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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00484367
Other study ID # NIAAA-STA12178
Secondary ID R01AA012178NIH G
Status Active, not recruiting
Phase Phase 2/Phase 3
First received June 7, 2007
Last updated August 25, 2011
Start date July 1999
Est. completion date August 2012

Study information

Verified date November 2008
Source The Morton Center, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of two psychosocially-based, manual-driven, behavioral modalities. One of these is a standardized version of the established modality of Adolescent Group Therapy (AGT), which includes both psychoeducational and therapeutic components. The other is a state-of-the-art family therapy approach, Transitional Family Therapy (TFT), which integrates management of the current problem with exploration of multigenerational issues. Both approaches have been developed to expressly target adolescent alcohol problems.


Description:

Despite well-founded societal concerns over the use of illicit drugs by youth, alcohol use has persisted for decades as the number one adolescent substance abuse problem in the U.S. Further, research has shown that the earlier the onset of alcohol use, the more likely is a person to develop alcohol dependence later, during adulthood. Consequently, the need is clear for interventions which will arrest this process at the earliest point possible. Hence, interventions that mobilize a youth's social systems to help that young person deal with the problem, i.e., the family and peer systems, would make sense from a number of standpoints. Two primary modalities developed to deal with such issues are those examined here: family therapy and group therapy.

The participants were males and females, ages 13-17 at intake, with a DSM-IV diagnosis of either alcohol abuse or alcohol dependence. Following random assignment to condition, basic treatment in both conditions was based on a 12-session model and took approximately 3-4 months, followed by 1-2 aftercare sessions over an additional 1-2 months. The treatment was provided by therapists who were already working within the community (as opposed, for instance, to graduate students). Follow-up assessments were obtained at 3 months post-treatment, 1 year post-treatment, and 2 years post-treatment, thus allowing determination of the extent to which treatment effects "held up" to a degree not attained by most of the previous outcome studies within this domain.

Comparisons: AGT and TFT are being compared on the extent to which their participants used alcohol, as well as other substances, during the three post-treatment periods. Other comparisons include school performance (grade point average), family relations/functioning, and involvement with the legal system.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 13 Years to 17 Years
Eligibility Inclusion Criteria:

- Male and female outpatients 13-17 years of age at intake.

- Participants had a current DSM-IV diagnosis of either alcohol abuse or alcohol dependence.

- Participants signed a witnessed informed consent.

- Parent or custodian of each (adolescent) participant signed a witnessed informed consent.

Exclusion Criteria:

- Participants who met current DSM-IV criteria for bipolar disorder, psychotic disorder, or eating disorder.

- Enrollment in a residential substance abuse treatment program within 2 months prior to intake.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Adolescent group therapy
Adolescent group therapy
Transitional family therapy
Transitional family therapy

Locations

Country Name City State
United States The Morton Center Louisville Kentucky

Sponsors (2)

Lead Sponsor Collaborator
The Morton Center, Inc. National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Alcohol use Cannabis use Other substance use Baseline, 3 months post-treatment, 1 year post-treatment, and 2 years post-treatment No
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