Depression DisordersAFLNCT06979479
Effectiveness of the Adapt for Life, Mental Wellness and Suicide Prevention Program
An observational study of Depression Disorders and Suicidality, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Adapt for Life is a mental health and wellbeing program designed to help young people develop healthy behaviors and important life skills to manage stress and mental health challenges. The program is a collaboration between Adapt for Life and Cincinnati Children's Hospital Medical Center. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Depression Disorders, Suicidality
- What is being tested?
- school-based intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,102 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2021to 2 Nov 2026
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Students from 12 high schools in the Greater Cincinnati area. The participants are 8th and 9th-grade students, with a total sample size of 1,102 records. The schools are demographically and socioeconomically paired, and health classes within each school are randomized into control and experimental groups.
Who may be able to join
- Student in 8th-12th grade
Who cannot join
- Non-English Speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Adapt for Life is a mental health and wellbeing program designed to help young people develop healthy behaviors and important life skills to manage stress and mental health challenges. The program is a collaboration between Adapt for Life and Cincinnati Children's Hospital Medical Center.
Purpose of the Study: The primary purpose of the Adapt for Life study is to evaluate the effectiveness of the ADAPT framework in improving mental health outcomes for students. The framework includes steps such as Ask, Describe, Assess, Plan, and Talk, which are designed to help students tackle stress during everyday moments or in times of crisis.
Question the Study is Trying to Answer: The study seeks to answer whether the ADAPT framework can significantly improve students' ability to manage stress, recognize mental health issues, and seek appropriate help. It aims to determine if the program can reduce instances of harmful behaviors and improve overall mental wellbeing among participants.
Read the detailed description
Purpose: The Adapt for Life study aims to evaluate the effectiveness of the ADAPT framework in improving mental health outcomes for students. The framework includes steps such as Ask, Describe, Assess, Plan, and Talk, which are designed to help students manage stress during everyday moments or in times of crisis.
Study Design: This study is a randomized controlled trial involving students from various schools in the Greater Cincinnati Tri-State area. Participants are randomly assigned to either the intervention group, which receives the ADAPT framework training, or the control group, which receives standard mental health education.
Intervention: The ADAPT framework consists of the following components:
Ask: Encouraging students to ask questions and seek help when needed. Describe: Helping students describe their feelings and experiences accurately. Assess: Teaching students to assess their mental health and stress levels. Plan: Guiding students in planning healthy coping strategies. Talk: Promoting open conversations about mental health. Hypothesis: The study hypothesizes that students who receive the ADAPT framework training will show significant improvements in their ability to manage stress, recognize mental health issues, and seek appropriate help compared to those who receive standard mental health education.
Outcome Measures: Primary outcomes include changes in students' self-reported stress levels, mental health awareness, and help-seeking behaviors. Secondary outcomes include reductions in harmful behaviors and improvements in overall mental wellbeing.
Data Collection: Data will be collected through REDCap surveys, interviews, and observational assessments conducted at baseline, post-intervention, and 3 month post-intervention stages.
Analysis: Statistical analyses will be performed to compare the outcomes between the intervention and control groups. Mixed-methods approaches will be used to assess the qualitative and quantitative aspects of the intervention's effectiveness.
Ethical Considerations: The study will adhere to ethical guidelines for research involving human subjects. Informed consent will be obtained from all participants and their guardians. Confidentiality and privacy will be maintained throughout the study.
- Conditions
- Depression Disorders, Suicidality
- Being tested
- school-based intervention
- Keywords
- Mental Health, Wellbeing, Stress Management, ADAPT Framework
- Medical subject headings
- Suicidal Ideation, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
school-based interventionBehavioural
Also called Adapt for Life
AFL is a four-day program aimed at combating the stigma associated with mental health conditions and reducing suicidal ideation among youth. The program focuses on improving knowledge about depression and mental illness, enhancing self-efficacy skills for coping and seeking help, and increasing receptiveness to receiving assistance. Facilitated by mental health experts, the educational curriculum equips youth with the necessary tools to address feelings of hopelessness.
| Study group | Role | What they receive |
|---|---|---|
| Control | These participants took all three surveys before receiving the AFL 4-day course. They instead, were given the AFL 4-day course the following semester. | |
| Experimental | These participants took the baseline survey prior to the AFL 4-day course. They then participated in the AFL 4-day course. Immideately after, they took the post-test survey and a 3 month follow up test, 3 months post. Receives: Behavioral: school-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved self-efficacy
Improved Self-Efficacy:
Definition: Self-efficacy is a student's belief in their ability to effectively manage stress and mental health challenges.
