Brief Strategic Family Therapy for Adolescent Drug Abusers (BSFT)

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Oregon Research Institute
Information provided by (Responsible Party):
Jose Szapocznik, University of Miami
ClinicalTrials.gov Identifier:
NCT00095303
First received: November 2, 2004
Last updated: June 10, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention Phase
Substance Abuse
Behavioral: Brief Strategic Family Therapy (BSFT)
Behavioral: Treatment as Usual
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Brief Strategic Family Therapy for Adolescent Drug Abusers

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Main Study, Adolescent Drug Use [ Time Frame: Number of self reported drug use days from 28 days prior to baseline ] [ Designated as safety issue: No ]
    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.

  • Main Study, Adolescent Drug Use [ Time Frame: Number of self reported drug use days from day 1-28 ] [ Designated as safety issue: No ]
    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.

  • Main Study, Adolescent Drug Use [ Time Frame: Number of self reported drug use days in days 29-56 ] [ Designated as safety issue: No ]
    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.

  • Main Study, Adolescent Drug Use [ Time Frame: Number of self reported drug use days from day 57-84 ] [ Designated as safety issue: No ]
    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.

  • Main Study, Adolescent Drug Use [ Time Frame: Number of self reported drug use days from day 85-112 ] [ Designated as safety issue: No ]
    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.

  • Main Study, Adolescent Drug Use [ Time Frame: Number of self reported drug use days from day 113-140 ] [ Designated as safety issue: No ]
    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.

  • Main Study, Adolescent Drug Use [ Time Frame: Number of self reported drug use days from day 141 - 168 ] [ Designated as safety issue: No ]
    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.

  • Main Study, Adolescent Drug Use [ Time Frame: Number of self reported drug use days from day 169-196 ] [ Designated as safety issue: No ]
    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.

  • Main Study, Adolescent Drug Use [ Time Frame: Number of self reported drug use days from day 197-224 ] [ Designated as safety issue: No ]
    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.

  • Main Study, Adolescent Drug Use [ Time Frame: Number of self reported drug use days from day 225-252 ] [ Designated as safety issue: No ]
    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.

  • Main Study, Adolescent Drug Use [ Time Frame: Number of self reported drug use days from day 253-280 ] [ Designated as safety issue: No ]
    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.

  • Main Study, Adolescent Drug Use [ Time Frame: Number of self reported drug use from days 281-308 ] [ Designated as safety issue: No ]
    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.

  • Main Study, Adolescent Drug Use [ Time Frame: Number of self reported drug use days from day 309-336 ] [ Designated as safety issue: No ]
    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.

  • Main Study, Adolescent Drug Use [ Time Frame: Number of self reported drug use days from day 337-364 ] [ Designated as safety issue: No ]
    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 assessment ] [ Designated as safety issue: No ]
    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.

  • Follow Up Study, Drug Use [ Time Frame: Number of self reported drug use days 90 days prior to assessment ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Main Study, Externalizing Behaviors at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: 'Total Delinquency' from the National Youth Survey; 'Oppositional Defiant Disorder' and 'Conduct Problems' from the Diagnostic Interview Schedule for Children-Predictive Scales, 'Externalizing Scale' from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.0. The higher the score, the more externalizing behavior.

  • Main Study, Externalizing Behavior at 4 Months Post Randomization [ Time Frame: 4 months post randomization ] [ Designated as safety issue: No ]
    For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: 'Total Delinquency' from the National Youth Survey; 'Oppositional Defiant Disorder' and 'Conduct Problems' from the Diagnostic Interview Schedule for Children-Predictive Scales, 'Externalizing Scale' from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.8. The higher the score, the more externalizing behavior.

  • Main Study, Externalizing Behavior at 8 Months Post Randomization [ Time Frame: 8 months post randomization ] [ Designated as safety issue: No ]
    For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: 'Total Delinquency' from the National Youth Survey; 'Oppositional Defiant Disorder' and 'Conduct Problems' from the Diagnostic Interview Schedule for Children-Predictive Scales, 'Externalizing Scale' from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.5. The higher the score, the more externalizing behavior.

  • Main Study, Externalizing Behavior at 12 Months Post Randomization [ Time Frame: 12 months post randomization ] [ Designated as safety issue: No ]
    For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: 'Total Delinquency' from the National Youth Survey; 'Oppositional Defiant Disorder' and 'Conduct Problems' from the Diagnostic Interview Schedule for Children-Predictive Scales, 'Externalizing Scale' from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.4. The higher the score, the more externalizing behavior.

  • Follow Up Study, Externalizing Behavior [ Time Frame: 90 days prior to assessment ] [ Designated as safety issue: No ]
    For the follow up study, externalizing behavior for the 90 days prior to the follow up was assessed using the externalizing composite of the Adult Self Report (ASR). The ASR is a 123 item self report scale designed for 18 to 59 year-old to describe their own functioning. Items are on a 3 point likert type scale (0= not true, 1=somewhat true, 2=very true or often true). The externalizing scale is comprised by the aggressive, rule braking and intrusive syndromes. The problem syndromes have been normed by sex and age (18 to 35, or 36 to 59), using a nationally representative sample. Scores were square-root transformed to more closely approximate a normal distribution. Scores ranged from 0 to 7.2. The higher the score, the more externalizing behavior. Participants were also asked to self report arrests in the past year . Externalizing was analyzed using regression

  • Main Study, Level of Family Functioning at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The four components of the 'Parenting Practices Inventory' used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline. Scores ranged from -3.0 to 1.8. The higher the score, the better outcome of family functioning.

