Emergency Department (ED) Adolescent Alcohol Prevention Intervention
Recruitment status was Recruiting
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.
Behavioral: Brief Prevention Intervention (BPI)
|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|
- 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.
|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)|
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
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105416
|Contact: James G Linakis, PhD, MD||401-444-6680||James_Linakis@brown.edu|
|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|
|Principal Investigator:||James G Linakis, PhD, MD||University Emergency Medicine Foundation|