Trial Outcomes & Findings for Brief Strategic Family Therapy for Adolescent Drug Abusers (NCT NCT00095303)

NCT ID: NCT00095303

Last Updated: 2015-07-07

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 480 participants
• Primary outcome timeframe: Number of self reported drug use days from 28 days prior to baseline
• Results posted on: 2015-07-07

Participant Flow

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.

Participant milestones

Measure	BSFT Brief Strategic Family Therapy For Adolescent Drug Abusers : 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, 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).	Treatment as Usual Treatment as Usual : TAU varies depending on site, however each will offer services that include at least 1 therapy session per week (individual or group therapy) as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
Main Study STARTED	245	235
Main Study COMPLETED	154	148
Main Study NOT COMPLETED	91	87
Follow Up Study STARTED	199	179
Follow Up Study COMPLETED	140	121
Follow Up Study NOT COMPLETED	59	58

Reasons for withdrawal

Measure	BSFT Brief Strategic Family Therapy For Adolescent Drug Abusers : 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, 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).	Treatment as Usual Treatment as Usual : TAU varies depending on site, however each will offer services that include at least 1 therapy session per week (individual or group therapy) as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
Main Study Lost to Follow-up	91	87
Follow Up Study Lost to Follow-up	59	58

Baseline Characteristics

Brief Strategic Family Therapy for Adolescent Drug Abusers

Baseline characteristics by cohort

Measure	BSFT n=245 Participants BSFT: Brief Strategic Family Therapy. 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members	TAU- Treatment as Usual n=235 Participants 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	Total n=480 Participants Total of all reporting groups
Age, Categorical <=18 years	0 participants in follow up study n=93 Participants	0 participants in follow up study n=4 Participants	0 participants in follow up study n=27 Participants
Age, Categorical Between 18 and 65 years	140 participants in follow up study n=93 Participants	121 participants in follow up study n=4 Participants	261 participants in follow up study n=27 Participants
Age, Categorical >=65 years	0 participants in follow up study n=93 Participants	0 participants in follow up study n=4 Participants	0 participants in follow up study n=27 Participants
Sex: Female, Male Female	50 Participants n=93 Participants	53 Participants n=4 Participants	103 Participants n=27 Participants
Sex: Female, Male Male	195 Participants n=93 Participants	182 Participants n=4 Participants	377 Participants n=27 Participants
Gender Female	26 participants in follow up study n=93 Participants	27 participants in follow up study n=4 Participants	53 participants in follow up study n=27 Participants
Gender Male	114 participants in follow up study n=93 Participants	94 participants in follow up study n=4 Participants	208 participants in follow up study n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	62 participants in follow up study n=93 Participants	53 participants in follow up study n=4 Participants	115 participants in follow up study n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	78 participants in follow up study n=93 Participants	68 participants in follow up study n=4 Participants	146 participants in follow up study n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 participants in follow up study n=93 Participants	0 participants in follow up study n=4 Participants	0 participants in follow up study n=27 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BSFT n=245 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=234 Participants TAU: Treat 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
Main Study, Adolescent Drug Use	3 days of drug use 28 days prior baseline Interval 1.0 to 11.0	3 days of drug use 28 days prior baseline Interval 0.0 to 9.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BSFT n=219 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=201 Participants TAU: Treat 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
Main Study, Adolescent Drug Use	1 days of drug use from day 1-28 Interval 0.0 to 6.0	2 days of drug use from day 1-28 Interval 0.0 to 8.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BSFT n=211 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=192 Participants TAU: Treat 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
Main Study, Adolescent Drug Use	2 days of drug use in days 29-56 Interval 0.0 to 7.0	1 days of drug use in days 29-56 Interval 0.0 to 8.5

