Skip to content

Brief Strategic Family Therapy for Adolescent Drug Abusers

Brief Strategic Family Therapy for Adolescent Drug Abusers

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00095303
Acronym
BSFT
Enrollment
480
Registered
2004-11-03
Start date
2004-08-31
Completion date
2011-08-31
Last updated
2015-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Abuse

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

BEHAVIORALBrief 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).

BEHAVIORALTreatment as Usual

TAU varies depending on site, however each will offer services that include at least 1 therapy session (individual or group therapy) per week during the Main Study, as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Oregon Research Institute
CollaboratorOTHER
University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Main Study, Adolescent Drug UseNumber of self reported drug use days from 28 days prior to baselineTimeline 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 UseNumber of self reported drug use days 90 days prior assessmentTimeline 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

MeasureTime frameDescription
Main Study, Externalizing Behavior at 8 Months Post Randomization8 months post randomizationFor 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 Randomization12 months post randomizationFor 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 Behavior90 days prior to assessmentFor 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 BaselineBaselineThe 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 Randomization4 months post randomizationThe 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 Randomization8 months post randomizationThe 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 BaselineBaselineFor 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 Functioning90 days prior assessmentFor 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 BaselineBaselineFor 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 Randomization4 months post randomizationFor 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 Randomization8 months post randomizationFor 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 Randomization12 months post randomizationFor 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 Behaviors90 days prior assessmentFor 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 Randomization12 months post randomizationThe 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 Randomization4 months post randomizationFor 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

ArmCount
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
Total480

Withdrawals & dropouts

PeriodReasonFG000FG001
Follow Up StudyLost to Follow-up5958
Main StudyLost to Follow-up9187

Baseline characteristics

CharacteristicBSFTTotalTAU- Treatment as Usual
Age, Categorical
<=18 years
0 participants in follow up study0 participants in follow up study0 participants in follow up study
Age, Categorical
>=65 years
0 participants in follow up study0 participants in follow up study0 participants in follow up study
Age, Categorical
Between 18 and 65 years
140 participants in follow up study261 participants in follow up study121 participants in follow up study
Age, Categorical
<=18 years
245 Participants480 Participants235 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
62 participants in follow up study115 participants in follow up study53 participants in follow up study
Ethnicity (NIH/OMB)
Not Hispanic or Latino
78 participants in follow up study146 participants in follow up study68 participants in follow up study
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 participants in follow up study0 participants in follow up study0 participants in follow up study
Ethnicity (NIH/OMB)
Hispanic or Latino
107 Participants213 Participants106 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
133 Participants258 Participants125 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants9 Participants4 Participants
Gender
Female
26 participants in follow up study53 participants in follow up study27 participants in follow up study
Gender
Male
114 participants in follow up study208 participants in follow up study94 participants in follow up study
Sex: Female, Male
Female
50 Participants103 Participants53 Participants
Sex: Female, Male
Male
195 Participants377 Participants182 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
144 / 245133 / 235
serious
Total, serious adverse events
16 / 24516 / 235

Outcome results

Primary

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

ArmMeasureValue (MEDIAN)
BSFTFollow Up Study, Drug Use19.5 days of drug use 90 days prior assessmen
TAU- Treatment as UsualFollow Up Study, Drug Use25 days of drug use 90 days prior assessmen
Comparison: Null Hypothesis: BSFT will be significantly more effective than TAU in the rates of drug use, defined as the percentage of drug use days in last 90 days. The primary hypothesis will be evaluated in terms of % of days of drug use in the last 90 days, assessed by the timeline follow-back. The general analytic approach will use generalized estimating equation (GEE) with negative binomial distribution comparing the BSFT and TAU participantsp-value: 0.2195% CI: [0.82, 1.09]GEE
Primary

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

ArmMeasureValue (MEDIAN)
BSFTFollow Up Study, Drug Use8 days of drug use 90 days prior assessmen
TAU- Treatment as UsualFollow Up Study, Drug Use10 days of drug use 90 days prior assessmen
Primary

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.

ArmMeasureValue (MEDIAN)
BSFTMain Study, Adolescent Drug Use2 days of drug use in days 29-56
TAU- Treatment as UsualMain Study, Adolescent Drug Use1 days of drug use in days 29-56
Primary

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.

