Trial Outcomes & Findings for Adolescent Depression Screening and Treatment in Mozambican Primary Care (NCT NCT05476237)
NCT ID: NCT05476237
Last Updated: 2026-02-27
Results Overview
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.
COMPLETED
NA
95 participants
Baseline, 6 months
2026-02-27
Participant Flow
Unit of analysis: primary care clinic
Participant milestones
| Measure |
Interpersonal Therapy for Adolescents (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.
|
Treatment as Usual (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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|---|---|---|
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Overall Study
STARTED
|
83 2
|
12 2
|
|
Overall Study
COMPLETED
|
83 2
|
12 2
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adolescent Depression Screening and Treatment in Mozambican Primary Care
Baseline characteristics by cohort
| Measure |
Interpersonal Therapy for Adolescents (IPT-AG)
n=83 Participants
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.
|
Treatment as Usual (TAU)
n=12 Participants
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.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
17.4 years
STANDARD_DEVIATION 1.5 • n=24 Participants
|
16.1 years
STANDARD_DEVIATION 2.2 • n=20 Participants
|
17.3 years
STANDARD_DEVIATION 1.65 • n=40 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=24 Participants
|
12 Participants
n=20 Participants
|
95 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
83 Participants
n=24 Participants
|
12 Participants
n=20 Participants
|
95 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
Mozambique
|
83 participants
n=24 Participants
|
12 participants
n=20 Participants
|
95 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsThe 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.
Outcome measures
| Measure |
Interpersonal Therapy for Adolescents (IPT-AG)
n=83 Participants
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.
|
Treatment as Usual (TAU)
n=12 Participants
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.
|
|---|---|---|
|
Change in PHQ-A Score From Baseline to 6 Months Post-intervention
|
-35.9 percent change
Standard Deviation 4.52
|
-54.0 percent change
Standard Deviation 8.5
|
PRIMARY outcome
Timeframe: 6 months post-interventionPopulation: This outcome was only assessed in participants randomized to the IPT-AG arm.
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.
Outcome measures
| Measure |
Interpersonal Therapy for Adolescents (IPT-AG)
n=83 Participants
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.
|
Treatment as Usual (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.
|
|---|---|---|
|
IPT-AG Fidelity
|
1.3 score on a scale
Standard Deviation 0.56
|
—
|
Adverse Events
Interpersonal Therapy for Adolescents (IPT-AG)
Treatment as Usual (TAU)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Interpersonal Therapy for Adolescents (IPT-AG)
n=83 participants at risk
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.
|
Treatment as Usual (TAU)
n=12 participants at risk
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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Psychiatric disorders
Suicidal thoughts
|
24.1%
20/83 • up to 6 months after treatment initiation
|
8.3%
1/12 • up to 6 months after treatment initiation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place