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

Participatory Trial of a Health Promoting School Approach to Positive Youth Development and Wellness Promotion

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

Study Overview

• Status: Completed
• Conditions: Adolescent Health; Adolescent School Connectedness; Community Based Participatory Research Methods
• Intervention / Treatment: Other: Delayed Intervention; Other: Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 811
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Being unable to participate in the survey

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); SoLaHmo
• Investigators: Principal Investigator: Michele Allen, MD, University of Minnesota, Department of Family Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2017
• Primary Completion (Actual): November 20, 2022
• Study Completion (Actual): November 20, 2022

Study Registration Dates

• First Submitted: June 8, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (Estimate): July 21, 2016

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1601S82061; 1U01MD010586-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No