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BSFT n=208 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=185 Participants TAU: Treat 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
Main Study, Adolescent Drug Use	1 days of drug use from day 57-84 Interval 0.0 to 6.5	1 days of drug use from day 57-84 Interval 0.0 to 7.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BSFT n=194 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=179 Participants TAU: Treat 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
Main Study, Adolescent Drug Use	1 days of drug use from day 85-112 Interval 0.0 to 7.0	2 days of drug use from day 85-112 Interval 0.0 to 7.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BSFT n=186 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=176 Participants TAU: Treat 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
Main Study, Adolescent Drug Use	1 days of drug use from days 113-140 Interval 0.0 to 6.0	1 days of drug use from days 113-140 Interval 0.0 to 6.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BSFT n=187 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=170 Participants TAU: Treat 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
Main Study, Adolescent Drug Use	1 days of drug use from day 141-168 Interval 0.0 to 8.0	1.5 days of drug use from day 141-168 Interval 0.0 to 8.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BSFT n=173 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=162 Participants TAU: Treat 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
Main Study, Adolescent Drug Use	1 days of drug use from day 169-196 Interval 0.0 to 7.0	1 days of drug use from day 169-196 Interval 0.0 to 9.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BSFT n=173 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=162 Participants TAU: Treat 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
Main Study, Adolescent Drug Use	1 days of drug use from day 197-224 Interval 0.0 to 10.0	1 days of drug use from day 197-224 Interval 0.0 to 8.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BSFT n=165 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=161 Participants TAU: Treat 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
Main Study, Adolescent Drug Use	2 days of drug use from day 225-252 Interval 0.0 to 9.0	2 days of drug use from day 225-252 Interval 0.0 to 8.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BSFT n=170 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=155 Participants TAU: Treat 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
Main Study, Adolescent Drug Use	2 days of drug use from day 253-280 Interval 0.0 to 8.0	2 days of drug use from day 253-280 Interval 0.0 to 8.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BSFT n=169 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=153 Participants TAU: Treat 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
Main Study, Adolescent Drug Use	2 days of drug use from day 281-308 Interval 0.0 to 10.0	2 days of drug use from day 281-308 Interval 0.0 to 10.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BSFT n=162 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=149 Participants TAU: Treat 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
Main Study, Adolescent Drug Use	2 days of drug use from day 309-336 Interval 0.0 to 10.0	3 days of drug use from day 309-336 Interval 0.0 to 10.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BSFT n=157 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=140 Participants TAU: Treat 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
Main Study, Adolescent Drug Use	2 days of drug use from day 337-364 Interval 0.0 to 9.0	3.5 days of drug use from day 337-364 Interval 0.0 to 11.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	BSFT n=140 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=121 Participants TAU: Treat 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
Follow Up Study, Drug Use	19.5 days of drug use 90 days prior assessmen Interval 5.0 to 81.0	25 days of drug use 90 days prior assessmen Interval 6.0 to 82.0

PRIMARY outcome

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

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

Outcome measures

Measure	BSFT n=140 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=121 Participants TAU: Treat 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
Follow Up Study, Drug Use	8 days of drug use 90 days prior assessmen Interval 2.0 to 28.0	10 days of drug use 90 days prior assessmen Interval 2.0 to 28.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BSFT n=245 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=235 Participants TAU: Treat 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
Main Study, Externalizing Behaviors at Baseline	-.004 units on a scale Standard Deviation 1.01	.004 units on a scale Standard Deviation 1.03

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BSFT n=191 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=185 Participants TAU: Treat 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
Main Study, Externalizing Behavior at 4 Months Post Randomization	-.36 units on a scale Standard Deviation .89	-.21 units on a scale Standard Deviation 1.07

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BSFT n=168 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=162 Participants TAU: Treat 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
Main Study, Externalizing Behavior at 8 Months Post Randomization	-.45 units on a scale Standard Deviation .81	-.39 units on a scale Standard Deviation .99

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BSFT n=164 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=153 Participants TAU: Treat 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
Main Study, Externalizing Behavior at 12 Months Post Randomization	-.45 units on a scale Standard Deviation .93	-.52 units on a scale Standard Deviation .87

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	BSFT n=140 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=121 Participants TAU: Treat 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
Follow Up Study, Externalizing Behavior	3.1 units on a scale Standard Deviation 1.5	3.5 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	BSFT n=245 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=235 Participants TAU: Treat 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
Main Study, Level of Family Functioning at Baseline	-0.03 units on a scale Standard Error 1.01	0.04 units on a scale Standard Error 0.99

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	BSFT n=194 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=188 Participants TAU: Treat 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
Main Study, Level of Family Functioning at 4 Months Post Randomization	0.15 units on a scale Standard Deviation 1.02	0.21 units on a scale Standard Deviation 0.94

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	BSFT n=169 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=164 Participants TAU: Treat 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
Main Study, Level of Family Functioning at 8 Months Post Randomization	0.31 units on a scale Standard Deviation 0.96	0.25 units on a scale Standard Deviation 0.97

