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Clinical Trials/NCT00095303
NCT00095303
Completed
Phase 3

Brief Strategic Family Therapy for Adolescent Drug Abusers

University of Miami8 sites in 2 countries480 target enrollmentAugust 2004
ConditionsSubstance Abuse

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Substance Abuse
Sponsor
University of Miami
Enrollment
480
Locations
8
Primary Endpoint
Main Study, Adolescent Drug Use
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to compare Brief Strategic Family Therapy (BSFT) for Adolescent Drug Abusers to treatment as usual (TAU).

An additional follow up assessment, funded by an American Recovery & Reinvestment Act (ARRA) grant, was completed 5 years post randomization in order to examine the long term effects of outpatient treatments for illicit drug using adolescents.

Detailed Description

Adolescent drug abuse continues to be one of the most pressing public health issues in the United States-our nation's teenagers continue to use illicit drugs at a worrisome rate. Broad reviews of the treatment outcome literature indicate that family interventions in general, and Brief Strategic Family Therapy (BSFT) in particular, are effective with drug using youth. This study is designed to compare BSFT to treatment as usual (TAU). The researchers believe that BSFT will be much more effective than TAU in reducing adolescent drug use. They will also examine which of these treatment approaches does a better job of engaging adolescents and family members in treatment, decreasing problem behaviors, decreasing sexually risky behaviors, increasing pro-social activities (e.g., school, work), and improving the functioning of the family. With the addition of the extended follow up, we have the opportunity to examine the sustainability of study outcomes into early adulthood, filling a gap in the treatment research literature about the long-term effects of adolescent substance abuse treatment. The follow up study examined the long term effectiveness of BSFT compared to TAU in the rates of substance use, number of arrests and externalizing behaviors, in youth who received study treatments at the time when they were adolescents.

Registry
clinicaltrials.gov
Start Date
August 2004
End Date
August 2011
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jose Szapocznik

Chair, Department of Epidemiology and Public Health

University of Miami

Eligibility Criteria

Inclusion Criteria

  • adolescents ages 12 to 17
  • used any illicit drugs (other than alcohol and tobacco) in the 30-day period
  • live with or intend to live with a formal or informal family

Exclusion Criteria

  • suicidal or homicidal ideation.
  • Follow Up Study:
  • Inclusion Criteria:
  • youth must have signed consent during the main study to be approached for future research
  • currently 18 years old or older

Outcomes

Primary Outcomes

Main Study, Adolescent Drug Use

Time Frame: Number of self reported drug use days from day 337-364

Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

Follow Up Study, Drug Use

Time Frame: Number of self reported drug use days 90 days prior to assessment

Timeline Follow Back (TLFB) measured drug use. For the Follow Up Study, the TLFB was used to identify drug use in the 90 day period that preceded the assessment. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use over the past 90 days. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use.The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 90 days.

Secondary Outcomes

  • Main Study, Level of Family Functioning at 4 Months Post Randomization(4 months post randomization)
  • Main Study, Level of Family Functioning at 8 Months Post Randomization(8 months post randomization)
  • Main Study, Level of Family Functioning at 12 Months Post Randomization(12 months post randomization)
  • Main Study, Externalizing Behaviors at Baseline(Baseline)
  • Main Study, Externalizing Behavior at 4 Months Post Randomization(4 months post randomization)
  • Main Study, Externalizing Behavior at 12 Months Post Randomization(12 months post randomization)
  • Follow Up Study, Risky Sexual Behaviors(90 days prior assessment)
  • Main Study, Externalizing Behavior at 8 Months Post Randomization(8 months post randomization)
  • Follow Up Study, Level of Family Functioning(90 days prior assessment)
  • Main Study, Risky Sexual Behaviors at Baseline(Baseline)
  • Main Study, Risky Sexual Behaviors at 12 Months Post Randomization(12 months post randomization)
  • Follow Up Study, Externalizing Behavior(90 days prior to assessment)
  • Main Study, Level of Family Functioning at Baseline(Baseline)
  • Main Study, Risky Sexual Behaviors at 4 Months Post Randomization(4 months post randomization)
  • Main Study, Risky Sexual Behaviors at 8 Months Post Randomization(8 months post randomization)

Study Sites (8)

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