Clinical trial NCT06979479: Effectiveness of the Adapt for Life, Mental Wellness and Suicide Prevention Program
Official title: Effectiveness of the Adapt for Life, Mental Wellness and Suicide Prevention Program
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Depression Disorders
Suicidality
Keywords: Mental Health
Wellbeing
Stress Management
ADAPT Framework
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 1102
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Student in 8th-12th grade

Exclusion Criteria:

* Non-English Speaking

Primary outcomes:
measure: Improved self-efficacy
timeFrame: Enrollment - 3 Month Follow Up
measure: Improved Help-Seeking Attitudes
timeFrame: Enrollment - 3 Month Follow Up
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References: