Clinical trial NCT01229748: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2010-10-28
Enrollment: 104
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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?

Eligibility 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

Primary outcomes:
measure: Treatment engagement/retention
timeFrame: Proportion of adolescents enrolled in substance abuse treatment at 3 months post -intake.
Secondary outcomes:
measure: Alcohol use/abstinence
timeFrame: 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.
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Miami
country: United States
facility: Miami Children's Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Cynthia L Rowe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.