NCT02840383

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
811

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 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

First Submitted

Initial submission to the registry

June 8, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 5, 2017

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2022

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

5.2 years

First QC Date

June 8, 2016

Last Update Submit

February 17, 2023

Conditions

Adolescent School ConnectednessAdolescent HealthCommunity Based Participatory Research Methods

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Delayed Intervention

ACTIVE COMPARATOR

Schools not receiving intervention until two years after implementation.

Other: Delayed Intervention

Intervention

EXPERIMENTAL

Schools receiving intervention at the beginning of study.

Other: Intervention

Interventions

Delayed InterventionOTHER

Schools not receiving intervention until two years after implementation.

Delayed Intervention
InterventionOTHER

intervention at the beginning of study.

Intervention

Eligibility Criteria

Age14 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Being unable to participate in the survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Michele Allen, MD

    University of Minnesota, Department of Family Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2016

First Posted

July 21, 2016

Study Start

September 5, 2017

Primary Completion

November 20, 2022

Study Completion

November 20, 2022

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations

US(1)