Substance Abuse
Conditions
Keywords
BSFT, Family Therapy, Adolescents, Substance Abuse
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.
Interventions
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).
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.
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Main Study, Adolescent Drug Use | Number of self reported drug use days from 28 days prior to baseline | 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 | Number of self reported drug use days 90 days prior 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
| Measure | Time frame | Description |
|---|---|---|
| Main Study, Externalizing Behavior at 8 Months Post Randomization | 8 months post randomization | 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 | 12 months post randomization | 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 | 90 days prior to assessment | 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 | Baseline | 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 | 4 months post randomization | 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 | 8 months post randomization | 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, Externalizing Behaviors at Baseline | Baseline | 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. |
| Follow Up Study, Level of Family Functioning | 90 days prior assessment | 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 | Baseline | 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 | 4 months post randomization | 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 | 8 months post randomization | 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 | 12 months post randomization | 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 | 90 days prior assessment | 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. |
| Main Study, Level of Family Functioning at 12 Months Post Randomization | 12 months post randomization | 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. |
| Main Study, Externalizing Behavior at 4 Months Post Randomization | 4 months post randomization | 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. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Main Study: Adolescents who self-reported illicit drug use in the 30-days before baseline assessment or had to be referred from an institution for the treatment of drug abuse. Extended Follow Up Study: Participants from the Main Study who agreed to be contacted in the future, regardless of Main completion, were recruited to complete the assessment.
Participants by arm
| Arm | Count |
|---|---|
| BSFT BSFT: Brief Strategic Family Therapy. 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members | 245 |
| TAU- Treatment as Usual TAU: Treatment As Usual. Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management | 235 |
| Total | 480 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow Up Study | Lost to Follow-up | 59 | 58 |
| Main Study | Lost to Follow-up | 91 | 87 |
Baseline characteristics
| Characteristic | BSFT | Total | TAU- Treatment as Usual |
|---|---|---|---|
| Age, Categorical <=18 years | 0 participants in follow up study | 0 participants in follow up study | 0 participants in follow up study |
| Age, Categorical >=65 years | 0 participants in follow up study | 0 participants in follow up study | 0 participants in follow up study |
| Age, Categorical Between 18 and 65 years | 140 participants in follow up study | 261 participants in follow up study | 121 participants in follow up study |
| Age, Categorical <=18 years | 245 Participants | 480 Participants | 235 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 62 participants in follow up study | 115 participants in follow up study | 53 participants in follow up study |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 78 participants in follow up study | 146 participants in follow up study | 68 participants in follow up study |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 participants in follow up study | 0 participants in follow up study | 0 participants in follow up study |
| Ethnicity (NIH/OMB) Hispanic or Latino | 107 Participants | 213 Participants | 106 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 133 Participants | 258 Participants | 125 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 9 Participants | 4 Participants |
| Gender Female | 26 participants in follow up study | 53 participants in follow up study | 27 participants in follow up study |
| Gender Male | 114 participants in follow up study | 208 participants in follow up study | 94 participants in follow up study |
| Sex: Female, Male Female | 50 Participants | 103 Participants | 53 Participants |
| Sex: Female, Male Male | 195 Participants | 377 Participants | 182 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 144 / 245 | 133 / 235 |
| serious Total, serious adverse events | 16 / 245 | 16 / 235 |
Outcome results
Follow Up Study, Drug Use
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.
Time frame: Number of self reported drug use days 90 days prior assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BSFT | Follow Up Study, Drug Use | 19.5 days of drug use 90 days prior assessmen |
| TAU- Treatment as Usual | Follow Up Study, Drug Use | 25 days of drug use 90 days prior assessmen |
Follow Up Study, Drug Use
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.
Time frame: Number of self reported drug use days 90 days prior to assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BSFT | Follow Up Study, Drug Use | 8 days of drug use 90 days prior assessmen |
| TAU- Treatment as Usual | Follow Up Study, Drug Use | 10 days of drug use 90 days prior assessmen |
Main Study, Adolescent Drug Use
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.
Time frame: Number of self reported drug use days in days 29-56
Population: The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 29-56. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BSFT | Main Study, Adolescent Drug Use | 2 days of drug use in days 29-56 |
| TAU- Treatment as Usual | Main Study, Adolescent Drug Use | 1 days of drug use in days 29-56 |
Main Study, Adolescent Drug Use
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.
Time frame: Number of self reported drug use days from 28 days prior to baseline
Population: The number of participants analyzed represents the number of participants that completed the baseline time point, assessing for the past 28 days. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BSFT | Main Study, Adolescent Drug Use | 3 days of drug use 28 days prior baseline |
| TAU- Treatment as Usual | Main Study, Adolescent Drug Use | 3 days of drug use 28 days prior baseline |
Main Study, Adolescent Drug Use
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.
Time frame: Number of self reported drug use days from day 1-28
Population: The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 1-28. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BSFT | Main Study, Adolescent Drug Use | 1 days of drug use from day 1-28 |
| TAU- Treatment as Usual | Main Study, Adolescent Drug Use | 2 days of drug use from day 1-28 |
Main Study, Adolescent Drug Use
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.
