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Brief Strategic Family Therapy (BSFT) for Addiction (BSFT Trial)

Phase 3
Waitlist Available
Led By Jose Szapocznik, Ph.D.
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post randomization
Awards & highlights
Pivotal Trial
No Placebo-Only Group

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.

Eligible Conditions
  • Addiction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Follow Up Study, Drug Use
Main Study, Adolescent Drug Use
Secondary study objectives
Follow Up Study, Externalizing Behavior
Follow Up Study, Level of Family Functioning
Follow Up Study, Risky Sexual Behaviors
+12 more

Side effects data

From 2011 Phase 3 trial • 480 Patients • NCT00095303
34%
Arrest
30%
School suspension
19%
Runaway
10%
Violence
3%
Hospitalization
2%
Homicidal Behavior
2%
Suicidal Behavior
2%
Kicked out of home
1%
Physical/ Sexual Abuse
1%
Other Unexpected Adverse Event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment as Usual
BSFT

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Brief Strategic Family Therapy (BSFT)Experimental Treatment1 Intervention
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).
Group II: Treatment as Usual (TAU)Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brief Strategic Family Therapy (BSFT)
2004
Completed Phase 3
~480

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
947 Previous Clinical Trials
427,225 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,576 Previous Clinical Trials
3,285,935 Total Patients Enrolled
Oregon Research InstituteOTHER
86 Previous Clinical Trials
62,414 Total Patients Enrolled
~23 spots leftby Nov 2025
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