Emergency Department (ED) Adolescent Alcohol Prevention Intervention

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Rhode Island Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01105416
First received: April 15, 2010
Last updated: August 3, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention
Alcohol Drinking
Behavioral: Brief Prevention Intervention (BPI)
Behavioral: ESC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Emergency Department Based Prevention Intervention to Delay Alcohol Use by Young Adolescents

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Parental monitoring [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 220
Study Start Date: July 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Enhanced Standard Care (ESC)
Standard emergency department care plus informational brochures
Behavioral: ESC
Enhanced standard care
Experimental: Brief Prevention Intervention (BPI)
Brief Prevention Intervention in the Pediatric ED
Behavioral: Brief Prevention Intervention (BPI)
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.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adolescents, age 12-14, who are being seen in the Pediatric ED for a non life-threatening injury and their parent/caregiver;
  2. Adolescent must be medically stable;
  3. 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
  4. The adolescent must report not having initiated alcohol use.

Exclusion Criteria:

  1. Family units in which either the parent or the adolescent are cognitively unable to take part in the intervention;
  2. 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);
  3. Those in which the youth is medically or surgically unstable;
  4. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105416

Contacts
Contact: James G Linakis, PhD, MD 401-444-6680 James_Linakis@brown.edu

Locations
United States, Rhode Island
Hasbro Children's Hospital Emergency Department Recruiting
Providence, Rhode Island, United States, 02903
Contact: James G Linakis, PhD, MD    401-444-6680    James_Linakis@brown.edu   
Principal Investigator: James G Linakis, PhD, MD         
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: James G Linakis, PhD, MD University Emergency Medicine Foundation
  More Information

No publications provided

Responsible Party: James G. Linakis, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01105416     History of Changes
Other Study ID Numbers: 0088-08, R21AA018380
Study First Received: April 15, 2010
Last Updated: August 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
Pediatric Emergency Department
Parental monitoring
Adolescent
Parents
Communication
Alcohol Drinking

Additional relevant MeSH terms:
Alcohol Drinking
Emergencies
Drinking Behavior
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014