- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01797835
Alcohol Screening in an Ethnically Diverse Sample of Adolescents in Primary Care
July 3, 2019 updated by: RAND
Screening youth in the primary care setting is one way to identify adolescents who may be at-risk for future alcohol problems.
The current study tests the new NIAAA screening guide questions, which ask about friend and adolescent drinking, to see how well these questions work to predict subsequent alcohol use, problems, and involvement in other risk behaviors, such as sexual risk-taking and delinquency.
In addition, the investigators plan to provide a brief motivational intervention for some at-risk teens and see whether alcohol use differs for those teens who receive the intervention and those teens who receive enhanced usual care.
The results of this study have the potential to significantly impact the standard of care for identifying and intervening with at- risk youth in primary care settings.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
294
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
North Hollywood, California, United States, 91605
- Valley Community Clinic
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15215
- UPMC St. Margaret
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria: 1
- 12-18
- speak English
Exclusion Criteria:
- cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Usual Care
Youth in usual care will receive screening for alcohol and drug use.
Those youth who are at risk will have a chance to talk to their provider about their use.
They will also receive an informational brochure.
|
Youth receive a brochure with information on AOD use.
|
|
Experimental: CHAT brief MI intervention
Youth in CHAT will receive screening for alcohol and drug use.
Those youth who are at risk will have a chance to talk to their provider about their use.
In addition, these youth will CHAT.
CHAT is a brief motivational intervention that takes places in the primary care setting.
It is a 15-20 minute intervention for adolescents age 12-18 focused on discussing alcohol and drug use.
They will also receive a booster call one month later to check in on how they are doing.
|
CHAT is one 15-20 minute session delivered in a single PC visit and utilizes motivational interviewing with youth to target alcohol and drug use in primary care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Times Used Alcohol
Time Frame: Past 3 months
|
in the past three months: Number of times used alcohol; The 6-point frequency response scale (0= "Never" to 5= "More than 20 times") was rescaled to a pseudo-continuous variable ranging from 0 to 20 using the mid-point of any range as the new value (e.g.
3-10 times was recoded as 6.5 times).
|
Past 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Times Used Marijuana
Time Frame: Past 3 months
|
number of times used marijuana in the past 3 months; The 6-point frequency response scale (0= "Never" to 5= "More than 20 times") was rescaled to a pseudo-continuous variable ranging from 0 to 20 using the mid-point of any range as the new value (e.g.
3-10 times was recoded as 6.5 times).
|
Past 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elizabeth J D'Amico, PhD, RAND
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- D'Amico EJ, Parast L, Osilla KC, Seelam R, Meredith LS, Shadel WG, Stein BD. Understanding Which Teenagers Benefit Most From a Brief Primary Care Substance Use Intervention. Pediatrics. 2019 Aug;144(2):e20183014. doi: 10.1542/peds.2018-3014. Epub 2019 Jul 11.
- Meredith LS, Seelam R, Stein BD, Parast L, Shadel WG, D'Amico EJ. Adolescents with better mental health have less problem alcohol use six months later. Addict Behav. 2019 Aug;95:77-81. doi: 10.1016/j.addbeh.2019.03.006. Epub 2019 Mar 7.
- D'Amico EJ, Parast L, Shadel WG, Meredith LS, Seelam R, Stein BD. Brief motivational interviewing intervention to reduce alcohol and marijuana use for at-risk adolescents in primary care. J Consult Clin Psychol. 2018 Sep;86(9):775-786. doi: 10.1037/ccp0000332.
- Meredith LS, Ewing BA, Stein BD, Shadel WG, Brooks Holliday S, Parast L, D'Amico EJ. Influence of mental health and alcohol or other drug use risk on adolescent reported care received in primary care settings. BMC Fam Pract. 2018 Jan 9;19(1):10. doi: 10.1186/s12875-017-0689-y.
- D'Amico EJ, Parast L, Meredith LS, Ewing BA, Shadel WG, Stein BD. Screening in Primary Care: What Is the Best Way to Identify At-Risk Youth for Substance Use? Pediatrics. 2016 Dec;138(6):e20161717. doi: 10.1542/peds.2016-1717. Epub 2016 Nov 18.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
August 1, 2018
Study Registration Dates
First Submitted
February 21, 2013
First Submitted That Met QC Criteria
February 22, 2013
First Posted (Estimate)
February 25, 2013
Study Record Updates
Last Update Posted (Actual)
July 17, 2019
Last Update Submitted That Met QC Criteria
July 3, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01AA021786 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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