- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00095303
Brief Strategic Family Therapy for Adolescent Drug Abusers (BSFT)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Bayamon, Puerto Rico, 00960
- Centro de Salud Mental de la Comunidad de Bayamsn
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Arizona
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Tucson, Arizona, United States, 85713
- La Frontera Center
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California
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Tarzana, California, United States, 91356
- Tarzana Treatment Center
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Colorado
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Thornton, Colorado, United States, 80260
- Arapahoe House
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Florida
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Jacksonville, Florida, United States, 32224
- Gateway Community Services
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Miami, Florida, United States, 33137
- The Villiage
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North Carolina
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Concord, North Carolina, United States, 28025
- Daymark
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Ohio
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Cincinnati, Ohio, United States, 45219
- The Crossroads Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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).
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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 Names:
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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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Main Study, Adolescent Drug Use
Time Frame: Number of self reported drug use days from 28 days prior to baseline
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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.
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Number of self reported drug use days from 28 days prior to baseline
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Main Study, Adolescent Drug Use
Time Frame: Number of self reported drug use days from day 1-28
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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.
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Number of self reported drug use days from day 1-28
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Main Study, Adolescent Drug Use
Time Frame: Number of self reported drug use days in days 29-56
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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.
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Number of self reported drug use days in days 29-56
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Main Study, Adolescent Drug Use
Time Frame: Number of self reported drug use days from day 57-84
|
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.
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Number of self reported drug use days from day 57-84
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Main Study, Adolescent Drug Use
Time Frame: Number of self reported drug use days from day 85-112
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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.
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Number of self reported drug use days from day 85-112
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Main Study, Adolescent Drug Use
Time Frame: Number of self reported drug use days from day 113-140
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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.
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Number of self reported drug use days from day 113-140
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Main Study, Adolescent Drug Use
Time Frame: Number of self reported drug use days from day 141 - 168
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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.
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Number of self reported drug use days from day 141 - 168
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Main Study, Adolescent Drug Use
Time Frame: Number of self reported drug use days from day 169-196
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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.
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Number of self reported drug use days from day 169-196
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Main Study, Adolescent Drug Use
Time Frame: Number of self reported drug use days from day 197-224
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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.
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Number of self reported drug use days from day 197-224
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Main Study, Adolescent Drug Use
Time Frame: Number of self reported drug use days from day 225-252
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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.
|
Number of self reported drug use days from day 225-252
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Main Study, Adolescent Drug Use
Time Frame: Number of self reported drug use days from day 253-280
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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.
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Number of self reported drug use days from day 253-280
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Main Study, Adolescent Drug Use
Time Frame: Number of self reported drug use from days 281-308
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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.
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Number of self reported drug use from days 281-308
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Main Study, Adolescent Drug Use
Time Frame: Number of self reported drug use days from day 309-336
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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.
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Number of self reported drug use days from day 309-336
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Main Study, Adolescent Drug Use
Time Frame: Number of self reported drug use days from day 337-364
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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.
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Number of self reported drug use days from day 337-364
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Follow Up Study, Drug Use
Time Frame: Number of self reported drug use days 90 days prior assessment
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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.
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Number of self reported drug use days 90 days prior assessment
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Follow Up Study, Drug Use
Time Frame: Number of self reported drug use days 90 days prior to assessment
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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.
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Number of self reported drug use days 90 days prior to assessment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Main Study, Externalizing Behaviors at Baseline
Time Frame: Baseline
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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.
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Baseline
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Main Study, Externalizing Behavior at 4 Months Post Randomization
Time Frame: 4 months post randomization
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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.
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4 months post randomization
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Main Study, Externalizing Behavior at 8 Months Post Randomization
Time Frame: 8 months post randomization
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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.
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8 months post randomization
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Main Study, Externalizing Behavior at 12 Months Post Randomization
Time Frame: 12 months post randomization
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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.
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12 months post randomization
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Follow Up Study, Externalizing Behavior
Time Frame: 90 days prior to assessment
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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
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90 days prior to assessment
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Main Study, Level of Family Functioning at Baseline
Time Frame: Baseline
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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.
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Baseline
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Main Study, Level of Family Functioning at 4 Months Post Randomization
Time Frame: 4 months post randomization
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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.
