MedPath

Five-Arm Shamiri Trial

Phase 3
Recruiting
Conditions
Mental and Behavioural Disorders
Registration Number
PACTR202104716135752
Lead Sponsor
Templeton World Charity Foundation
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
1288
Inclusion Criteria

Participants must be aged between 12 and 21
Participants are high school students attending a high school in Kenya.

Exclusion Criteria

There are no other exclusion criteria beyond the inclusion criteria listed above.
Should more participants meet the inclusion criteria than is logistically feasible for the indicated group sizes and numbers of group leaders, participants (who have met the inclusion criteria) will be randomly selected to take part in the program.
This is a universal intervention, so the youth do not need to meet a symptom threshold.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes in self-reported depression symptoms as measured by the Patient Health Questionnaire - 8;Changes in self-reported anxiety symptoms, measured by the Generalized Anxiety Disorder Screener ;Changes in average academic grade from school-term before participation to school-term after participation, as measured by the average grade achieved by student across all enrolled students. As participants will be students from various classes and in various schools, student average grades will be rescaled, a mean of 60 and SD of 10 will be used in rescaling.;Changes in the mental well-being of participants measured by the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath