Study Overview and IRB Information
Posted On Sep 22, 2017
Study Overview and IRB Information
The Prepare U curriculum is an innovative program that is currently being studied in up to 500 students, aged 13 – 21, in a high-school environment. This study is anticipated to involve minimal risk to the participants during the study and to have essentially no risk of study participant data identification. The study will investigate how students respond to a new health curriculum module designed to specifically educate them about mental, emotional, and social wellness and to equip them with tools to notice, understand, reduce, and seek effective interventions for difficulties within these domains.
The current study will rely on a specialized adolescent convenience sample drawn from West Bloomfield High School. This pool of potential participants is likely to be more representative than many other sample pools typically used in routine social science research, but likely to be less representative of typical high school environments due to the school’s excellent material and staff resources. The choice of location is due to a range of factors including school interest, school support, and the school having sufficient resources to host such a study without any undue disruption to the pedagogical and social responsibilities of the school to its students and the community at large.
The participants will be recruited through the pool of students set to take a health education sequence in the 2017/2018 school year. The students will need to “double opt in” if minors (both parental consent and student assent) or consent as normal if they are already adults. The participants will have reasonable alternatives to participation provided by the school so that any possible concerns about stigma and coercion will be dramatically minimized. The participants will not be remunerated for their time but are expected to experience a direct benefit from participation. The participants will be debriefed and given pertinent contact information both before and after the study.
The study itself will consist of a pre/post evaluation of the changes that occur in the students’ wellbeing and functioning as a result of taking a pilot health class curriculum module designed to assist with mental, emotional, and social wellbeing. The measures used will consist of three (3) brief, but standard, assessments for adolescents and one (1) new instrument that uses a modern interface design that makes it easy to take over a range of electronic devices.
The data derived from the study will be used primarily for The Live Network (TLN) and its curriculum development and evaluation processes as well as to help inform the West Bloomfield High School with information that will assist the school in making data-driven curriculum decisions.
Because of TLN’s commitment to being a mission-based business, TLN will also work with other researchers to see if the data collected can also provide other opportunities for advancing general knowledge and to promote the best social benefit from the data contributed by the participants. The study will help to better understand how adolescents are likely to experience a novel health curriculum module and how they are likely to communicate information about their disposition, personality, mental health, and emotional health via current health assessments and emerging questionnaire designs.
The study will be overseen by the Chief Research Officer at TLN, M. Ellis Jaruzel II, PsyD a licensed clinician with experience conducting, reviewing, and teaching human subjects research. The principal investigator is also current in their NIDA Clinical Trials Network Good Clinical Practices certification.
The study has been approved by an external Institutional Review Board (IRB) that has thoroughly reviewed the study protocol, materials, and procedures, as well as the qualifications of the Principal Investigator overseeing the research. The IRB, Solutions IRB, will also play a role in the ongoing monitoring of the study while it is active.
The Principal Investigator, Dr. M. Ellis Jaruzel II, can be reached in the following ways:
Phone #: (844) 724-LIVE (5483) extension 702
The IRB, Solutions IRB, can be reached in the following ways:
Phone #: (855) 226-4472
Website: http://www.solutionsirb.com/ Prepare U Study Overview and IRB Information