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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02680899
Other study ID # 15-009107
Secondary ID
Status Completed
Phase N/A
First received February 2, 2016
Last updated November 28, 2017
Start date February 2016
Est. completion date May 2016

Study information

Verified date November 2017
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study herein seeks to determine whether students undergoing InSciEd Out curriculum in mental health and addiction (called My Mind, My Body) experience 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Curricular Intervention
The intervention is a novel grades 7 and 8 InSciEd Out curriculum in mental health and addiction called My Mind, My Body.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline Score on General Help-Seeking Questionnaire at 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
Primary Change from Baseline Score on Westbrook Mental Health Knowledge Test at 1 month The Westbrook Knowledge Test assesses mental health knowledge. Baseline and then at study completion, estimated to be ~1 month
Primary Change from Baseline Score on Adolescent Attribution Questionnaire at 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 Teacher Report of Student Outcomes 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
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