NCT03051633

Brief Summary

The goal of this project is to test the effectiveness of a successful anti-drug communications campaign (Be Under your Own Influence) to lower substance use among AI 7th graders. The campaign uses messages that support youths' personal autonomy and future aspirations, and these messages are delivered to 7th graders using high school students. Our goal is to develop a turnkey package for the broader population of AI youth and schools and to develop components that can incorporate flexibility and creativity in their delivery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
528

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

April 15, 2014

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 14, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2018

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

August 3, 2020

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2020

Enrollment Period

4.1 years

First QC Date

February 8, 2017

Results QC Date

April 9, 2020

Last Update Submit

July 20, 2020

Conditions

Adolescent Substance Use

Outcome Measures

Primary Outcomes (3)

  • Alcohol Initiation

    The number of students who self-reported initiated alcohol for the first time during the study period

    18 months

  • Alcohol Intoxication Initiation

    Number of participants self-reporting first-time alcohol intoxication initiation during the study period.

    18 months

  • Marijuana Initiation

    Number of participants who self-reported first-time marijuana use initiation during the study period

    18 months

Study Arms (2)

Be Under Your Own Influence Intervention

EXPERIMENTAL

School-based anti-substance use communications campaign

Behavioral: Be Under Your Own Influence

Control

NO INTERVENTION

Assessment only

Interventions

Be Under Your Own InfluenceBEHAVIORAL

School based anti-drug use communications campaign

Be Under Your Own Influence Intervention

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Attend 7th grade in targeted schools that are on or near American Indian reservation and have received parental consent

You may not qualify if:

  • No parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Results Point of Contact

Title
Dr. Meghan Crabtree
Organization
Colorado State University
meghan.crabtree@colostate.edu
2105875584

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

February 8, 2017

First Posted

February 14, 2017

Study Start

April 15, 2014

Primary Completion

May 16, 2018

Study Completion

May 16, 2018

Last Updated

August 3, 2020

Results First Posted

August 3, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share