Measurement: It is assessed through self-reported surveys where students rate their confidence in handling stressful situations and their ability to use coping strategies taught in the ADAPT framework.
Survey Questions: Students answer questions about their perceived ability to manage anxiety, cope with academic pressure, and maintain emotional balance.
Criteria: Higher scores on these surveys indicate greater self-efficacy, suggesting that students feel more capable of managing their mental health. This includes their confidence in applying techniques like mindfulness, problem-solving, and seeking support when needed.
Impact: Improved self-efficacy can lead to better academic performance, healthier relationships, and overall enhanced wellbeing.
Measured: Enrollment - 3 Month Follow Up
Improved Help-Seeking Attitudes
Improved Help-Seeking Attitudes:
Definition: Help-seeking attitudes refer to a student's willingness to seek support from peers, educators, or mental health professionals when facing mental health challenges.
Measurement: Evaluated through surveys and interviews where students express their likelihood of seeking help and their comfort level in discussing mental health issues.
Survey Questions: Students answer questions about their willingness to talk to a teacher, counselor, or friend when feeling stressed or overwhelmed.
Criteria: Positive changes are indicated by increased willingness to seek help and greater openness in discussing mental health concerns. Higher scores suggest students are more likely to reach out for support and feel comfortable sharing their struggles.
Impact: Improved help-seeking attitudes can lead to earlier intervention, better mental health outcomes, and a supportive school environment.
Measured: Enrollment - 3 Month Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start11 Nov 2021
- Primary completion1 Jan 2025
- Study completion2 Nov 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression DisordersStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Drew Barzman, MD, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979479
- Sponsor's protocol ID
- 2019-1334
- Acronym
- AFL
- Status last verified
- Nov 2026
- First submitted
- 13 May 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Adapt for Life, Mental Wellness and Suicide Prevention Program
- ClinicalTrials.gov ID
- NCT06979479
- Acronym / sponsor ID
- AFL / 2019-1334
- Conditions
- Depression Disorders, Suicidality
- Keywords
- Mental Health, Wellbeing, Stress Management, ADAPT Framework
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,102 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 2 Nov 2026 (actual)
- First posted
- 20 May 2025 (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.
Adapt for Life is a mental health and wellbeing program designed to help young people develop healthy behaviors and important life skills to manage stress and mental health challenges. The program is a collaboration between Adapt for Life and Cincinnati Children's Hospital Medical Center.
Purpose of the Study: The primary purpose of the Adapt for Life study is to evaluate the effectiveness of the ADAPT framework in improving mental health outcomes for students. The framework includes steps such as Ask, Describe, Assess, Plan, and Talk, which are designed to help students tackle stress during everyday moments or in times of crisis.
Question the Study is Trying to Answer: The study seeks to answer whether the ADAPT framework can significantly improve students' ability to manage stress, recognize mental health issues, and seek appropriate help. It aims to determine if the program can reduce instances of harmful behaviors and improve overall mental wellbeing among participants.
Detailed description
Purpose: The Adapt for Life study aims to evaluate the effectiveness of the ADAPT framework in improving mental health outcomes for students. The framework includes steps such as Ask, Describe, Assess, Plan, and Talk, which are designed to help students manage stress during everyday moments or in times of crisis.
Study Design: This study is a randomized controlled trial involving students from various schools in the Greater Cincinnati Tri-State area. Participants are randomly assigned to either the intervention group, which receives the ADAPT framework training, or the control group, which receives standard mental health education.
