- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02680899
Adolescent Mental Health InSciEd Out
Adolescent Outcomes in Mental Health InSciEd Out
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Integrated Science Education Outreach (InSciEd Out) is one novel program that seeks to promote scientific and health literacy through fostering scientific inquiry. The guiding premise of InSciEd Out's health promotion arm is a concept called Prescription Education (PE), which uses science education as a direct and early intervention for disease behaviors. The underlying hypothesis of InSciEd Out PE is that a student who lives a scientific experience in his or her own voice (undergoes true inquiry-based science) will be empowered to elect healthier behaviors in any targeted health paradigm. PE's proposed mechanism of change is that inquiry-based science catalyzes transitions from knowledge to understanding to attitudes to intents to actual behavioral change.
InSciEd Out partnership with the the school in this study began in Spring of 2013 with a projected health promotion arm targeting mental health and addiction. The current iteration of the partnership commenced in Summer of 2014 under the annual InSciEd Out summer internship. This internship led to creation of grades 7 and 8 curriculum in mental health and addiction. Version 1 of this curriculum was piloted last year. A revised version of the curriculum will be implemented in Spring of 2016. Although there are education-specific metrics for assessment already built into program evaluation of InSciEd Out, there are currently no clinically relevant inventories in place to specifically probe efficacy of the lesson plans upon key mental health outcomes.
The study herein is the establishment of clinically relevant inventories around implemented InSciEd Out curriculum in mental health and addiction (called My Mind, My Body). These inventories are selected to measure student changes in their mental health-related knowledge, attitudes, and help-seeking behavioral intentions. The research group hypothesizes that students undergoing InSciEd Out mental health and addiction curriculum will exhibit pre-post increases in mental health literacy, decreases in mental health stigmatization, and increases in mental health help-seeking behavioral intentions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Partner school students who do not opt out of and assent to the study
Exclusion Criteria: Partner school students opting out of or not assenting to the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Curricular Intervention
The intervention is a novel science education curriculum in mental health and addiction called My Mind, My Body.
|
The intervention is a novel grades 7 and 8 InSciEd Out curriculum in mental health and addiction called My Mind, My Body.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline Score on General Help-Seeking Questionnaire at 1 month
Time Frame: Baseline and then at study completion, estimated to be ~1 month
|
The general help-seeking questionnaire: vignette version (GHSQ-V) will be used to assess help-seeking behavioral intentions.
|
Baseline and then at study completion, estimated to be ~1 month
|
|
Change from Baseline Score on Westbrook Mental Health Knowledge Test at 1 month
Time Frame: Baseline and then at study completion, estimated to be ~1 month
|
The Westbrook Knowledge Test assesses mental health knowledge.
|
Baseline and then at study completion, estimated to be ~1 month
|
|
Change from Baseline Score on Adolescent Attribution Questionnaire at 1 month
Time Frame: Baseline and then at study completion, estimated to be ~1 month
|
The adolescent attribution questionnaire (AQ-8-C) will be used to assess mental illness stigmatization.
|
Baseline and then at study completion, estimated to be ~1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Teacher Report of Student Outcomes
Time Frame: Conducted at study completion, estimated to be ~1 month
|
Teacher quotes from semi-structured interviews concerning student outcomes in mental health knowledge, attitudes, and behaviors will be used to form a student narrative.
|
Conducted at study completion, estimated to be ~1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher Pierret, PhD, Mayo Clinic
- Principal Investigator: Stephen C Ekker, PhD, Mayo Clinic
- Study Director: Joanna Yang, BS, Mayo Clinic
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-009107
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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