NCT01105416

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 16, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

1.6 years

First QC Date

April 15, 2010

Last Update Submit

November 3, 2014

Conditions

Alcohol Drinking

Keywords

Pediatric Emergency DepartmentParental monitoringAdolescentParentsCommunicationAlcohol Drinking

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Study Arms (2)

Enhanced Standard Care (ESC)

PLACEBO COMPARATOR

Standard emergency department care plus informational brochures

Behavioral: ESC

Brief Prevention Intervention (BPI)

EXPERIMENTAL

Brief Prevention Intervention in the Pediatric ED

Behavioral: Brief Prevention Intervention (BPI)

Interventions

Brief Prevention Intervention (BPI)BEHAVIORAL

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.

Brief Prevention Intervention (BPI)
ESCBEHAVIORAL

Enhanced standard care

Enhanced Standard Care (ESC)

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasbro Children's Hospital Emergency Department

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Alcohol DrinkingCommunication

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • James G Linakis, PhD, MD

    University Emergency Medicine Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 15, 2010

First Posted

April 16, 2010

Study Start

July 1, 2010

Primary Completion

February 1, 2012

Study Completion

June 1, 2012

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

US(1)