Community Mental Health ServicesNCT02552056
The Effect of Integrating CAMH Into PHC and Traditional Healers' Practice in Uganda: a Randomized Controlled Trial
A study testing CAMH training in people with Community Mental Health Services, run by University of Bergen.
Trial summary
This randomized controlled trial will compare the effect of a CAMH integration package on yield of CAMH cases compared to non-CAMH integrated sites. It will be conducted among nurses, midwives and clinical officers who provide PHC services to children and adolescents in 42 health centers; and eligible traditional… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Community Mental Health Services
- What is being tested?
- CAMH training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Feb 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1. Public (government health system) 2. No psychiatric nurse allocated
Who cannot join
- mhGAP training in the previous 3 years
About this study
Official title: The Effect of Integrating Child and Adolescent Mental Health Into Primary Health Care and Traditional Healers' Practice: a Randomized Controlled Trial in Eastern Uganda
This randomized controlled trial will compare the effect of a CAMH integration package on yield of CAMH cases compared to non-CAMH integrated sites. It will be conducted among nurses, midwives and clinical officers who provide PHC services to children and adolescents in 42 health centers; and eligible traditional healers.
Read the detailed description
The overall goal of the study is to increase access to mental health services for children and adolescents in Uganda by improving entry through primary health care workers and traditional healers.
The main objective of the study is to measure the effect of integrating child and adolescent mental health (CAMH) into primary health care (PHC) and into traditional healers' services on CAMH case identification in 2 districts in Eastern Uganda, so as to improve entry into mental health services.
The specific objectives are:
- To estimate the effect of CAMH integration into PHC on case identification, measured by the number of new non- epilepsy CAMH diagnoses.
- To assess the feasibility and effect of integrating CAMH into traditional healers practice, measured by the number of CAMH referrals from community to clinics per month.
- To assess the acceptability of CAMH integration among PHC workers and traditional healers
- To estimate the costs associated with the integration of CAMH into PHC and traditional medicine
- Conditions
- Community Mental Health Services
- Being tested
- CAMH training
- Keywords
- Child Adolescent Mental Integration PHC Traditional Healers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAMH trainingOther
Training of PHC workers included in the study for 5 days to screen children and adolescents for CAMH conditions, based in the mhGAP curriculum for non-specialist health providers.
| Study group | Role | What they receive |
|---|---|---|
| CAMH training | Experimental | Intervention clinics will receive a CAMH integration package comprising of:
* Training PHC workers (midwives, nurses and/or clinical officers) on how to screen and refer for CAMH, based on WHO mhGAP implementation guide.
* Support supervision in the clinics to reinforce training and provide on-job support to PHC staff.
* Provision of job aids and training materials Receives: Other: CAMH training |
| No CAMH training | No intervention | Clinics will continue to provide the standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of clinics which recorded at least one non-epilepsy CAMH diagnosis in the intervention compared to the control group.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community Mental Health ServicesStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Akol, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552056
- Sponsor's protocol ID
- HS 1874
- Status last verified
- May 2016
- First submitted
- 14 Sep 2015
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Akol A, Makumbi F, Babirye JN, Nalugya JS, Nshemereirwe S, Engebretsen IMS. Does mhGAP training of primary health care providers improve the identification of child- and adolescent mental, neurological or substance use disorders? Results from a randomized controlled trial in Uganda. Glob Ment Health (Camb). 2018 Sep 10;5:e29. doi: 10.1017/gmh.2018.18. eCollection 2018.
PubMed 30455964
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Integrating Child and Adolescent Mental Health Into Primary Health Care and Traditional Healers' Practice: a Randomized Controlled Trial in Eastern Uganda
- ClinicalTrials.gov ID
- NCT02552056
- Acronym / sponsor ID
- HS 1874
- Conditions
- Community Mental Health Services
- Keywords
- Child Adolescent Mental Integration PHC Traditional Healers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 16 Sep 2015 (estimated)
- 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.
This randomized controlled trial will compare the effect of a CAMH integration package on yield of CAMH cases compared to non-CAMH integrated sites. It will be conducted among nurses, midwives and clinical officers who provide PHC services to children and adolescents in 42 health centers; and eligible traditional healers.
Detailed description
The overall goal of the study is to increase access to mental health services for children and adolescents in Uganda by improving entry through primary health care workers and traditional healers.
The main objective of the study is to measure the effect of integrating child and adolescent mental health (CAMH) into primary health care (PHC) and into traditional healers' services on CAMH case identification in 2 districts in Eastern Uganda, so as to improve entry into mental health services.
The specific objectives are:
- To estimate the effect of CAMH integration into PHC on case identification, measured by the number of new non- epilepsy CAMH diagnoses.
- To assess the feasibility and effect of integrating CAMH into traditional healers practice, measured by the number of CAMH referrals from community to clinics per month.
- To assess the acceptability of CAMH integration among PHC workers and traditional healers
- To estimate the costs associated with the integration of CAMH into PHC and traditional medicine
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAMH training | Experimental | Other: CAMH trainingIntervention clinics will receive a CAMH integration package comprising of: * Training PHC workers (midwives, nurses and/or clinical officers) on how to screen and refer for CAMH, based on WHO mhGAP implementation guide. * Support supervision in the clinics to reinforce training and provide on-job support to PHC staff. * Provision of job aids and training materials |
| No CAMH training | No intervention | –Clinics will continue to provide the standard of care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Public (government health system) 2. No psychiatric nurse allocated
Key exclusion criteria (1 listed)
- mhGAP training in the previous 3 years
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 |
|---|---|---|
| CAMH trainingTraining of PHC workers included in the study for 5 days to screen children and adolescents for CAMH conditions, based in the mhGAP curriculum for non-specialist health providers. | Other | CAMH training |
Primary outcome
Proportion of clinics which recorded at least one non-epilepsy CAMH diagnosis in the intervention compared to the control group.
Time frame: 3 months
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 13 May 2016.
- Derived from this study: PubMed 30455964Akol A, Makumbi F, Babirye JN, Nalugya JS, Nshemereirwe S, Engebretsen IMS. Does mhGAP training of primary health care providers improve the identification of child- and adolescent mental, neurological or substance use disorders? Results from a randomized controlled trial in Uganda. Glob Ment Health (Camb). 2018 Sep 10;5:e29. doi: 10.1017/gmh.2018.18. eCollection 2018.
Related trials for Community Mental Health Services
Not yet recruitingObservational study
A Community-based, Peer-led Counseling Service: A Hybrid Type 3 Effectiveness-implementation Study
Psychological Distress, Stress Psychological
Recruiting
The ENHANCE Project Toolkit
Substance Related Disorder, Drug Overdose
Active, not recruiting
Pre-exposure Prophylaxis (PrEP) for Health
Substance Dependence, HIV (Human Immunodeficiency Virus)
Active, not recruiting
MHE3 Clinical Trial - Overcoming Obstacles
Mental Health Services, Community Mental Health Services
Not yet recruiting
CHW-Enhanced Trauma Recovery
Traumatic Injury, Posttraumatic Stress Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CAMH training in people with Community Mental Health Services, run by University of Bergen.
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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Proportion of clinics which recorded at least one non-epilepsy CAMH diagnosis in the intervention compared to the control group. (time frame: 3 months). 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 NCT02552056, which also lists 1 linked publication.
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 13 May 2016.