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4 months post randomization
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Main Study, Level of Family Functioning at 8 Months Post Randomization
Time Frame: 8 months post randomization
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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.
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8 months post randomization
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Main Study, Level of Family Functioning at 12 Months Post Randomization
Time Frame: 12 months post randomization
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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.
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12 months post randomization
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Follow Up Study, Level of Family Functioning
Time Frame: 90 days prior assessment
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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.
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90 days prior assessment
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Main Study, Risky Sexual Behaviors at Baseline
Time Frame: Baseline
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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.
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Baseline
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Main Study, Risky Sexual Behaviors at 4 Months Post Randomization
Time Frame: 4 months post randomization
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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.
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4 months post randomization
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Main Study, Risky Sexual Behaviors at 8 Months Post Randomization
Time Frame: 8 months post randomization
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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.
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8 months post randomization
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Main Study, Risky Sexual Behaviors at 12 Months Post Randomization
Time Frame: 12 months post randomization
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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.
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12 months post randomization
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Follow Up Study, Risky Sexual Behaviors
Time Frame: 90 days prior assessment
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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.
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90 days prior assessment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jose Szapocznik, Ph.D., University of Miami
Publications and helpful links
General Publications
- Horigian VE, Robbins MS, Dominguez R, Ucha J, Rosa CL. Principles for defining adverse events in behavioral intervention research: lessons from a family-focused adolescent drug abuse trial. Clin Trials. 2010 Feb;7(1):58-68. doi: 10.1177/1740774509356575.
- Robbins MS, Alonso E, Horigian VE, Bachrach K, Burlew K, Carrion IS, Hodgkins CC, Miller M, Schindler E, VanDeMark N, Henderson C, Szapocznik J. Transporting clinical research to community settings: designing and conducting a multisite trial of brief strategic family therapy. Addict Sci Clin Pract. 2010 Dec;5(2):54-61.
- Robbins MS, Feaster DJ, Horigian VE, Puccinelli MJ, Henderson C, Szapocznik J. Therapist adherence in brief strategic family therapy for adolescent drug abusers. J Consult Clin Psychol. 2011 Feb;79(1):43-53. doi: 10.1037/a0022146.
- Robbins MS, Feaster DJ, Horigian VE, Rohrbaugh M, Shoham V, Bachrach K, Miller M, Burlew KA, Hodgkins C, Carrion I, Vandermark N, Schindler E, Werstlein R, Szapocznik J. Brief strategic family therapy versus treatment as usual: results of a multisite randomized trial for substance using adolescents. J Consult Clin Psychol. 2011 Dec;79(6):713-27. doi: 10.1037/a0025477. Epub 2011 Oct 3.
- Weems CF, Feaster DJ, Horigian VE, Robbins MS. Parent and child agreement on anxiety disorder symptoms using the DISC predictive scales. Assessment. 2011 Jun;18(2):213-6. doi: 10.1177/1073191110389278. Epub 2010 Nov 12.
- Robbins MS, Szapocznik J, Horigian VE, Feaster DJ, Puccinelli M, Jacobs P, Burlew K, Werstlein R, Bachrach K, Brigham G. Brief strategic family therapy for adolescent drug abusers: a multi-site effectiveness study. Contemp Clin Trials. 2009 May;30(3):269-78. doi: 10.1016/j.cct.2009.01.004. Epub 2009 Jan 18.
- Horigian VE, Feaster DJ, Brincks A, Robbins MS, Perez MA, Szapocznik J. The effects of Brief Strategic Family Therapy (BSFT) on parent substance use and the association between parent and adolescent substance use. Addict Behav. 2015 Mar;42:44-50. doi: 10.1016/j.addbeh.2014.10.024. Epub 2014 Nov 4.
- Horigian VE, Weems CF, Robbins MS, Feaster DJ, Ucha J, Miller M, Werstlein R. Reductions in anxiety and depression symptoms in youth receiving substance use treatment. Am J Addict. 2013 Jul-Aug;22(4):329-37. doi: 10.1111/j.1521-0391.2013.12031.x.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20090698
- U10DA013720 (U.S. NIH Grant/Contract)
- 5RC2DA028864 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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