ArmMeasureValue (MEDIAN)
BSFTMain Study, Adolescent Drug Use3 days of drug use 28 days prior baseline
TAU- Treatment as UsualMain Study, Adolescent Drug Use3 days of drug use 28 days prior baseline
Comparison: Null Hypothesis: BSFT will be significantly more effective than TAU in reducing adolescent drug abuse, defined as the percentage of drug use days in 28-day periods. The outcome variable is the percentage of days of drug use within a 28-day period. This variable constructed from the Timeline-Follow-back instrument and measured as the sum of the number of days with positive use in 28-day increments. Hypothesis tested using hierarchical linear models.p-value: 0.2795% CI: [-0.04, 0.14]Mixed Models Analysis
Primary

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.

ArmMeasureValue (MEDIAN)
BSFTMain Study, Adolescent Drug Use1 days of drug use from day 1-28
TAU- Treatment as UsualMain Study, Adolescent Drug Use2 days of drug use from day 1-28
Primary

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.

ArmMeasureValue (MEDIAN)
BSFTMain Study, Adolescent Drug Use1 days of drug use from day 57-84
TAU- Treatment as UsualMain Study, Adolescent Drug Use1 days of drug use from day 57-84
Primary

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.

ArmMeasureValue (MEDIAN)
BSFTMain Study, Adolescent Drug Use1 days of drug use from day 85-112
TAU- Treatment as UsualMain Study, Adolescent Drug Use2 days of drug use from day 85-112
Primary

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.

ArmMeasureValue (MEDIAN)
BSFTMain Study, Adolescent Drug Use1 days of drug use from days 113-140
TAU- Treatment as UsualMain Study, Adolescent Drug Use1 days of drug use from days 113-140
Primary

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.

ArmMeasureValue (MEDIAN)
BSFTMain Study, Adolescent Drug Use1 days of drug use from day 141-168
TAU- Treatment as UsualMain Study, Adolescent Drug Use1.5 days of drug use from day 141-168
Primary

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.

ArmMeasureValue (MEDIAN)
BSFTMain Study, Adolescent Drug Use1 days of drug use from day 169-196
TAU- Treatment as UsualMain Study, Adolescent Drug Use1 days of drug use from day 169-196
Primary

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.

ArmMeasureValue (MEDIAN)
BSFTMain Study, Adolescent Drug Use1 days of drug use from day 197-224
TAU- Treatment as UsualMain Study, Adolescent Drug Use1 days of drug use from day 197-224
Primary

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.

ArmMeasureValue (MEDIAN)
BSFTMain Study, Adolescent Drug Use2 days of drug use from day 225-252
TAU- Treatment as UsualMain Study, Adolescent Drug Use2 days of drug use from day 225-252
Primary

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.

ArmMeasureValue (MEDIAN)
BSFTMain Study, Adolescent Drug Use2 days of drug use from day 253-280
TAU- Treatment as UsualMain Study, Adolescent Drug Use2 days of drug use from day 253-280
Primary

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.

ArmMeasureValue (MEDIAN)
BSFTMain Study, Adolescent Drug Use2 days of drug use from day 281-308
TAU- Treatment as UsualMain Study, Adolescent Drug Use2 days of drug use from day 281-308
Primary

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.

ArmMeasureValue (MEDIAN)
BSFTMain Study, Adolescent Drug Use2 days of drug use from day 309-336
TAU- Treatment as UsualMain Study, Adolescent Drug Use3 days of drug use from day 309-336
Primary

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.

ArmMeasureValue (MEDIAN)
BSFTMain Study, Adolescent Drug Use2 days of drug use from day 337-364
TAU- Treatment as UsualMain Study, Adolescent Drug Use3.5 days of drug use from day 337-364
Secondary

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

ArmMeasureValue (MEAN)Dispersion
BSFTFollow Up Study, Externalizing Behavior3.1 units on a scaleStandard Deviation 1.5
TAU- Treatment as UsualFollow Up Study, Externalizing Behavior3.5 units on a scaleStandard Deviation 1.5
Comparison: Null hypothesis: It is hypothesized that BSFT will be significantly more effective than TAU in the level of externalizing problem behaviorsp-value: <0.00695% CI: [-0.71, -0.12]GEE
Secondary

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

ArmMeasureValue (MEAN)Dispersion
BSFTFollow Up Study, Level of Family Functioning13.2 units on a scaleStandard Deviation 4.2
TAU- Treatment as UsualFollow Up Study, Level of Family Functioning12.4 units on a scaleStandard Deviation 4
p-value: 0.1295% CI: [-0.18, 1.54]GEE
Secondary

