- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01105416
Emergency Department (ED) Adolescent Alcohol Prevention Intervention
November 3, 2014 updated by: James Linakis Ph.D., Rhode Island Hospital
Emergency Department Based Prevention Intervention to Delay Alcohol Use by Young Adolescents
The aim of the present study is to prevent or delay the initiation of alcohol use among young adolescents being seen in a pediatric emergency department, by enhancing parental monitoring and improving parent/adolescent conversations.
Previous studies have shown that the pediatric emergency department is an excellent location for performing prevention interventions.
By targeting individuals and their families in the pediatric emergency department (PED), we are capitalizing on the opportunity to perform a prevention intervention among a high risk population when parent and youth may be particularly receptive to the intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Our long term goal is to develop, implement, and evaluate a program to prevent or delay the initiation of alcohol use in young adolescents by increasing protective factors and reducing risk through a family-based brief prevention intervention started in the pediatric emergency department (PED).
The primary aims of the proposed developmental study include: (1) To pilot test a prevention intervention in alcohol-naïve adolescents, make necessary revisions, and finalize an intervention manual and (2) conduct a randomized pilot trial comparing the prevention intervention with enhanced standard care.
After conducting an open trial of the prevention intervention with 10 adolescents, ages 12-14, and their accompanying parent(s), and refining the intervention, we will use a two-group randomized design to test the hypothesis that the prevention intervention will prevent/delay the initiation of alcohol use significantly more than enhanced standard care only.
100 adolescents, ages 12-14, who present to the PED and their accompanying parent(s)/caregiver will be enrolled into the study.
Eligible, assenting adolescents and their consenting parent(s)/caregiver will complete a series of assessment instruments relating to alcohol and other drug (AOD) use, communication styles, parenting styles, and alcohol attitudes and behaviors.
Parent/youth family units will then be randomly assigned to one of two conditions: 1) Enhanced Standard Care (ESC) or 2) Brief Targeted Prevention Intervention with Boosters (BTP).
The initial session will be comprised of parent-targeted skill building directed primarily at parental monitoring and the importance of parent-adolescent communication as the precursor to successful monitoring.
The primary goal of the prevention session will be the mobilization of the parents' own resources to increase communication and monitoring using motivational interviewing techniques.
Parents within this condition will also receive periodic brochures and telephone booster sessions at 1 and 3 months to explore parental implementation of the plan from the previous session(s) and make revisions as necessary.
Adolescents and parents will then be reassessed six months following their PED visit.
Adolescents will also be assessed with monthly, brief, web-based follow-up contacts to determine the status of their alcohol use.
Study Type
Interventional
Enrollment (Actual)
196
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
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Hasbro Children's Hospital Emergency Department
-
-
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
10 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adolescents, age 12-14, who are being seen in the Pediatric ED for a non life-threatening injury and their parent/caregiver;
- Adolescent must be medically stable;
- For a parent/adolescent family unit to be eligible, one or both of the adolescent's parents must be present in the ED with the adolescent; and
- The adolescent must report not having initiated alcohol use.
Exclusion Criteria:
- Family units in which either the parent or the adolescent are cognitively unable to take part in the intervention;
- Those in which the youth is suspected by the clinical staff of being a victim of child abuse (these adolescents will be reported to child protective services);
- Those in which the youth is medically or surgically unstable;
- Family units in which the adolescent is being evaluated for a possible psychiatric disorder; and those without a telephone and/or a verifiable address of residence.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Enhanced Standard Care (ESC)
Standard emergency department care plus informational brochures
|
Enhanced standard care
|
Experimental: Brief Prevention Intervention (BPI)
Brief Prevention Intervention in the Pediatric ED
|
Brief Prevention Intervention: Participants will receive the BPI, a brief, family-focused prevention intervention in the Pediatric ED.
The session will be comprised of parent-targeted skill building directed primarily at parental monitoring and the importance of parent-adolescent communication as the precursor to successful monitoring.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parental monitoring
Time Frame: 2 years
|
A one-tailed, α = 0.05 level of significance will be used to tests the difference between the BPI and ESC groups on hypotheses 2A on parental monitoring (using the PMQ and Parent/student self-check), 2B using the PMPI, drug use promoting peers, and parent/child beliefs and peers, 2C using scales on parent attitudes and parent beliefs about drug use, and 2D using intentions to use scale from the CTC.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James G Linakis, PhD, MD, University Emergency Medicine Foundation
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
July 1, 2010
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
April 15, 2010
First Submitted That Met QC Criteria
April 15, 2010
First Posted (Estimate)
April 16, 2010
Study Record Updates
Last Update Posted (Estimate)
November 5, 2014
Last Update Submitted That Met QC Criteria
November 3, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0088-08
- R21AA018380 (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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