NCT01229748

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2010

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 1, 2015

Status Verified

April 1, 2015

Enrollment Period

4.4 years

First QC Date

October 26, 2010

Last Update Submit

April 29, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Proportion of adolescents enrolled in substance abuse treatment at 3 months post -intake.

Secondary Outcomes (1)

  • Alcohol use/abstinence

    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.

Study Arms (3)

Multidimensional Family Therapy

EXPERIMENTAL

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

Family Motivational Interviewing

EXPERIMENTAL

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

Standard Care

OTHER

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

Behavioral: Standard Care

Interventions

Standard CareBEHAVIORAL

Clients attend two 90-minute group sessions per week.Treatment lasts for three months.

Standard Care

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.

Multidimensional Family Therapy

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.

Family Motivational Interviewing

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Meet DSM-IV dependence criteria for any substance other than alcohol, marijuana, or tobacco
  • Mental retardation or pervasive developmental disorders
  • Psychotic symptoms
  • Current suicidality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

Related Publications (1)

  • 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.

    PMID: 16639858BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Cynthia L Rowe, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 26, 2010

First Posted

October 28, 2010

Study Start

November 1, 2010

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

May 1, 2015

Record last verified: 2015-04

Locations