Intervention: The ADAPT framework consists of the following components:
Ask: Encouraging students to ask questions and seek help when needed. Describe: Helping students describe their feelings and experiences accurately. Assess: Teaching students to assess their mental health and stress levels. Plan: Guiding students in planning healthy coping strategies. Talk: Promoting open conversations about mental health. Hypothesis: The study hypothesizes that students who receive the ADAPT framework training will show significant improvements in their ability to manage stress, recognize mental health issues, and seek appropriate help compared to those who receive standard mental health education.
Outcome Measures: Primary outcomes include changes in students' self-reported stress levels, mental health awareness, and help-seeking behaviors. Secondary outcomes include reductions in harmful behaviors and improvements in overall mental wellbeing.
Data Collection: Data will be collected through REDCap surveys, interviews, and observational assessments conducted at baseline, post-intervention, and 3 month post-intervention stages.
Analysis: Statistical analyses will be performed to compare the outcomes between the intervention and control groups. Mixed-methods approaches will be used to assess the qualitative and quantitative aspects of the intervention's effectiveness.
Ethical Considerations: The study will adhere to ethical guidelines for research involving human subjects. Informed consent will be obtained from all participants and their guardians. Confidentiality and privacy will be maintained throughout the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –These participants took all three surveys before receiving the AFL 4-day course. They instead, were given the AFL 4-day course the following semester. |
| Experimental | – | Behavioral: school-based interventionThese participants took the baseline survey prior to the AFL 4-day course. They then participated in the AFL 4-day course. Immideately after, they took the post-test survey and a 3 month follow up test, 3 months post. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Students from 12 high schools in the Greater Cincinnati area. The participants are 8th and 9th-grade students, with a total sample size of 1,102 records. The schools are demographically and socioeconomically paired, and health classes within each school are randomized into control and experimental groups.
Key inclusion criteria (1 listed)
- Student in 8th-12th grade
Key exclusion criteria (1 listed)
- Non-English Speaking
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 |
|---|---|---|
| school-based interventionAlso: Adapt for LifeAFL is a four-day program aimed at combating the stigma associated with mental health conditions and reducing suicidal ideation among youth. The program focuses on improving knowledge about depression and mental illness, enhancing self-efficacy skills for coping and seeking help, and increasing receptiveness to receiving assistance. Facilitated by mental health experts, the educational curriculum equips youth with the necessary tools to address feelings of hopelessness. | Behavioural | Experimental |
Primary outcome
Improved self-efficacy
Time frame: Enrollment - 3 Month Follow Up
Improved Self-Efficacy: Definition: Self-efficacy is a student's belief in their ability to effectively manage stress and mental health challenges. Measurement: It is assessed through self-reported surveys where students rate their confidence in handling stressful situations and their ability to use coping strategies taught in the ADAPT framework. Survey Questions: Students answer questions about their perceived ability to manage anxiety, cope with academic pressure, and maintain emotional balance. Criteria: Higher scores on these surveys indicate greater self-efficacy, suggesting that students feel more capable of managing their mental health. This includes their confidence in applying techniques like mindfulness, problem-solving, and seeking support when needed. Impact: Improved self-efficacy can lead to better academic performance, healthier relationships, and overall enhanced wellbeing.
Improved Help-Seeking Attitudes
Time frame: Enrollment - 3 Month Follow Up
Improved Help-Seeking Attitudes: Definition: Help-seeking attitudes refer to a student's willingness to seek support from peers, educators, or mental health professionals when facing mental health challenges. Measurement: Evaluated through surveys and interviews where students express their likelihood of seeking help and their comfort level in discussing mental health issues. Survey Questions: Students answer questions about their willingness to talk to a teacher, counselor, or friend when feeling stressed or overwhelmed. Criteria: Positive changes are indicated by increased willingness to seek help and greater openness in discussing mental health concerns. Higher scores suggest students are more likely to reach out for support and feel comfortable sharing their struggles. Impact: Improved help-seeking attitudes can lead to earlier intervention, better mental health outcomes, and a supportive school environment.
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 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression Disorders and Suicidality, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 1 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 3 Nov 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 United States. 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. 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?
Improved self-efficacy (time frame: Enrollment - 3 Month Follow Up). The study lists 2 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 3 Nov 2026.