Adolescent Digital Mental Health-Kenya Effectiveness

NYU Langone Health

Status: Enrolling

Conditions: Mental Disorder in Adolescence

Treatments: Behavioral: mHealth Toolkit for Screening & Empowering Lives of Youth (mSELY-P) for Parents; Other: Control Tooklit; Behavioral: mHealth Toolkit for Screening & Empowering Lives of Youth (mSELY-A) for Adolescents

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06403813

5R21MH124149 (U.S. NIH Grant/Contract)

23-01092

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 11 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Adult parent and adolescent child will be enrolled in this study as a family.

Inclusion Criteria:

• Parent is over 18 years of age
• Parent has as an adolescent child between 11-14 years of age who attend one of our partnering schools/community-based organizations (CBOs).
• Parent is willing and able to provide consent for themselves and provide assent for their child
• Adolescent is between 11-14 years in age who attend one of our partnering schools/CBOs.
• One of adolescents adult parent (>18 years old) is "interested in" participating in this study
• Adolescent is willing and able to provide child assent

Exclusion Criteria:

• Parents (including biological and non-biological) who have no contact with adolescents for over 1 month

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 4 patient groups

Control

Sham Comparator group

Description:

Participating schools will be randomly assigned to one of the 4 study arms. Neither the parent or adolescents in the control schools will receive the intervention. Families from the control schools will be given the option to use any other version of Toolkit after completion of the Time 2 post-intervention data collection.

Treatment:

Other: Control Tooklit

mSELY-A intervention

Experimental group

Description:

Participating schools will be randomly assigned to one of the 4 study arms. Only the adolescents from the mSELY-A-alone schools will receive the mSELY-A intervention. Families from these mSELY-A-alone schools will be given the option to use any other version of Toolkit after completion of the Time 2 post-intervention data collection.

Treatment:

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

mSELY-P intervention

Experimental group

Description:

Participating schools will be randomly assigned to one of the 4 study arms. Only the parents from the mSELY-P-alone schools will receive the mSELY-P intervention. Families from these mSELY-P-alone schools will be given the option to use any other version of Toolkit after completion of the Time 2 post-intervention data collection.

Treatment:

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

mSELY-A and mSELY-P intervention

Experimental group

Description:

Participating schools will be randomly assigned to one of the 4 study arms. Both parent and adolescent participants from the mSELY-A+P intervention schools will receive the mSELY-A and mSELY-P intervention.

Treatment:

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

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