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Completed

NCT Number: NCT06403813

Adolescent Digital Mental Health-Kenya Effectiveness

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.

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Key information

Conditions

Mental Disorder in Adolescence

Age range

11 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nairobi

Nairobi, Kenya

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Control Tooklit

Other

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

Primary outcomes

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

    Time frame: Baseline, Month 5

    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.

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

    Time frame: Baseline, Month 5

    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.

  3. Change in UMHL-A Part B knowledge score

    Time frame: Baseline, Month 5

    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.

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

    Time frame: Baseline, Month 5

    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.

  5. Change in Adolescents Mental Health Literacy adapted items questionnaire score

    Time frame: Baseline, Month 5

    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.

  6. Change in parents Mental Health Literacy adapted items questionnaire score

    Time frame: Baseline, Month 5

    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.

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

    Time frame: Baseline, Month 5

    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.

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

    Time frame: Baseline, Month 5

    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.

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

    Time frame: Baseline, Month 5

    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.

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

    Time frame: Baseline, Month 5

    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.

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

    Time frame: Baseline, Month 5

    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.

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

    Time frame: Baseline, Month 5

    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.

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

    Time frame: Baseline, Month 5

    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.

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

    Time frame: Baseline, Month 5

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Testing the Effectiveness of a Digital Adolescent Behavioral Health Screening, Literacy, and Low-Intensity Intervention for Common Adolescent Mental Health Problems in Kenya

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 8, 2024
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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