NCT00095303

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2004

Longer than P75 for phase_3

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2004

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

July 7, 2015

Completed
Last Updated

July 7, 2015

Status Verified

June 1, 2015

Enrollment Period

3.4 years

First QC Date

November 2, 2004

Results QC Date

May 17, 2014

Last Update Submit

June 10, 2015

Conditions

Substance Abuse

Keywords

BSFTFamily TherapyAdolescentsSubstance Abuse

Outcome Measures

Primary Outcomes (16)

  • 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.

    Number of self reported drug use days from 28 days prior to baseline

  • Main Study, Adolescent Drug Use

    Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

    Number of self reported drug use days from day 1-28

  • Main Study, Adolescent Drug Use

    Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

    Number of self reported drug use days in days 29-56

  • Main Study, Adolescent Drug Use

    Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

    Number of self reported drug use days from day 57-84

  • Main Study, Adolescent Drug Use

    Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

    Number of self reported drug use days from day 85-112

  • Main Study, Adolescent Drug Use

    Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

    Number of self reported drug use days from day 113-140

  • Main Study, Adolescent Drug Use

    Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

    Number of self reported drug use days from day 141 - 168

  • Main Study, Adolescent Drug Use

    Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

    Number of self reported drug use days from day 169-196

  • Main Study, Adolescent Drug Use

    Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

    Number of self reported drug use days from day 197-224

  • Main Study, Adolescent Drug Use

    Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

    Number of self reported drug use days from day 225-252

  • Main Study, Adolescent Drug Use

    Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

    Number of self reported drug use days from day 253-280

  • Main Study, Adolescent Drug Use

    Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

    Number of self reported drug use from days 281-308

  • Main Study, Adolescent Drug Use

    Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

    Number of self reported drug use days from day 309-336

  • Main Study, Adolescent Drug Use

    Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.

    Number of self reported drug use days from day 337-364

  • 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.

    Number of self reported drug use days 90 days prior assessment

  • 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.

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

Secondary Outcomes (15)

  • Main Study, Externalizing Behaviors at Baseline

    Baseline

  • Main Study, Externalizing Behavior at 4 Months Post Randomization

    4 months post randomization

  • Main Study, Externalizing Behavior at 8 Months Post Randomization

    8 months post randomization

  • Main Study, Externalizing Behavior at 12 Months Post Randomization

    12 months post randomization

  • Follow Up Study, Externalizing Behavior

    90 days prior to assessment

  • +10 more secondary outcomes

Study Arms (2)

Brief Strategic Family Therapy (BSFT)

EXPERIMENTAL

BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period during the Main Study, and up to 8 "booster" sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school).

Behavioral: Brief Strategic Family Therapy (BSFT)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

Behavioral: Treatment as Usual

Interventions

Brief Strategic Family Therapy (BSFT)BEHAVIORAL

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).

Also known as: BSFT
Brief Strategic Family Therapy (BSFT)
Treatment as UsualBEHAVIORAL

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.

Also known as: TAU
Treatment as Usual (TAU)

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • suicidal or homicidal ideation.
  • Follow Up Study:
  • youth must have signed consent during the main study to be approached for future research
  • currently 18 years old or older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

La Frontera Center

Tucson, Arizona, 85713, United States

Location

Tarzana Treatment Center

Tarzana, California, 91356, United States

Location

Arapahoe House

Thornton, Colorado, 80260, United States

Location

Gateway Community Services

Jacksonville, Florida, 32224, United States

Location

The Villiage

Miami, Florida, 33137, United States

Location

Daymark

Concord, North Carolina, 28025, United States

Location

The Crossroads Center

Cincinnati, Ohio, 45219, United States

Location

Centro de Salud Mental de la Comunidad de Bayamsn

Bayamón, 00960, Puerto Rico

Location

Related Publications (8)

  • Horigian VE, Robbins MS, Dominguez R, Ucha J, Rosa CL. Principles for defining adverse events in behavioral intervention research: lessons from a family-focused adolescent drug abuse trial. Clin Trials. 2010 Feb;7(1):58-68. doi: 10.1177/1740774509356575.

