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Trial of a Health Promoting School Approach to Positive Youth Development and Wellness Promotion (TRUST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02840383
Recruitment Status : Active, not recruiting
First Posted : July 21, 2016
Last Update Posted : October 22, 2020
Sponsor:
Collaborators:
National Institute on Minority Health and Health Disparities (NIMHD)
SoLaHmo
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
Assess the effects of a school-based multi-component intervention on school connectedness, school engagement, and developmental assets through a group randomized, participatory trial.

Condition or disease Intervention/treatment Phase
Adolescent School Connectedness Adolescent Health Community Based Participatory Research Methods Other: Delayed Intervention Other: Intervention Not Applicable

Detailed Description:

Health Promoting Schools intervention including pilot-tested teacher professional development, student-defined enhanced environment, and parent-defined enhanced community/family connection. The Coalition will finalize the intervention using a phased intervention map that integrates community perspectives with theoretical approaches to evidence based practices. The study aims will be accomplished through a group randomized trial in 10 urban schools with diverse populations representing approximately 1,900 students.

Aim 1: Assess the effects of a school-based multi-component intervention on school connectedness, school engagement, and developmental assets through a group randomized, participatory trial.

Hypothesis 1a: Students in the intervention schools will experience improved school connectedness, engagement and developmental assets compared to the control group.

Aim 2: Assess the effects of a school-based multi-component intervention on emotional well-being, tobacco and other substance use, and academic outcomes through a group randomized, participatory trial.

Hypothesis 2a: Students in the intervention schools will experience improved emotional well-being, course completion, attendance, and decreased disciplinary action and substance use compared to the control group.

Aim 3: Evaluate the relationships between participatory factors , school intervention implementation, and study outcomes.

Exploratory hypothesis 3a: Perceptions of quality of collaborative processes will be associated with degree of school intervention implementation and study outcomes.

Exploratory hypothesis 3b: School capacities and context will be associated with school intervention implementation and study outcomes.

Exploratory hypothesis 3c: School capacities and context will mediate the relationship between quality of collaborative processes and school intervention implementation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Participatory Trial of a Health Promoting School Approach to Positive Youth Development and Wellness Promotion
Actual Study Start Date : September 5, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Active Comparator: Delayed Intervention
Schools not receiving intervention until two years after implementation.
Other: Delayed Intervention
Schools not receiving intervention until two years after implementation.

Experimental: Intervention
Schools receiving intervention at the beginning of study.
Other: Intervention
intervention at the beginning of study.




Primary Outcome Measures :
  1. Baseline student school connectivity on a scale of 1-10 [ Time Frame: 5 years ]
    Assess the effects of a school-based multi-component intervention on school connectedness, school engagement, and developmental assets through a group randomized, participatory trial.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 9th grade students
  • enrolled in the school at the time of randomization

Exclusion Criteria:

  • Being unable to participate in the survey

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840383


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota
National Institute on Minority Health and Health Disparities (NIMHD)
SoLaHmo
Investigators
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Principal Investigator: Michele Allen, MD University of Minnesota, Department of Family Medicine
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02840383    
Other Study ID Numbers: 1601S82061
1U01MD010586-01 ( U.S. NIH Grant/Contract )
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No