Clinical trial NCT05476237: Adolescent Depression Screening and Treatment in Mozambican Primary Care
Official title: Pilot Implementation of Depression Screening and Treatment for Adolescents in Mozambican Primary Care
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression
Adolescent Behavior
Keywords: adolescent depression
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-07-27
Enrollment: 114
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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).

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.

Eligibility criteria: Inclusion Criteria:

1. Providers:

   1. 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.
   2. 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.
2. Patients: In both study arms, adolescents attending one of the four study YFHS will be included in the study if they:

   1. are between the ages of 12-19 years;
   2. screen positive for depression;
   3. provide informed consent (ages 16 -19) or if their guardian provides informed consent and they provide assent (if ages 12-15).
3. Study centers: must be clinics that have YFHS.

Exclusion Criteria:

In both study arms, adolescents will be excluded if they:

1. are unable to participate in treatment due to acute illness; and/or
2. are unable to communicate sufficiently in Portuguese to answer inclusion questions.

Primary outcomes:
measure: PHQ-A results
timeFrame: 6 months
measure: IPT-AG Fidelity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Maputo
country: Mozambique
facility: Centro de Saude Alto Mae
city: Maputo
country: Mozambique
facility: Centro de Saude Chamaculo
city: Maputo
country: Mozambique
facility: Centro de Saude Magoanine Tendas
city: Maputo
country: Mozambique
facility: Centro de Saude Primeiro de Maio
Study officials:
affiliation: Columbia University
name: Kathryn Lovero, PhD
role: PRINCIPAL_INVESTIGATOR
References: