Clinical trial NCT00095303: Brief Strategic Family Therapy for Adolescent Drug Abusers
Official title: Brief Strategic Family Therapy for Adolescent Drug Abusers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Substance Abuse
Keywords: BSFT
Family Therapy
Adolescents
Substance Abuse
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Oregon Research Institute
First posted: 2004-11-03
Enrollment: 480
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Main Study, Adolescent Drug Use
timeFrame: Number of self reported drug use days from 28 days prior to baseline
measure: Main Study, Adolescent Drug Use
timeFrame: Number of self reported drug use days from day 1-28
measure: Main Study, Adolescent Drug Use
timeFrame: Number of self reported drug use days in days 29-56
measure: Main Study, Adolescent Drug Use
timeFrame: Number of self reported drug use days from day 57-84
measure: Main Study, Adolescent Drug Use
timeFrame: Number of self reported drug use days from day 85-112
measure: Main Study, Adolescent Drug Use
timeFrame: Number of self reported drug use days from day 113-140
measure: Main Study, Adolescent Drug Use
timeFrame: Number of self reported drug use days from day 141 - 168
measure: Main Study, Adolescent Drug Use
timeFrame: Number of self reported drug use days from day 169-196
measure: Main Study, Adolescent Drug Use
timeFrame: Number of self reported drug use days from day 197-224
measure: Main Study, Adolescent Drug Use
timeFrame: Number of self reported drug use days from day 225-252
measure: Main Study, Adolescent Drug Use
timeFrame: Number of self reported drug use days from day 253-280
measure: Main Study, Adolescent Drug Use
timeFrame: Number of self reported drug use from days 281-308
measure: Main Study, Adolescent Drug Use
timeFrame: Number of self reported drug use days from day 309-336
measure: Main Study, Adolescent Drug Use
timeFrame: Number of self reported drug use days from day 337-364
measure: Follow Up Study, Drug Use
timeFrame: Number of self reported drug use days 90 days prior assessment
measure: Follow Up Study, Drug Use
timeFrame: Number of self reported drug use days 90 days prior to assessment
Secondary outcomes:
measure: Main Study, Externalizing Behaviors at Baseline
timeFrame: Baseline
measure: Main Study, Externalizing Behavior at 4 Months Post Randomization
timeFrame: 4 months post randomization
measure: Main Study, Externalizing Behavior at 8 Months Post Randomization
timeFrame: 8 months post randomization
measure: Main Study, Externalizing Behavior at 12 Months Post Randomization
timeFrame: 12 months post randomization
measure: Follow Up Study, Externalizing Behavior
timeFrame: 90 days prior to assessment
measure: Main Study, Level of Family Functioning at Baseline
timeFrame: Baseline
measure: Main Study, Level of Family Functioning at 4 Months Post Randomization
timeFrame: 4 months post randomization
measure: Main Study, Level of Family Functioning at 8 Months Post Randomization
timeFrame: 8 months post randomization
measure: Main Study, Level of Family Functioning at 12 Months Post Randomization
timeFrame: 12 months post randomization
measure: Follow Up Study, Level of Family Functioning
timeFrame: 90 days prior assessment
measure: Main Study, Risky Sexual Behaviors at Baseline
timeFrame: Baseline
measure: Main Study, Risky Sexual Behaviors at 4 Months Post Randomization
timeFrame: 4 months post randomization
measure: Main Study, Risky Sexual Behaviors at 8 Months Post Randomization
timeFrame: 8 months post randomization
measure: Main Study, Risky Sexual Behaviors at 12 Months Post Randomization
timeFrame: 12 months post randomization
measure: Follow Up Study, Risky Sexual Behaviors
timeFrame: 90 days prior assessment
Other outcomes:
Locations:
city: Tucson
country: United States
facility: La Frontera Center
state: Arizona
city: Tarzana
country: United States
facility: Tarzana Treatment Center
state: California
city: Thornton
country: United States
facility: Arapahoe House
state: Colorado
city: Jacksonville
country: United States
facility: Gateway Community Services
state: Florida
city: Miami
country: United States
facility: The Villiage
state: Florida
city: Concord
country: United States
facility: Daymark
state: North Carolina
city: Cincinnati
country: United States
facility: The Crossroads Center
state: Ohio
city: Bayamon
country: Puerto Rico
facility: Centro de Salud Mental de la Comunidad de Bayamsn
Study officials:
affiliation: University of Miami
name: Jose Szapocznik, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.