Adolescent Depression Screening and Treatment in Mozambican Primary Care

NCT05476237 | Completed Results DMC

• 2 other identifiers: AAAU3060K01MH120258
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 4

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).

Conditions

Depression; Adolescent Behavior

Keywords

adolescent depression

Outcome Measures

Primary Outcomes (2)

• Change in PHQ-A Score From Baseline to 6 Months Post-intervention

  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). The change in PHQ-A score will be reported as a percent change.

  Baseline, 6 months

• 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). The total score range is 1 to 14, with a lower score indicating a better outcome. This outcome was only assessed in participants who received the study intervention.

  6 months post-intervention

Study Arms (2)

TAU

ACTIVE COMPARATOR

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.

Behavioral: Treatment as Usual (TAU)

IPT-AG

EXPERIMENTAL

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.

Behavioral: Group Interpersonal Therapy for Adolescents (IPT-AG)

Interventions

Group Interpersonal Therapy for Adolescents (IPT-AG) BEHAVIORAL

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.

IPT-AG

Treatment as Usual (TAU) BEHAVIORAL

Adolescents will be administered unstructured psychotherapy in individual sessions with a trained mental health specialist (i.e., psychologist or psychiatric technician).

Also known as: TAU

TAU

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• In both study arms, adolescents will be excluded if they:
• are unable to participate in treatment due to acute illness; and/or

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

Centro de Saude Alto Mae

Maputo, Mozambique

Location

Centro de Saude Chamaculo

Maputo, Mozambique

Location

Centro de Saude Magoanine Tendas

Maputo, Mozambique

Location

Centro de Saude Primeiro de Maio

Maputo, Mozambique

Location

MeSH Terms

Conditions

Depression; Adolescent Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Kathryn Lovero, PhD
• Organization: Columbia University

kll2153@cumc.columbia.edu

(858) 254-2979

Study Officials

• Kathryn Lovero, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Sociomedical Sciences

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 27, 2022
• Study Start: April 1, 2023
• Primary Completion: May 16, 2024
• Study Completion: September 27, 2024
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

MO (4)