Time frame: Number of self reported drug use days from day 57-84
Population: The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 57-84. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BSFT | Main Study, Adolescent Drug Use | 1 days of drug use from day 57-84 |
| TAU- Treatment as Usual | Main Study, Adolescent Drug Use | 1 days of drug use from day 57-84 |
Main Study, Adolescent Drug Use
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.
Time frame: Number of self reported drug use days from day 85-112
Population: The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 85-112. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BSFT | Main Study, Adolescent Drug Use | 1 days of drug use from day 85-112 |
| TAU- Treatment as Usual | Main Study, Adolescent Drug Use | 2 days of drug use from day 85-112 |
Main Study, Adolescent Drug Use
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.
Time frame: Number of self reported drug use days from day 113-140
Population: The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 113-140. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BSFT | Main Study, Adolescent Drug Use | 1 days of drug use from days 113-140 |
| TAU- Treatment as Usual | Main Study, Adolescent Drug Use | 1 days of drug use from days 113-140 |
Main Study, Adolescent Drug Use
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.
Time frame: Number of self reported drug use days from day 141 - 168
Population: The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 141-168. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BSFT | Main Study, Adolescent Drug Use | 1 days of drug use from day 141-168 |
| TAU- Treatment as Usual | Main Study, Adolescent Drug Use | 1.5 days of drug use from day 141-168 |
Main Study, Adolescent Drug Use
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.
Time frame: Number of self reported drug use days from day 169-196
Population: The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 169-196. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BSFT | Main Study, Adolescent Drug Use | 1 days of drug use from day 169-196 |
| TAU- Treatment as Usual | Main Study, Adolescent Drug Use | 1 days of drug use from day 169-196 |
Main Study, Adolescent Drug Use
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.
Time frame: Number of self reported drug use days from day 197-224
Population: The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 197-224. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BSFT | Main Study, Adolescent Drug Use | 1 days of drug use from day 197-224 |
| TAU- Treatment as Usual | Main Study, Adolescent Drug Use | 1 days of drug use from day 197-224 |
Main Study, Adolescent Drug Use
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.
Time frame: Number of self reported drug use days from day 225-252
Population: The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 225-252. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BSFT | Main Study, Adolescent Drug Use | 2 days of drug use from day 225-252 |
| TAU- Treatment as Usual | Main Study, Adolescent Drug Use | 2 days of drug use from day 225-252 |
Main Study, Adolescent Drug Use
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.
Time frame: Number of self reported drug use days from day 253-280
Population: The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 253-280. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BSFT | Main Study, Adolescent Drug Use | 2 days of drug use from day 253-280 |
| TAU- Treatment as Usual | Main Study, Adolescent Drug Use | 2 days of drug use from day 253-280 |
Main Study, Adolescent Drug Use
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.
Time frame: Number of self reported drug use from days 281-308
Population: The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 281-308. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BSFT | Main Study, Adolescent Drug Use | 2 days of drug use from day 281-308 |
| TAU- Treatment as Usual | Main Study, Adolescent Drug Use | 2 days of drug use from day 281-308 |
Main Study, Adolescent Drug Use
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.
Time frame: Number of self reported drug use days from day 309-336
Population: The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 309-336. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BSFT | Main Study, Adolescent Drug Use | 2 days of drug use from day 309-336 |
| TAU- Treatment as Usual | Main Study, Adolescent Drug Use | 3 days of drug use from day 309-336 |
Main Study, Adolescent Drug Use
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.
Time frame: Number of self reported drug use days from day 337-364
Population: The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 337-364. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BSFT | Main Study, Adolescent Drug Use | 2 days of drug use from day 337-364 |
| TAU- Treatment as Usual | Main Study, Adolescent Drug Use | 3.5 days of drug use from day 337-364 |
Follow Up Study, Externalizing Behavior
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
Time frame: 90 days prior to assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BSFT | Follow Up Study, Externalizing Behavior | 3.1 units on a scale | Standard Deviation 1.5 |
| TAU- Treatment as Usual | Follow Up Study, Externalizing Behavior | 3.5 units on a scale | Standard Deviation 1.5 |
Follow Up Study, Level of Family Functioning
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.
Time frame: 90 days prior assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BSFT | Follow Up Study, Level of Family Functioning | 13.2 units on a scale | Standard Deviation 4.2 |
| TAU- Treatment as Usual | Follow Up Study, Level of Family Functioning | 12.4 units on a scale | Standard Deviation 4 |
Follow Up Study, Risky Sexual Behaviors
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.
Time frame: 90 days prior assessment
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BSFT | Follow Up Study, Risky Sexual Behaviors | 2.06 units on a scale | Standard Error 0.06 |
| TAU- Treatment as Usual | Follow Up Study, Risky Sexual Behaviors | 2.20 units on a scale | Standard Error 0.1 |
Main Study, Externalizing Behavior at 12 Months Post Randomization
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.
