NCT02680899

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

3 months

First QC Date

February 2, 2016

Last Update Submit

November 28, 2017

Conditions

Mental DisordersSubstance-Related DisordersSocial StigmaMental Health Wellness 1Mental Health Impairment

Keywords

science educationhealth promotionmental health promotionstigmatizationbehavioral intervention

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Teacher Report of Student Outcomes

    Conducted at study completion, estimated to be ~1 month

Study Arms (1)

Curricular Intervention

EXPERIMENTAL

The intervention is a novel science education curriculum in mental health and addiction called My Mind, My Body.

Behavioral: Curricular Intervention

Interventions

Curricular InterventionBEHAVIORAL

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

Curricular Intervention

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Yang J, Lopez Cervera R, Tye SJ, Ekker SC, Pierret C. Adolescent mental health education InSciEd Out: a case study of an alternative middle school population. J Transl Med. 2018 Apr 3;16(1):84. doi: 10.1186/s12967-018-1459-x.

    PMID: 29615090DERIVED

MeSH Terms

Conditions

Mental DisordersSubstance-Related DisordersSocial StigmaStereotyping

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersSocial BehaviorBehavior

Study Officials

  • Christopher Pierret, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Stephen C Ekker, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Joanna Yang, BS

    Mayo Clinic

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Biochemistry and Molecular Biology

Study Record Dates

First Submitted

February 2, 2016

First Posted

February 12, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

November 30, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)