Adolescent Digital Mental Health-Kenya Effectiveness

NCT06403813 | Completed

• 2 other identifiers: 23-010925R21MH124149
• Study Type: interventional
• Target: 563
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorder in Adolescence

Outcome Measures

Primary Outcomes (14)

• Change in Universal mental health literacy scale for adolescents (UMHL-A Part A) attitude score

  The UMHL-A Part A consists of 8-items to assess adolescents attitude toward mental health. Each item on the measure is rated on a 5-point scale (1=strongly disagree; 2=disagree; 3=neither agree nor disagree; 4=agree; and 5=strongly agree) with a range in score from 8 to 40 with higher scores indicating a more positive attitude toward mental health.

  Baseline, Month 5

• Change in Parents Universal mental health literacy scale (UMHL) Part A attitude score

  The UMHL Part A consists of 8-items to assess parents attitude such as help seeking and stigma regarding mental health. Each item on the measure is rated on a 5-point scale (1=strongly disagree; 2=disagree; 3=neither agree nor disagree; 4=agree; and 5=strongly agree) with a range in score from 8 to 40 with higher scores indicating a more positive attitude toward mental health.

  Baseline, Month 5

• Change in UMHL-A Part B knowledge score

  The Universal mental health literacy scale for adolescents (UMHL-A) Part B consists of 9-items to assess adolescents mental health knowledge. Each item is rated on a scale (1=yes; 2=no, 0=I don't know). Scores can range from 0 to 18, higher scores indicate mental health illiteracy.

  Baseline, Month 5

• Change in Parents Universal mental health literacy scale (UMHL) Part B knowledge score

  The UMHL-A Part B consists of 9-items to assess parents mental health knowledge. Each item is rated on a scale (1=strongly agree; 2=disagree, 0=I don't know). Scores can range from 0 to 18, higher scores indicate mental health illiteracy.

  Baseline, Month 5

• Change in Adolescents Mental Health Literacy adapted items questionnaire score

  The adapted items questionnaire consists of 8-items to assess mental health knowledge. Each item on the measure is rated on a 5-point scale (1=never; 2=almost never; 3=sometimes; 4=often; and 5=almost always) with a range in score from 8 to 40 with higher scores indicating mental health literacy.

  Baseline, Month 5

• Change in parents Mental Health Literacy adapted items questionnaire score

  The adapted items questionnaire consists of 8-items to assess parents mental health knowledge regarding their child and family. Each item on the measure is rated on a 5-point scale (1=strongly disagree; 2=disagree; 3=undecided; 4=agree; and 5=strongly agree) with a range in score from 8 to 40 with higher scores indicating mental health literacy.

  Baseline, Month 5

• Change in Adolescents Patient-Reported Outcome Measurement Information System (PROMIS) Anxiety score (Adolescent report)

  The PROMIS Anxiety questionnaire consists of 8-items to assess anxiety adolescents felt within the past seven days. Each item on the measure is rated on a 5-point scale (1=never; 2=almost never; 3=sometimes; 4=often; and 5=almost always) with a range in score from 8 to 40 with higher scores indicating greater severity of anxiety.

  Baseline, Month 5

• Change in Adolescent Patient-Reported Outcome Measurement Information System (PROMIS) Anxiety score (parent report)

  The PROMIS Anger questionnaire consists of 8-items for parents to assess their child's behavior within the past seven days, specifically anxiety. Each item on the measure is rated on a 5-point scale (1=never; 2=almost never; 3=sometimes; 4=often; and 5=almost always) with a range in score from 8 to 40 with higher scores indicating greater severity of anxiety observed.

  Baseline, Month 5

• Change in Adolescents Patient-Reported Outcome Measurement Information System (PROMIS) Anger score (adolescent report)

  The PROMIS Anger questionnaire consists of 5-items to assess adolescents anger within the past seven days. Each item on the measure is rated on a 5-point scale (1=never; 2=almost never; 3=sometimes; 4=often; and 5=almost always) with a range in score from 5 to 25 with higher scores indicating greater severity of anger.

  Baseline, Month 5

• Change in Adolescent Patient-Reported Outcome Measurement Information System (PROMIS) Anger score (parent report)

  The PROMIS Anger questionnaire consists of 5-items for parents to assess their child's behavior within the past seven days, specifically anger. Each item on the measure is rated on a 5-point scale (1=never; 2=almost never; 3=sometimes; 4=often; and 5=almost always) with a range in score from 5 to 25 with higher scores indicating greater severity of anger observed.

  Baseline, Month 5

• Change in Adolescent Patient-Reported Outcome Measurement Information System (PROMIS) Depression score (parent report)

  The PROMIS Depression questionnaire consists of 6-items for parents to assess their child's behavior within the past seven days, specifically depression. Each item on the measure is rated on a 5-point scale (1=never; 2=almost never; 3=sometimes; 4=often; and 5=almost always) with a range in score from 6 to 30 with higher scores indicating greater severity of depression.

  Baseline, Month 5

• Change in Adolescents Strengths and Difficulties Questionnaire (SDQ)- S11-17 Conduct Problem Scale score (Adolescent report)

  The SDQ-S11-17 is a brief 5-item behavioral screening questionnaire for 11-17 year olds to assesses the impact of difficulties on the child's life. Each item is rated on a scale (0=not true; 1=somewhat true, 2=certainly true). Scores can range from 0 to 10 with higher scores indicating increased difficulties.

  Baseline, Month 5

• Change in Adolescent Strengths and Difficulties Questionnaire (SDQ) Conduct Problem Scale (10) S11-17 score (Parent report)

  The SDQ Conduct Problem Scale (10) S11-17 is a brief 5-item behavioral screening questionnaire for parents to assess the their child's behavior over the last six months. Each item is rated on a scale (0=not true; 1=somewhat true, 2=certainly true). Scores can range from 0-10, with higher scores indicating increased difficulties observed.

  Baseline, Month 5

• Change in Adolescent Patient Health Questionnaire (PHQ-9) score (Adolescent Report)

  The Patient Health Questionnaire (PHQ-9) is a self-administered version of the PRIME-MD diagnostic instrument that has been modified for teens (ages 11-17) and consists of 9 items assessing depression. Each item is rated on a scale (0=not at all; 1=several days; 2=more than half the days; 3=nearly every day). Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.

  Baseline, Month 5

Study Arms (4)

Control

SHAM COMPARATOR

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.

Other: Control Tooklit

mSELY-A intervention

EXPERIMENTAL

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.

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

mSELY-P intervention

EXPERIMENTAL

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.

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

mSELY-A and mSELY-P intervention

EXPERIMENTAL

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.

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

Interventions

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

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).

mSELY-A and mSELY-P intervention; mSELY-A intervention

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

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).

mSELY-A and mSELY-P intervention; mSELY-P intervention

Control Tooklit OTHER

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

Control

Eligibility Criteria

• Age: 11 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Nairobi

Nairobi, Kenya

Location

MeSH Terms

Interventions

Mass Screening

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Keng-Yen Huang, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The Kenyan study site personnel who carry out Time 2 family data collection will be masked to intervention conditions.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 8, 2024
• Study Start: April 22, 2024
• Primary Completion: November 14, 2025
• Study Completion: December 15, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to keng-yen.huang@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

KE (1)