  • Main Study, Level of Family Functioning at 4 Months Post Randomization [ Time Frame: 4 months post randomization ] [ Designated as safety issue: No ]
    The four components of the 'Parenting Practices Inventory' used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline. Scores ranged from -2.9 to 1.8. The higher the score, the better outcome of family functioning.

  • Main Study, Level of Family Functioning at 8 Months Post Randomization [ Time Frame: 8 months post randomization ] [ Designated as safety issue: Yes ]
    The four components of the 'Parenting Practices Inventory' used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline.Scores ranged from -2.8 to 2.0. The higher the score, the better outcome of family functioning.

  • Main Study, Level of Family Functioning at 12 Months Post Randomization [ Time Frame: 12 months post randomization ] [ Designated as safety issue: No ]
    The four components of the 'Parenting Practices Inventory' used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline.Scores ranged from -2.6 to 2.0. The higher the score, the better outcome of family functioning.

  • Follow Up Study, Level of Family Functioning [ Time Frame: 90 days prior assessment ] [ Designated as safety issue: No ]
    For the follow up study, family functioning was measured by a composite of the Cohesion and Conflict scales of the Family Environment Scale. Scores ranged from 1.0 to 18.0. The higher the value, the better the level of family functioning outcome.

  • Main Study, Risky Sexual Behaviors at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    For the Main Study, the total score of the 'HIV/Sex Risk Behaviors' measure was used as the outcome. Scores ranged from -0.5 to 8.7. The higher the score, the more risky sexual behavior.

  • Main Study, Risky Sexual Behaviors at 4 Months Post Randomization [ Time Frame: 4 months post randomization ] [ Designated as safety issue: No ]
    For the Main Study, the total score of the 'HIV/Sex Risk Behaviors' measure was used as the outcome. Scores ranged from -0.5 to 10.4. The higher the score, the more risky sexual behavior.

  • Main Study, Risky Sexual Behaviors at 8 Months Post Randomization [ Time Frame: 8 months post randomization ] [ Designated as safety issue: No ]
    For the Main Study, the total score of the 'HIV/Sex Risk Behaviors' measure was used as the outcome. Scores ranged from -0.5 to 6.8. The higher the score, the more risky sexual behavior.

  • Main Study, Risky Sexual Behaviors at 12 Months Post Randomization [ Time Frame: 12 months post randomization ] [ Designated as safety issue: No ]
    For the Main Study, the total score of the 'HIV/Sex Risk Behaviors' measure was used as the outcome. Scores ranged from -0.5 to 6.7. The higher the score, the more risky sexual behavior.

  • Follow Up Study, Risky Sexual Behaviors [ Time Frame: 90 days prior assessment ] [ Designated as safety issue: No ]
    For the Follow Up Study, sexual risk behavior was measured by examining the number of unprotected sexual acts and the number of partners and number of sex acts that included substance use the in the 90 day period that preceded the assessment; a latent factor using structural equation modeling will be used created from the Behavioral Risk Assessment. Scores ranged from -0.5 to 11.7. The higher the score, the more risky sexual behavior.


Enrollment: 480
Study Start Date: August 2004
Study Completion Date: August 2011
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brief Strategic Family Therapy (BSFT)
BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period during the Main Study, and up to 8 "booster" sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school).
Behavioral: Brief Strategic Family Therapy (BSFT)
BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period during the Main Study, and up to 8 "booster" sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school).
Other Name: BSFT
Active Comparator: Treatment as Usual (TAU)
TAU varies depending on site, however each will offer services that include at least 1 therapy session (individual or group therapy) per week during the Main Study, as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
Behavioral: Treatment as Usual
TAU varies depending on site, however each will offer services that include at least 1 therapy session (individual or group therapy) per week during the Main Study, as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
Other Name: TAU

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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Study:

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095303

Locations
United States, Arizona
La Frontera Center
Tucson, Arizona, United States, 85713
United States, California
Tarzana Treatment Center
Tarzana, California, United States, 91356
United States, Colorado
Arapahoe House
Thornton, Colorado, United States, 80260
United States, Florida
Gateway Community Services
Jacksonville, Florida, United States, 32224
The Villiage
Miami, Florida, United States, 33137
United States, North Carolina
Daymark
Concord, North Carolina, United States, 28025
United States, Ohio
The Crossroads Center
Cincinnati, Ohio, United States, 45219
Puerto Rico
Centro de Salud Mental de la Comunidad de Bayamsn
Bayamon, Puerto Rico, 00960
Sponsors and Collaborators
University of Miami
National Institute on Drug Abuse (NIDA)
Oregon Research Institute
Investigators
Principal Investigator: Jose Szapocznik, Ph.D. University of Miami
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jose Szapocznik, Chair, Department of Epidemiology and Public Health, University of Miami
ClinicalTrials.gov Identifier: NCT00095303     History of Changes
Other Study ID Numbers: 20090698  U10DA013720  5RC2DA028864 
Study First Received: November 2, 2004
Results First Received: May 17, 2014
Last Updated: June 10, 2015
Health Authority: United States: Federal Government

Keywords provided by University of Miami:
BSFT
Family Therapy
Adolescents
Substance Abuse

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 25, 2016