Time frame: 12 months post randomization
Population: The number of participants analyzed represents the number of participants that completed this time point, assessing for externalizing behavior at 12 months post randomization. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BSFT | Main Study, Externalizing Behavior at 12 Months Post Randomization | -.45 units on a scale | Standard Deviation 0.93 |
| TAU- Treatment as Usual | Main Study, Externalizing Behavior at 12 Months Post Randomization | -.52 units on a scale | Standard Deviation 0.87 |
Main Study, Externalizing Behavior at 4 Months Post Randomization
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.
Time frame: 4 months post randomization
Population: The number of participants analyzed represents the number of participants that completed this time point, assessing for externalizing behavior at 4 months post randomization. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BSFT | Main Study, Externalizing Behavior at 4 Months Post Randomization | -.36 units on a scale | Standard Deviation 0.89 |
| TAU- Treatment as Usual | Main Study, Externalizing Behavior at 4 Months Post Randomization | -.21 units on a scale | Standard Deviation 1.07 |
Main Study, Externalizing Behavior at 8 Months Post Randomization
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.
Time frame: 8 months post randomization
Population: The number of participants analyzed represents the number of participants that completed this time point, assessing for externalizing behavior at 8 months post randomization. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BSFT | Main Study, Externalizing Behavior at 8 Months Post Randomization | -.45 units on a scale | Standard Deviation 0.81 |
| TAU- Treatment as Usual | Main Study, Externalizing Behavior at 8 Months Post Randomization | -.39 units on a scale | Standard Deviation 0.99 |
Main Study, Externalizing Behaviors at Baseline
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.
Time frame: Baseline
Population: The number of participants analyzed represents the number of participants that completed this time point, assessing externalizing behaviors at baseline. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BSFT | Main Study, Externalizing Behaviors at Baseline | -.004 units on a scale | Standard Deviation 1.01 |
| TAU- Treatment as Usual | Main Study, Externalizing Behaviors at Baseline | .004 units on a scale | Standard Deviation 1.03 |
Main Study, Level of Family Functioning at 12 Months Post Randomization
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.
Time frame: 12 months post randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BSFT | Main Study, Level of Family Functioning at 12 Months Post Randomization | 0.35 units on a scale | Standard Deviation 0.96 |
| TAU- Treatment as Usual | Main Study, Level of Family Functioning at 12 Months Post Randomization | 0.14 units on a scale | Standard Deviation 0.99 |
Main Study, Level of Family Functioning at 4 Months Post Randomization
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.
Time frame: 4 months post randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BSFT | Main Study, Level of Family Functioning at 4 Months Post Randomization | 0.15 units on a scale | Standard Deviation 1.02 |
| TAU- Treatment as Usual | Main Study, Level of Family Functioning at 4 Months Post Randomization | 0.21 units on a scale | Standard Deviation 0.94 |
Main Study, Level of Family Functioning at 8 Months Post Randomization
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.
Time frame: 8 months post randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BSFT | Main Study, Level of Family Functioning at 8 Months Post Randomization | 0.31 units on a scale | Standard Deviation 0.96 |
| TAU- Treatment as Usual | Main Study, Level of Family Functioning at 8 Months Post Randomization | 0.25 units on a scale | Standard Deviation 0.97 |
Main Study, Level of Family Functioning at Baseline
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BSFT | Main Study, Level of Family Functioning at Baseline | -0.03 units on a scale | Standard Error 1.01 |
| TAU- Treatment as Usual | Main Study, Level of Family Functioning at Baseline | 0.04 units on a scale | Standard Error 0.99 |
Main Study, Risky Sexual Behaviors at 12 Months Post Randomization
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.
Time frame: 12 months post randomization
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BSFT | Main Study, Risky Sexual Behaviors at 12 Months Post Randomization | 1.30 units on a scale | Standard Error 0.14 |
| TAU- Treatment as Usual | Main Study, Risky Sexual Behaviors at 12 Months Post Randomization | 1.44 units on a scale | Standard Error 0.12 |
Main Study, Risky Sexual Behaviors at 4 Months Post Randomization
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.
Time frame: 4 months post randomization
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BSFT | Main Study, Risky Sexual Behaviors at 4 Months Post Randomization | .89 units on a scale | Standard Error 0.12 |
| TAU- Treatment as Usual | Main Study, Risky Sexual Behaviors at 4 Months Post Randomization | 1.18 units on a scale | Standard Error 0.12 |
Main Study, Risky Sexual Behaviors at 8 Months Post Randomization
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.
Time frame: 8 months post randomization
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BSFT | Main Study, Risky Sexual Behaviors at 8 Months Post Randomization | 1.01 units on a scale | Standard Error 0.12 |
| TAU- Treatment as Usual | Main Study, Risky Sexual Behaviors at 8 Months Post Randomization | 1.32 units on a scale | Standard Error 0.12 |
Main Study, Risky Sexual Behaviors at Baseline
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.
Time frame: Baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BSFT | Main Study, Risky Sexual Behaviors at Baseline | .95 units on a scale | Standard Error 0.14 |
| TAU- Treatment as Usual | Main Study, Risky Sexual Behaviors at Baseline | 1.00 units on a scale | Standard Error 0.12 |