Emergency Department (ED) Adolescent Alcohol Prevention Intervention
Primary Purpose
Alcohol Drinking
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Prevention Intervention (BPI)
ESC
Sponsored by

About this trial
This is an interventional prevention trial for Alcohol Drinking focused on measuring Pediatric Emergency Department, Parental monitoring, Adolescent, Parents, Communication, Alcohol Drinking
Eligibility Criteria
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.
Sites / Locations
- Hasbro Children's Hospital Emergency Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Enhanced Standard Care (ESC)
Brief Prevention Intervention (BPI)
Arm Description
Standard emergency department care plus informational brochures
Brief Prevention Intervention in the Pediatric ED
Outcomes
Primary Outcome Measures
Parental monitoring
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01105416
First Posted
April 15, 2010
Last Updated
November 3, 2014
Sponsor
Rhode Island Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT01105416
Brief Title
Emergency Department (ED) Adolescent Alcohol Prevention Intervention
Official Title
Emergency Department Based Prevention Intervention to Delay Alcohol Use by Young Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
Keywords
Pediatric Emergency Department, Parental monitoring, Adolescent, Parents, Communication, Alcohol Drinking
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced Standard Care (ESC)
Arm Type
Placebo Comparator
Arm Description
Standard emergency department care plus informational brochures
Arm Title
Brief Prevention Intervention (BPI)
Arm Type
Experimental
Arm Description
Brief Prevention Intervention in the Pediatric ED
Intervention Type
Behavioral
Intervention Name(s)
Brief Prevention Intervention (BPI)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ESC
Intervention Description
Enhanced standard care
Primary Outcome Measure Information:
Title
Parental monitoring
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James G Linakis, PhD, MD
Organizational Affiliation
University Emergency Medicine Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasbro Children's Hospital Emergency Department
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Emergency Department (ED) Adolescent Alcohol Prevention Intervention
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