Adolescent Depression Screening and Treatment in Mozambican Primary Care

Depression Clinical Trial

Official title:

Pilot Implementation of Depression Screening and Treatment for Adolescents in Mozambican Primary Care

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05476237
• Other study ID #: AAAT8351
• Secondary ID: K01MH120258
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 114
• Est. completion date: June 30, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Behavior
• Depression
• Depressive Disorder

Intervention

Behavioral:
• Group Interpersonal Therapy for Adolescents (IPT-AG)
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.
• Treatment as Usual (TAU)
Adolescents will be administered unstructured psychotherapy in individual sessions with a trained mental health specialist (i.e., psychologist or psychiatric technician).

Locations

Country	Name	City	State
Mozambique	Centro de Saude Alto Mae	Maputo
Mozambique	Centro de Saude Chamaculo	Maputo
Mozambique	Centro de Saude Magoanine Tendas	Maputo
Mozambique	Centro de Saude Primeiro de Maio	Maputo

Sponsors (2)

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

Country where clinical trial is conducted

Mozambique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PHQ-A results	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).	6 months
Primary	IPT-AG Fidelity	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.	6 months