Adolescent Digital Mental Health-Kenya Effectiveness

Mental Disorder in Adolescence Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06403813
• Other study ID #: 23-01092
• Secondary ID: 5R21MH124149
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: Keng-Yen Huang, PhD
• Phone: 646-501-2879
• Email: Keng-yen.huang[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorder in Adolescence
• Mental Disorders

Intervention

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).
• 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.

Locations

Country	Name	City	State
Kenya	University of Nairobi	Nairobi

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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