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	BSFT n=169 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=158 Participants TAU: Treat 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
Main Study, Level of Family Functioning at 12 Months Post Randomization	0.35 units on a scale Standard Deviation 0.96	0.14 units on a scale Standard Deviation 0.99

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	BSFT n=141 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=121 Participants TAU: Treat 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
Follow Up Study, Level of Family Functioning	13.2 units on a scale Standard Deviation 4.2	12.4 units on a scale Standard Deviation 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	BSFT n=245 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=235 Participants TAU: Treat 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
Main Study, Risky Sexual Behaviors at Baseline	.95 units on a scale Standard Error .14	1.00 units on a scale Standard Error .12

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	BSFT n=191 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=185 Participants TAU: Treat 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
Main Study, Risky Sexual Behaviors at 4 Months Post Randomization	.89 units on a scale Standard Error .12	1.18 units on a scale Standard Error .12

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	BSFT n=168 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=163 Participants TAU: Treat 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
Main Study, Risky Sexual Behaviors at 8 Months Post Randomization	1.01 units on a scale Standard Error .12	1.32 units on a scale Standard Error .12

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	BSFT n=164 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=154 Participants TAU: Treat 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
Main Study, Risky Sexual Behaviors at 12 Months Post Randomization	1.30 units on a scale Standard Error .14	1.44 units on a scale Standard Error .12

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	BSFT n=140 Participants BSFT: * 12-16 sessions, ranging from 8 to 24 as full dose * Sessions include adolescents and family members	TAU- Treatment as Usual n=121 Participants TAU: Treat 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
Follow Up Study, Risky Sexual Behaviors	2.06 units on a scale Standard Error .06	2.20 units on a scale Standard Error .10

Adverse Events

BSFT

Serious events: 16 serious events

Other events: 144 other events

Deaths: 0 deaths

Treatment as Usual

Serious events: 16 serious events

Other events: 133 other events

Deaths: 0 deaths

Serious adverse events

Measure	BSFT n=245 participants at risk Brief Strategic Family Therapy For Adolescent Drug Abusers: 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, 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).	Treatment as Usual n=235 participants at risk Treatment as Usual: TAU varies depending on site, however each will offer services that include at least 1 therapy session per week (individual or group therapy) as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
Social circumstances Physical/ Sexual Abuse	0.82% 2/245 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.	0.85% 2/235 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.
Social circumstances Suicidal Behavior	3.3% 8/245 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.	2.1% 5/235 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.
Social circumstances Homicidal Behavior	1.2% 3/245 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.	1.7% 4/235 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.
Social circumstances Hospitalization	3.3% 8/245 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.	3.4% 8/235 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.
Social circumstances Death	0.00% 0/245 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.	0.43% 1/235 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.
Social circumstances Other Unexpected SAE	0.00% 0/245 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.	0.43% 1/235 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.

Other adverse events

Measure	BSFT n=245 participants at risk Brief Strategic Family Therapy For Adolescent Drug Abusers: 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, 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).	Treatment as Usual n=235 participants at risk Treatment as Usual: TAU varies depending on site, however each will offer services that include at least 1 therapy session per week (individual or group therapy) as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
Social circumstances Arrest	34.7% 85/245 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.	33.6% 79/235 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.
Social circumstances Runaway	13.9% 34/245 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.	19.1% 45/235 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.
Social circumstances Kicked out of home	2.4% 6/245 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.	1.7% 4/235 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.
Social circumstances School suspension	29.4% 72/245 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.	30.2% 71/235 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.
Social circumstances Violence	12.7% 31/245 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.	9.8% 23/235 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.
Social circumstances Other Unexpected Adverse Event	4.9% 12/245 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.	1.3% 3/235 • 12 months Main Study:Adverse Events (AE) tracked- arrest, school suspension/drop out, runaway, kicked out of home, violence. Serious Adverse Events (SAE) tracked-physical/sexual abuse, suicidal/homicidal behavior, hospitalization, death. Follow Up Study:AE/SAE's not tracked given brief time of involvement in the study/minimal risk in completing assessment.

Additional Information

Viviana E. Horigian, MD

University of Miami Miller School of Medicine

Phone: 305-243-4305

Email: vhorigian@med.miami.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place