DepressionNCT03144739
Collaborative Care for Children's Mental Health Problems
A study testing Training in management of children's mental health problems and Current collaborative care protocol in people with Depression and Anxiety, run by Johns Hopkins University at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Depression, Anxiety, Attention Deficit Hyperactivity Disorder
- What is being tested?
- Training in management of children's mental health problems and Current collaborative care protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,111 participants
- Where
- 1 siteIran
- Study dates
- 1 Aug 2017to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Brought by parent to see general practitioner
Who cannot join
- Child is acutely physically ill, in acute pain, or general practitioner feels family should not be approached about the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Depression, Anxiety, Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder, Parent-Child Relations, Substance Use
- Being tested
- Training in management of children's mental health problems, Current collaborative care protocol
- Medical subject headings
- Depression, Anxiety Disorders, Attention Deficit Disorder with Hyperactivity, Oppositional Defiant Disorder, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in management of children's mental health problemsOther
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 protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 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. Receives: Other: Current collaborative care protocol |
| Intervention | Experimental | 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. Receives: Other: Training in management of children's mental health problems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child mental health-related symptoms
Change from baseline to 6-month follow-up on total symptom score of Strengths and Difficulties Questionnaire
Measured: 6 months post enrollment
Secondary outcomes (2)
Change in child mental health-related functioning
Change from baseline to 6-month follow-up on "Impact supplement" score of Strengths and Difficulties Questionnaire
Measured: 6 months post enrollment
Change in maternal mental health-related symptoms
Change from baseline to 6-month follow-up on total score of General Health Questionnaire
Measured: 6 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start1 Aug 2017
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- stepped wedge design, hybrid implementation effectiveness
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Lawrence S Wissow, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144739
- Sponsor's protocol ID
- IRB00111549
- Other IDs
- R34MH106645-01A1
- Status last verified
- Oct 2019
- First submitted
- 5 May 2017
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will be provided as part of the National Database for Clinical Trials Related to Mental Illness (NDCT)
Publications
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.
PubMed 27845550Sharifi 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.
PubMed 31287011Sharifi V, Shahrivar Z, Zarafshan H, Ashezary SB, Arabgol F, Khademi M, Jafarinia M, Hajebi A, Abolhassani F, Emami S, Ashkezari AB, Stuart EA, Mojtabai R, Wissow L. Effect of General Practitioner Training in a Collaborative Child Mental Health Care Program on Children's Mental Health Outcomes in a Low-Resource Setting: A Cluster Randomized Trial. JAMA Psychiatry. 2023 Jan 1;80(1):22-30. doi: 10.1001/jamapsychiatry.2022.3989.
PubMed 36449318
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Child Mental Healthcare in Low-Resource Settings
- ClinicalTrials.gov ID
- NCT03144739
- Acronym / sponsor ID
- IRB00111549
- Conditions
- Depression, Anxiety, Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder, Parent-Child Relations, Substance Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,111 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- stepped wedge design, hybrid implementation effectiveness
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Current collaborative care protocolChildren 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. |
| Intervention | Experimental | Other: Training in management of children's mental health problemsChildren 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. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Brought by parent to see general practitioner
Key exclusion criteria (1 listed)
- Child is acutely physically ill, in acute pain, or general practitioner feels family should not be approached about the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training in management of children's mental health problemsGeneral 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. | Other | Intervention |
| Current collaborative care protocolGeneral 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. | Other | Control |
Primary outcome
Change in child mental health-related symptoms
Time frame: 6 months post enrollment
Change from baseline to 6-month follow-up on total symptom score of Strengths and Difficulties Questionnaire
2 secondary outcomes
Change in child mental health-related functioning
Time frame: 6 months post enrollment
Change in maternal mental health-related symptoms
Time frame: 6 months post enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Background: PubMed 27845550Sharifi 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.
- Background: PubMed 31287011Sharifi 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.
- Derived from this study: PubMed 36449318Sharifi V, Shahrivar Z, Zarafshan H, Ashezary SB, Arabgol F, Khademi M, Jafarinia M, Hajebi A, Abolhassani F, Emami S, Ashkezari AB, Stuart EA, Mojtabai R, Wissow L. Effect of General Practitioner Training in a Collaborative Child Mental Health Care Program on Children's Mental Health Outcomes in a Low-Resource Setting: A Cluster Randomized Trial. JAMA Psychiatry. 2023 Jan 1;80(1):22-30. doi: 10.1001/jamapsychiatry.2022.3989.
- Individual participant dataSharing planned: Yes. Will be provided as part of the National Database for Clinical Trials Related to Mental Illness (NDCT)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence S Wissow, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in management of children's mental health problems and Current collaborative care protocol in people with Depression and Anxiety, run by Johns Hopkins University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in child mental health-related symptoms (time frame: 6 months post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03144739, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019.