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

Adolescent Health Clinical Trial

— TRUST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02840383
• Other study ID #: 1601S82061
• Secondary ID: 1U01MD010586-01
• Status: Completed
• Phase: N/A
• Start date: September 5, 2017
• Est. completion date: November 20, 2022

Study information

• Verified date: February 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 811
• Est. completion date: November 20, 2022
• Est. primary completion date: November 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 16 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Being unable to participate in the survey

Related Conditions & MeSH terms

• Adolescent Health
• Adolescent School Connectedness
• Community Based Participatory Research Methods

Intervention

Other:
• Delayed Intervention
Schools not receiving intervention until two years after implementation.
• Intervention
intervention at the beginning of study.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota	National Institute on Minority Health and Health Disparities (NIMHD), SoLaHmo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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