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

NCT ID: NCT02840383

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

811 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-05

Study Completion Date

2022-11-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Adolescent School Connectedness Adolescent Health Community Based Participatory Research Methods

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Delayed Intervention

Schools not receiving intervention until two years after implementation.

Group Type ACTIVE_COMPARATOR

Delayed Intervention

Intervention Type OTHER

Schools not receiving intervention until two years after implementation.

Intervention

Schools receiving intervention at the beginning of study.

Group Type EXPERIMENTAL

Intervention

Intervention Type OTHER

intervention at the beginning of study.

Interventions

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Delayed Intervention

Schools not receiving intervention until two years after implementation.

Intervention Type OTHER

Intervention

intervention at the beginning of study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Being unable to participate in the survey
Minimum Eligible Age

14 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

SoLaHmo

UNKNOWN

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michele Allen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota, Department of Family Medicine

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1U01MD010586-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1601S82061

Identifier Type: -

Identifier Source: org_study_id

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