Clinical trial NCT06403813: Adolescent Digital Mental Health-Kenya Effectiveness
Official title: Testing the Effectiveness of a Digital Adolescent Behavioral Health Screening, Literacy, and Low-Intensity Intervention for Common Adolescent Mental Health Problems in Kenya
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Disorder in Adolescence
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-05-08
Enrollment: 600
Sex: ALL
Minimum age (years): 11
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change in Universal mental health literacy scale for adolescents (UMHL-A Part A) attitude score
timeFrame: Baseline, Month 5
measure: Change in Parents Universal mental health literacy scale (UMHL) Part A attitude score
timeFrame: Baseline, Month 5
measure: Change in UMHL-A Part B knowledge score
timeFrame: Baseline, Month 5
measure: Change in Parents Universal mental health literacy scale (UMHL) Part B knowledge score
timeFrame: Baseline, Month 5
measure: Change in Adolescents Mental Health Literacy adapted items questionnaire score
timeFrame: Baseline, Month 5
measure: Change in parents Mental Health Literacy adapted items questionnaire score
timeFrame: Baseline, Month 5
measure: Change in Adolescents Patient-Reported Outcome Measurement Information System (PROMIS) Anxiety score (Adolescent report)
timeFrame: Baseline, Month 5
measure: Change in Adolescent Patient-Reported Outcome Measurement Information System (PROMIS) Anxiety score (parent report)
timeFrame: Baseline, Month 5
measure: Change in Adolescents Patient-Reported Outcome Measurement Information System (PROMIS) Anger score (adolescent report)
timeFrame: Baseline, Month 5
measure: Change in Adolescent Patient-Reported Outcome Measurement Information System (PROMIS) Anger score (parent report)
timeFrame: Baseline, Month 5
measure: Change in Adolescent Patient-Reported Outcome Measurement Information System (PROMIS) Depression score (parent report)
timeFrame: Baseline, Month 5
measure: Change in Adolescents Strengths and Difficulties Questionnaire (SDQ)- S11-17 Conduct Problem Scale score (Adolescent report)
timeFrame: Baseline, Month 5
measure: Change in Adolescent Strengths and Difficulties Questionnaire (SDQ) Conduct Problem Scale (10) S11-17 score (Parent report)
timeFrame: Baseline, Month 5
measure: Change in Adolescent Patient Health Questionnaire (PHQ-9) score (Adolescent Report)
timeFrame: Baseline, Month 5
Secondary outcomes:
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: University of Nairobi
Study officials:
affiliation: NYU Langone Health
name: Keng-Yen Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References: