Adolescent Digital Mental Health-Kenya Effectiveness

NCT06403813 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 563

Last updated 2026-03-05

No results posted yet for this study

Summary

This study seeks to respond to the growing burden of adolescent mental health disorders and urgent preventive service needs in Kenya by studying the effectiveness of a digital health intervention- mobile health (mHealth) Toolkit for Screening \& Empowering Lives of Youth (mSELY)-that has demonstrated feasibility from our prior pilot study. The investigators will build on this work and examine two versions of mSELY. The mSELY-A is designed for adolescents to self-evaluate and manage psychological wellbeing/mental health needs, as well as to gain resources and access and connect with adolescent peers. The mSELY-P is designed for parents to self-evaluate their adolescent's development and mental health, gain awareness about their adolescent's mental health status, and learn strategies and resources to support adolescents' mental health. Both versions provide screening, tailored mental health literacy materials, and decision support for adolescents and/or their parents. This study will examine the effectiveness of these digital interventions using a randomized control trial with diverse community-based organizations in Kenya. In addition, the investigators will study underlying mechanisms that contribute to intervention effectiveness, as well as to use the data for precision medicine analysis (using machine learning approach). Findings will be used to improve Digital-Toolkit decision support functions and accuracy of mental health precision care.

Conditions

  • Mental Disorder in Adolescence

Interventions

BEHAVIORAL

mHealth Toolkit for Screening & Empowering Lives of Youth (mSELY-A) for Adolescents

mSELY is a preventive intervention tool to be used by adolescents and/or their parents as a self-help support modality. The mSELY-A is designed for adolescents to self-evaluate and manage psychological wellbeing/mental health needs, as well as to gain resources and access and connect with adolescent peers.The mSELY integrates 4 key mental health service functions: i) screening for common mental health problems (anxiety, depression, conduct problems) in adolescents and social-cognitive-behavioral-environmental risks in multiple domains; ii) a strength and weakness profile for adolescents' behaviors (to promote self-awareness); iii) tailored mental health literacy and promotion strategies, and iv) tailored referral resources (ii to iv are to be generated from the i screening results).

BEHAVIORAL

mHealth Toolkit for Screening & Empowering Lives of Youth (mSELY-P) for Parents

mSELY is a preventive intervention tool to be used by adolescents and/or their parents as a self-help support modality. The mSELY-P is designed for parents to self-evaluate their adolescent's development and mental health, gain awareness about their adolescent's mental health status, and learn strategies and resources to support adolescents' mental health. The mSELY integrates 4 key mental health service functions: i) screening for common mental health problems (anxiety, depression, conduct problems) in adolescents and social-cognitive-behavioral-environmental risks in multiple domains; ii) a strength and weakness profile for adolescents' behaviors (to promote self-awareness); iii) tailored mental health literacy and promotion strategies, and iv) tailored referral resources (ii to iv are to be generated from the i screening results).

OTHER

Control Tooklit

The toolkit will have the same screening questions, with information, but without any decision support functions.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Keng-Yen Huang, PhD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-22
Primary Completion
2025-11-14
Completion
2025-12-15

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06403813 on ClinicalTrials.gov