Mental Disorder in AdolescenceNCT06403813
Adolescent Digital Mental Health-Kenya Effectiveness
A study testing mHealth Toolkit for Screening & Empowering Lives of Youth (mSELY-A) for Adolescents and mHealth Toolkit for Screening & Empowering Lives of Youth (mSELY-P) for Parents in people with Mental Disorder in Adolescence, run by NYU Langone Health at 1 site in Kenya.
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… Read more about this study
- Who is it for?
- Ages 11 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder in Adolescence
- What is being tested?
- mHealth Toolkit for Screening & Empowering Lives of Youth (mSELY-A) for Adolescents and mHealth Toolkit for Screening & Empowering Lives of Youth (mSELY-P) for Parents
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 563 participants
- Where
- 1 siteKenya
- Study dates
- 22 Apr 2024to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Parents (including biological and non-biological) who have no contact with adolescents for over 1 month
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- mHealth Toolkit for Screening & Empowering Lives of Youth (mSELY-A) for Adolescents, mHealth Toolkit for Screening & Empowering Lives of Youth (mSELY-P) for Parents, Control Tooklit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth Toolkit for Screening & Empowering Lives of Youth (mSELY-A) for AdolescentsBehavioural
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 ParentsBehavioural
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 TooklitOther
The toolkit will have the same screening questions, with information, but without any decision support functions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start22 Apr 2024
- Primary completion14 Nov 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Disorder in AdolescenceStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Keng-Yen Huang, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403813
- Sponsor's protocol ID
- 23-01092
- Other IDs
- 5R21MH124149
- Status last verified
- Mar 2026
- First submitted
- 3 May 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: keng-yen.huang@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06403813
- Acronym / sponsor ID
- 23-01092
- Conditions
- Mental Disorder in Adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 14 Nov 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: Control TooklitParticipating 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. |
| mSELY-A intervention | Experimental | Behavioral: mHealth Toolkit for Screening & Empowering Lives of Youth (mSELY-A) for AdolescentsParticipating 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. |
| mSELY-P intervention | Experimental | Behavioral: mHealth Toolkit for Screening & Empowering Lives of Youth (mSELY-P) for ParentsParticipating 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. |
| mSELY-A and mSELY-P intervention | Experimental | 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 ParentsParticipating 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. |
Who may qualify
- Ages
- 11 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Parents (including biological and non-biological) who have no contact with adolescents for over 1 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth Toolkit for Screening & Empowering Lives of Youth (mSELY-A) for AdolescentsmSELY 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). | Behavioural | mSELY-A and mSELY-P intervention, mSELY-A intervention |
| mHealth Toolkit for Screening & Empowering Lives of Youth (mSELY-P) for ParentsmSELY 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). | Behavioural | mSELY-A and mSELY-P intervention, mSELY-P intervention |
| Control TooklitThe toolkit will have the same screening questions, with information, but without any decision support functions. | Other | Control |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: keng-yen.huang@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keng-Yen Huang, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Toolkit for Screening & Empowering Lives of Youth (mSELY-A) for Adolescents and mHealth Toolkit for Screening & Empowering Lives of Youth (mSELY-P) for Parents in people with Mental Disorder in Adolescence, run by NYU Langone Health at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Universal mental health literacy scale for adolescents (UMHL-A Part A) attitude score (time frame: Baseline, Month 5). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.