- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05476237
Adolescent Depression Screening and Treatment in Mozambican Primary Care
July 14, 2023 updated by: Kathryn L. Lovero, PhD, Columbia University
Pilot Implementation of Depression Screening and Treatment for Adolescents in Mozambican Primary Care
This is a cluster-randomized pilot trial of depression screening and treatment implementation at four Youth-friendly Health Services (YFHS) in primary care clinics, two in Maputo City and two in Maputo Province.
YFHS will be stratified by urbanicity, such that one YFHS in Maputo City and one YFHS in Maputo Province will be randomized to interpersonal psychotherapy (IPT)-A and the other YFHS in each location with be randomized to treatment as usual (TAU).
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
Mental disorders are the leading cause of disability among adolescents worldwide, but only a very small minority, mostly in high-resource settings, have access to mental health care.
The investigators' work is focused on understanding how to increase access to mental health care for adolescents in low-resource settings.
In Mozambique, where this work is based, there are just 15 psychiatrists and 180 psychologists to serve its population of 29 million.
In collaboration with local stakeholders, including governmental policymakers and primary care providers, the investigators developed a plan to implement care for adolescent depression in primary care settings.
The investigators now aim to examine changes in adolescent depression and acceptability of primary care-based mental health services compared to treatment as usual.
Study Type
Interventional
Enrollment (Estimated)
114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Palmira Dos Santos, PhD
- Phone Number: 00258825944524
- Email: palmira_fortunato@yahoo.com.br
Study Contact Backup
- Name: Kathryn Lovero, PhD
- Phone Number: (858)2542979
- Email: kll2153@cumc.columbia.edu
Study Locations
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Maputo, Mozambique
- Centro de Saude Alto Mae
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Contact:
- Palmira dos Santos, PhD
- Phone Number: +258825944524
- Email: palmira_fortunato@yahoo.com.br
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Maputo, Mozambique
- Centro de Saude Chamaculo
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Contact:
- Palmira dos Santos, PhD
- Phone Number: +258825944524
- Email: palmira_fortunato@yahoo.com.br
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Maputo, Mozambique
- Centro de Saude Magoanine Tendas
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Contact:
- Palmira dos Santos, PhD
- Phone Number: +258825944524
- Email: palmira_fortunato@yahoo.com.br
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Maputo, Mozambique
- Centro de Saude Primeiro de Maio
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Contact:
- Palmira dos Santos, PhD
- Phone Number: +258825944524
- Email: palmira_fortunato@yahoo.com.br
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 19 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Providers:
- IPT-AG Arm: YFHS staff will be included in the study if they (a) conduct screening for depression and/or group IPT-AG and (b) provide consent to participate in the study.
- TAU Arm: YFHS staff will be included in the study if they (a) provide referrals for adolescents suspected of having mental illness or seeking mental health services and (b) provide consent to participate in the study. Treatment providers (Psychiatric Technicians and psychologists) will be included in the study if they (a) treat adolescents referred from participating YFHS for depression and (b) provide consent to participate in the study.
Patients: In both study arms, adolescents attending one of the four study YFHS will be included in the study if they:
- are between the ages of 12-19 years;
- screen positive for depression;
- provide informed consent (ages 16 -19) or if their guardian provides informed consent and they provide assent (if ages 12-15).
- Study centers: must be clinics that have YFHS.
Exclusion Criteria:
In both study arms, adolescents will be excluded if they:
- are unable to participate in treatment due to acute illness; and/or
- are unable to communicate sufficiently in Portuguese to answer inclusion questions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: TAU
Psychologists or PsyTechs in mental health services of primary care clinics will provide individual psychotherapy to depressed adolescents in the TAU arm.
Local mental health professionals providing depression treatment in the TAU arm will not have been trained on IPT for adults or adolescents.
Also, the two Ministry of Health psychologists trained as trainers of IPT-AG will not provide treatment in the TAU Arm.
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Adolescents will be administered unstructured psychotherapy in individual sessions with a trained mental health specialist (i.e., psychologist or psychiatric technician).
Other Names:
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Experimental: IPT-AG
Group IPT-AG will be facilitated by the trained providers at each YFHS using the IPT-AG manual adapted to the Mozambican context.
Adolescents will participate in 12 weekly sessions.
The first and last sessions will be one-on-one with the provider.
The first session is used for the participant and provider to develop a treatment plan and the last session is to prepare for treatment termination.
All other sessions will be conducted in groups of 6-8 adolescents.
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IPT-AG is a ten session, group therapy for adolescents.
Each group contains 6-8 adolescents who attend weekly sessions together.
The goals of IPT-AG are: 1) to reduce depression symptoms, and 2) to improve interpersonal relationships.
Another aim of the group format is to increase adolescents' experience with positive social interactions and to reduce social isolation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PHQ-A results
Time Frame: 6 months
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The Patient Health Questionnaire (PHQ)-A is a 9-item severity measure of depression for adolescents adapted from the PHQ-9.
Questions ask how often an adolescent has been bothered by different depression symptoms in the past week, and responses of "not at all," "several days," "more than half the days," and "nearly every day" are given scores of 0 to 3. A total score is calculated by summing the value of all items and ranges from 0 (better outcome) to 27 (worse outcome).
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6 months
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IPT-AG Fidelity
Time Frame: 6 months
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The Group IPT-AG Fidelity Checklist is a 14-item scale that measures provider fidelity to group interpersonal therapy for adolescents.
Providers are scored for superior (1), satisfactory (2), or needs improvement (3) adherence to each item on the checklist, which each represent and essential element of treatment (e.g., gives hope that depression is treatable, links depression to interpersonal problems).
The score of the 14-items is averaged to compute the IPT-AG Fidelity rating (1=superior, 2=satisfactory, 3=needs improvement), with 1 indicating a better outcome.
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kathryn Lovero, PhD, Columbia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2023
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
July 25, 2022
First Submitted That Met QC Criteria
July 25, 2022
First Posted (Actual)
July 27, 2022
Study Record Updates
Last Update Posted (Actual)
July 17, 2023
Last Update Submitted That Met QC Criteria
July 14, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAT8351
- K01MH120258 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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