    PMID: 20156957BACKGROUND

  • Robbins MS, Alonso E, Horigian VE, Bachrach K, Burlew K, Carrion IS, Hodgkins CC, Miller M, Schindler E, VanDeMark N, Henderson C, Szapocznik J. Transporting clinical research to community settings: designing and conducting a multisite trial of brief strategic family therapy. Addict Sci Clin Pract. 2010 Dec;5(2):54-61.

    PMID: 22002455BACKGROUND

  • Robbins MS, Feaster DJ, Horigian VE, Puccinelli MJ, Henderson C, Szapocznik J. Therapist adherence in brief strategic family therapy for adolescent drug abusers. J Consult Clin Psychol. 2011 Feb;79(1):43-53. doi: 10.1037/a0022146.

    PMID: 21261433BACKGROUND

  • Robbins MS, Feaster DJ, Horigian VE, Rohrbaugh M, Shoham V, Bachrach K, Miller M, Burlew KA, Hodgkins C, Carrion I, Vandermark N, Schindler E, Werstlein R, Szapocznik J. Brief strategic family therapy versus treatment as usual: results of a multisite randomized trial for substance using adolescents. J Consult Clin Psychol. 2011 Dec;79(6):713-27. doi: 10.1037/a0025477. Epub 2011 Oct 3.

    PMID: 21967492RESULT

  • Weems CF, Feaster DJ, Horigian VE, Robbins MS. Parent and child agreement on anxiety disorder symptoms using the DISC predictive scales. Assessment. 2011 Jun;18(2):213-6. doi: 10.1177/1073191110389278. Epub 2010 Nov 12.

    PMID: 21075957RESULT

  • Robbins MS, Szapocznik J, Horigian VE, Feaster DJ, Puccinelli M, Jacobs P, Burlew K, Werstlein R, Bachrach K, Brigham G. Brief strategic family therapy for adolescent drug abusers: a multi-site effectiveness study. Contemp Clin Trials. 2009 May;30(3):269-78. doi: 10.1016/j.cct.2009.01.004. Epub 2009 Jan 18.

    PMID: 19470315RESULT

  • Horigian VE, Feaster DJ, Brincks A, Robbins MS, Perez MA, Szapocznik J. The effects of Brief Strategic Family Therapy (BSFT) on parent substance use and the association between parent and adolescent substance use. Addict Behav. 2015 Mar;42:44-50. doi: 10.1016/j.addbeh.2014.10.024. Epub 2014 Nov 4.

    PMID: 25462653DERIVED

  • Horigian VE, Weems CF, Robbins MS, Feaster DJ, Ucha J, Miller M, Werstlein R. Reductions in anxiety and depression symptoms in youth receiving substance use treatment. Am J Addict. 2013 Jul-Aug;22(4):329-37. doi: 10.1111/j.1521-0391.2013.12031.x.

    PMID: 23795871DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Limitations and Caveats

Main Study: Low rates self-reported drug use leading to only examination of prevention of relapse/escalation of drug use Follow Up Study: Variability between the time of participation in main and follow up, so no direct casuality could be concluded

Results Point of Contact

Title
Viviana E. Horigian, MD
Organization
University of Miami Miller School of Medicine
vhorigian@med.miami.edu
305-243-4305

Study Officials

  • Jose Szapocznik, Ph.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Department of Epidemiology and Public Health

Study Record Dates

First Submitted

November 2, 2004

First Posted

November 3, 2004

Study Start

August 1, 2004

Primary Completion

January 1, 2008

Study Completion

August 1, 2011

Last Updated

July 7, 2015

Results First Posted

July 7, 2015

Record last verified: 2015-06

Locations

US(7)PR(1)