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Family Intervention for Teen Drinking in the ER

Primary Purpose

Alcohol Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Care
Multidimensional Family Therapy
Family Motivational Interviewing Intervention
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jackson Memorial Hospital
  • University of Miami Miller School of Medicine
  • Miami Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Multidimensional Family Therapy

Family Motivational Interviewing

Standard Care

Arm Description

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).

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).

The standard care condition will represent typical services for teens with alcohol problems in the community: assessment and referral for treatment

Outcomes

Primary Outcome Measures

Treatment engagement/retention
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
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.

Full Information

First Posted
October 26, 2010
Last Updated
April 29, 2015
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT01229748
Brief Title
Family Intervention for Teen Drinking in the ER
Official Title
Family Intervention for Teen Drinking and Alcohol-Related Crises in the ER
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Aim 1: To investigate in a randomized controlled trial the engagement potential and effectiveness of family-centered intervention (MDFT) and family-involved MI (FMII) for teens with alcohol problems Hypothesis 1a: Treatment engagement will be higher in MDFT and FMII than in standard care as evidenced by higher numbers of MDFT and FMII youth enrolled in substance abuse treatment. Hypothesis 1b: Treatment completion will be higher for MDFT than FMII/group and standard care as evidenced by more teens/families in MDFT completing a full course of treatment. Hypothesis 1c: Youth assigned to MDFT and FMII/group will show greater decreases in alcohol use and binge drinking than youth in standard care at the 3 month follow-up (end of treatment). 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. Hypothesis 1d: Youth assigned to MDFT and FMII/group will show greater reductions than youth in standard care in problems related to alcohol use, including drug use, drinking and driving, alcohol-related injury, health and mental health problems, school problems, delinquency, and association with substance abusing peers at the 3 month follow-up (end of treatment). Youth in MDFT will show greater reductions in these problems than FMII/group and standard care in the post-treatment period and up to 18 month follow-up. Aim 2: To explore differential treatment effects with comorbid adolescents Hypothesis 2: For youth with low baseline levels of alcohol, drug, and psychiatric problems, MDFT and FMII/group will both be more effective than standard care. MDFT will reduce alcohol use more significantly than FMII/group for teens with more severe baseline alcohol, drug, and psychiatric problems. Aim 3: To examine the contribution of motivation and family factors as mediators of treatment effects Hypothesis 3a: In both MDFT and FMII/group, motivation to change at the end of the initial engagement sessions in both teen and parent will predict treatment participation and 3 month outcomes (end of treatment) to a greater extent than motivation in the teen or parent alone. Hypothesis 3b: In both MDFT and FMII/group, effective parenting practices and strong family relationships will predict better alcohol and related outcomes at 3 month follow-up. Aim 4: To examine long-term abstinence, patterns and predictors of relapse up to 18 months follow-up Hypothesis 4a: Four distinct patterns of relapse will emerge between 3 month and 18 month follow-up: high abstinence, low abstinence, decreasing abstinence, and increasing abstinence. Hypothesis 4b: MDFT youth will be more likely to be in the high abstinence and increasing abstinence groups; youth in FMII/group will be more likely to be in the decreasing abstinence group; and youth in standard care will be more likely to be in the low abstinence group. Hypothesis 4c: Youth in MDFT will show more significant reductions in risk factors for alcohol relapse (family dysfunction, lack of abstinence motivation, positive alcohol expectancies, poor abstinence coping, lack of support for abstinence) than youth in FMII/group or standard care. Aim 5: To compare the total/net monetary benefits to society of MDFT, FMII/group, and standard care Hypothesis 5: MDFT and FMII/group will generate significantly higher total and net monetary benefits to society than youth in standard care at 18 months post-ER visit. Research Question 5: Will MDFT or FMII/group generate higher total/net benefits to society?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multidimensional Family Therapy
Arm Type
Experimental
Arm Description
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).
Arm Title
Family Motivational Interviewing
Arm Type
Experimental
Arm Description
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).
Arm Title
Standard Care
Arm Type
Other
Arm Description
The standard care condition will represent typical services for teens with alcohol problems in the community: assessment and referral for treatment
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
Clients attend two 90-minute group sessions per week.Treatment lasts for three months.
Intervention Type
Behavioral
Intervention Name(s)
Multidimensional Family Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Family Motivational Interviewing Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment engagement/retention
Description
To investigate the engagement potential and effectiveness of a family-centered intervention (MDFT) and family-involved MI (FMII) for teens with alcohol-related crises.
Time Frame
Proportion of adolescents enrolled in substance abuse treatment at 3 months post -intake.
Secondary Outcome Measure Information:
Title
Alcohol use/abstinence
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia L Rowe, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16639858
Citation
Rowe CL, Liddle HA. Family-based treatment development for adolescent alcohol abuse. Int J Adolesc Med Health. 2006 Jan-Mar;18(1):43-51. doi: 10.1515/ijamh.2006.18.1.43.
Results Reference
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Family Intervention for Teen Drinking in the ER

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