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Family Intervention for Teen Drinking in the ER

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by University of Miami
Sponsor:
Information provided by (Responsible Party):
Cynthia Rowe, University of Miami
ClinicalTrials.gov Identifier:
NCT01229748
First received: October 26, 2010
Last updated: November 20, 2014
Last verified: November 2014
  Purpose

The investigators propose a randomized controlled trial with five aims: 1. To investigate the engagement potential and effectiveness of a family-centered intervention (MDFT) and Family Motivational Interviewing Intervention (FMII)/group for teens with alcohol-related crises; 2. To explore differential treatment effects with comorbid adolescents; 3. To examine the role of motivation and family factors as treatment mediators; 4. To examine long-term abstinence, patterns and predictors of relapse up to 18 months follow-up; and 5. To compare the total and net monetary benefits to society of MDFT, FMII/group, and standard care.


Condition Intervention
Alcohol Abuse
Behavioral: Standard Care
Behavioral: Multidimensional Family Therapy
Behavioral: Family Motivational Interviewing Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Family Intervention for Teen Drinking and Alcohol-Related Crises in the ER

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Treatment engagement/retention [ Time Frame: Proportion of adolescents enrolled in substance abuse treatment at 3 months post -intake. ] [ Designated as safety issue: No ]
    To investigate the engagement potential and effectiveness of a family-centered intervention (MDFT) and family-involved MI (FMII) for teens with alcohol-related crises.


Secondary Outcome Measures:
  • Alcohol use/abstinence [ Time Frame: Youth assigned to MDFT and FMII/group will show greater decreases in alcohol use and binge drinking than youth in standard care at 3 months post intake. ] [ Designated as safety issue: No ]
    MDFT participants will show greater decreases in alcohol use and binge drinking than FMII/group and standard care during the post-treatment period and up to 18 month follow-up, and they will be less likely to meet diagnostic criteria for an AUD at 18 months.


Estimated Enrollment: 150
Study Start Date: November 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multidimensional Family Therapy
Multidimensional Family Therapy is an outpatient family-based treatment for troubled youth.(Liddle, 2002) considered in the U.S. and abroad as an empirically supported Best Practice treatment for teen substance abuse and delinquency (USDHHS 2002; Drug Strategies 2003; NIDA 1999; Rigter et al 2004).
Behavioral: Multidimensional Family Therapy
Multidimensional Family Therapy is an outpatient family-based treatment for troubled youth (Liddle, 2002). Treatment duration is 3 months, sessions last 60-90 minutes, with an average of 2 sessions per week and additional extrafamilial work and phone contacts as needed.
Experimental: Family Motivational Interviewing
Motivational Interviewing (MI; Miller 1983; Miller & Rollnick 1991), is a client-centered treatment designed to strengthen clients' commitment and empower them to change their substance use behavior (Miller & Rollnick 2002).
Behavioral: Family Motivational Interviewing Intervention
Youth and parents receive 2 FMII sessions in their homes within 72 hours of the ER incident, and youth will be linked with group treatment lasting 3 months.
Standard Care
The standard care condition will represent typical services for teens with alcohol problems in the community: assessment and referral for treatment
Behavioral: Standard Care
Clients attend two 90-minute group sessions per week.Treatment lasts for three months.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Between ages 12 to 18 years old
  2. Present in ER/trauma unit
  3. Meet minimum cut-off of 4 on the AUDIT; OR BAC of 0.01% or more on QED; OR report alcohol use within 6 hours of ER visit
  4. Not receiving any other behavioral treatment
  5. At least one parent/guardian is willing to participate in assessments and intervention
  6. Parent consent/youth assent

Exclusion Criteria:

  1. Meet DSM-IV dependence criteria for any substance other than alcohol, marijuana, or tobacco
  2. Mental retardation or pervasive developmental disorders
  3. Psychotic symptoms
  4. Current suicidality
  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: NCT01229748

Contacts
Contact: Linda R Alberga, MS 305-243-3325 lalberga@med.miami.edu

Locations
United States, Florida
Jackson Memorial Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Hector Chavez, MD    305-585-7050    hchavez@jhsmiami.org   
Miami Children's Hospital Completed
Miami, Florida, United States, 33155
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Linda R Alberga, MS    305-243-3325    lalberga@med.miami.edu   
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Cynthia L Rowe, PhD University of Miami
  More Information

Publications:
Responsible Party: Cynthia Rowe, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01229748     History of Changes
Other Study ID Numbers: 20090623
Study First Received: October 26, 2010
Last Updated: November 20, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 23, 2014