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

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
BSFTFollow Up Study, Risky Sexual Behaviors2.06 units on a scaleStandard Error 0.06
TAU- Treatment as UsualFollow Up Study, Risky Sexual Behaviors2.20 units on a scaleStandard Error 0.1
p-value: 0.2395% CI: [-0.09, 0.37]GEE
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
BSFTMain Study, Externalizing Behavior at 12 Months Post Randomization-.45 units on a scaleStandard Deviation 0.93
TAU- Treatment as UsualMain Study, Externalizing Behavior at 12 Months Post Randomization-.52 units on a scaleStandard Deviation 0.87
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
BSFTMain Study, Externalizing Behavior at 4 Months Post Randomization-.36 units on a scaleStandard Deviation 0.89
TAU- Treatment as UsualMain Study, Externalizing Behavior at 4 Months Post Randomization-.21 units on a scaleStandard Deviation 1.07
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
BSFTMain Study, Externalizing Behavior at 8 Months Post Randomization-.45 units on a scaleStandard Deviation 0.81
TAU- Treatment as UsualMain Study, Externalizing Behavior at 8 Months Post Randomization-.39 units on a scaleStandard Deviation 0.99
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
BSFTMain Study, Externalizing Behaviors at Baseline-.004 units on a scaleStandard Deviation 1.01
TAU- Treatment as UsualMain Study, Externalizing Behaviors at Baseline.004 units on a scaleStandard Deviation 1.03
Comparison: Null hypothesis: It is hypothesized that BSFT will be significantly more effective than TAU in decreasing adolescent externalizing problem behaviorsp-value: 0.2695% CI: [-0.28, 0.08]Mixed Models Analysis
Secondary

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

ArmMeasureValue (MEAN)Dispersion
BSFTMain Study, Level of Family Functioning at 12 Months Post Randomization0.35 units on a scaleStandard Deviation 0.96
TAU- Treatment as UsualMain Study, Level of Family Functioning at 12 Months Post Randomization0.14 units on a scaleStandard Deviation 0.99
Secondary

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

ArmMeasureValue (MEAN)Dispersion
BSFTMain Study, Level of Family Functioning at 4 Months Post Randomization0.15 units on a scaleStandard Deviation 1.02
TAU- Treatment as UsualMain Study, Level of Family Functioning at 4 Months Post Randomization0.21 units on a scaleStandard Deviation 0.94
Secondary

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

ArmMeasureValue (MEAN)Dispersion
BSFTMain Study, Level of Family Functioning at 8 Months Post Randomization0.31 units on a scaleStandard Deviation 0.96
TAU- Treatment as UsualMain Study, Level of Family Functioning at 8 Months Post Randomization0.25 units on a scaleStandard Deviation 0.97
Secondary

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

ArmMeasureValue (MEAN)Dispersion
BSFTMain Study, Level of Family Functioning at Baseline-0.03 units on a scaleStandard Error 1.01
TAU- Treatment as UsualMain Study, Level of Family Functioning at Baseline0.04 units on a scaleStandard Error 0.99
Comparison: Null hypothesis: BSFT will be significantly more effective than TAU in improving family functioning.The four components of the 'Parenting Practices Inventory' will be 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. Hypothesis will be analyzed as using hierarchical linear models.p-value: 0.01595% CI: [0.03, 0.22]Mixed Models Analysis
Secondary

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

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
BSFTMain Study, Risky Sexual Behaviors at 12 Months Post Randomization1.30 units on a scaleStandard Error 0.14
TAU- Treatment as UsualMain Study, Risky Sexual Behaviors at 12 Months Post Randomization1.44 units on a scaleStandard Error 0.12
Secondary

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

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
BSFTMain Study, Risky Sexual Behaviors at 4 Months Post Randomization.89 units on a scaleStandard Error 0.12
TAU- Treatment as UsualMain Study, Risky Sexual Behaviors at 4 Months Post Randomization1.18 units on a scaleStandard Error 0.12
Secondary

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

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
BSFTMain Study, Risky Sexual Behaviors at 8 Months Post Randomization1.01 units on a scaleStandard Error 0.12
TAU- Treatment as UsualMain Study, Risky Sexual Behaviors at 8 Months Post Randomization1.32 units on a scaleStandard Error 0.12
Secondary

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

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
BSFTMain Study, Risky Sexual Behaviors at Baseline.95 units on a scaleStandard Error 0.14
TAU- Treatment as UsualMain Study, Risky Sexual Behaviors at Baseline1.00 units on a scaleStandard Error 0.12
Comparison: Null hypothesis: BSFT will be significantly more effective than TAU in decreasing sexually risky behaviors. The total score of the 'HIV/Sex Risk Behaviors' measure will be used as the outcome.Hypothesis analyzed using the hierarchical linear model.p-value: 0.1295% CI: [-0.09, 0.76]GEE

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026