Family Intervention for Teen Drinking in the ER
This study is currently recruiting participants.
Verified May 2013 by University of Miami
Sponsor:
University of Miami
Information provided by (Responsible Party):
Cynthia Rowe, University of Miami
ClinicalTrials.gov Identifier:
NCT01229748
First received: October 26, 2010
Last updated: May 14, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | December 2014 |
| Estimated Primary Completion Date: | August 2014 (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:
- Between ages 12 to 18 years old
- Present in ER/trauma unit
- 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
- Not receiving any other behavioral treatment
- At least one parent/guardian is willing to participate in assessments and intervention
- Parent consent/youth assent
Exclusion Criteria:
- Meet DSM-IV dependence criteria for any substance other than alcohol, marijuana, or tobacco
- Mental retardation or pervasive developmental disorders
- Psychotic symptoms
- Current suicidality
Contacts and Locations
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 | |
| 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 | |
| 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 | |
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: | May 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013