NCT02584621

Brief Summary

The proposed study is a randomized controlled trial that compares the effectiveness of an electronic personalized health screening app incorporating motivational feedback (i.e. "Check Yourself") to usual care among moderate to high risk alcohol users. The purpose of this study is to determine whether Check Yourself is more effective than usual care in reducing alcohol consumption and binge drinking and improving quality of care among adolescents receiving school-based health clinic services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

October 5, 2017

Status Verified

October 1, 2017

Enrollment Period

1.3 years

First QC Date

October 21, 2015

Last Update Submit

October 4, 2017

Conditions

Alcohol Risk BehaviorsHealth Care Services Quality of Care

Outcome Measures

Primary Outcomes (2)

  • Alcohol Use Frequency and Quantity

    Adolescent reported level for alcohol risk behaviors at 2 months adjusting for baseline level. Specific alcohol behaviors include: 1) number of days in which alcohol was consumed in the past 30 days; 2) number of alcoholic drinks typically consumed per occasion; and 4) maximum number of alcoholic drinks consumed during one drinking episode.

    2 months

  • Adolescent report of whether alcohol was counseled on during health provider visit

    1 day

Secondary Outcomes (5)

  • Marijuana Use Frequency and Quantity

    2 months

  • Adolescent Satisfaction with Care

    1 day

  • Interval Receipt of Care for Substance Use

    2 months

  • Adolescent Substance Use Problem Recognition

    1 day & 2 months

  • Motivation for Substance Use Behavior Change

    1 day & 2 months

Other Outcomes (3)

  • Number of non-substance use health risk behaviors

    2 months

  • Adolescent perceived support from their health care provider

    1 day

  • Adolescent report of whether marijuana/other drug use was counseled on during health provider visit

    1 day

Study Arms (2)

Check Yourself App With Feedback

EXPERIMENTAL

Participants complete Check Yourself, an electronic health screening app and receive personalized, motivational feedback on their health behaviors prior to their visit with their health provider. Key components of Check Yourself include the provision of age normative feedback, goal setting strategies, and strategies to highlight discrepancies. Health providers receive a summary report of health risk behaviors from Check Yourself prior to the visit.

Behavioral: Check Yourself App with Feedback

Usual Care

NO INTERVENTION

Participants are asked to complete health risk screening questions on a tablet computer. No personalized feedback is provided to adolescents and primary care providers do not receive a summary report of the adolescent's health risk behaviors.

Interventions

Check Yourself App with FeedbackBEHAVIORAL
Check Yourself App With Feedback

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Eligible individuals will be 13-18 years old who are able to read and comprehend English.
  • Participants who indicate alcohol use consistent with moderate to high risk on the Check Yourself App.

You may not qualify if:

  • Individuals will be excluded from the study if:
  • They do not meet age requirements
  • Do not have a study visit at a participating school-based health clinic
  • Lack the means to complete follow-up interviews (i.e. have neither telephone or internet access)
  • Are not able to read or comprehend English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Interagency Teen Health Center

Seattle, Washington, 98118, United States

Location

Garfield Teen Health Center

Seattle, Washington, 98122, United States

Location

Nathan Hale Teen Health Center

Seattle, Washington, 98125, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 21, 2015

First Posted

October 22, 2015

Study Start

November 1, 2015

Primary Completion

February 1, 2017

Study Completion

April 1, 2017

Last Updated

October 5, 2017

Record last verified: 2017-10

Locations

US(3)