disorders
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Depression
• Disease
• Oppositional Defiant Disorder
• Parent-Child Relations
• Substance Use

Intervention

Other:
• Training in management of children's mental health problems
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.
• Current collaborative care protocol
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in child mental health-related symptoms	Change from baseline to 6-month follow-up on total symptom score of Strengths and Difficulties Questionnaire	6 months post enrollment
Secondary	Change in child mental health-related functioning	Change from baseline to 6-month follow-up on "Impact supplement" score of Strengths and Difficulties Questionnaire	6 months post enrollment
Secondary	Change in maternal mental health-related symptoms	Change from baseline to 6-month follow-up on total score of General Health Questionnaire	6 months post enrollment