Phase 3
N=480
Brief Strategic Family Therapy for Adolescent Drug Abusers
Substance Abuse
Bottom Line
View on ClinicalTrials.gov: NCT00095303 ↗Enrolled (actual)
480
Serious AEs
6.7%
Results posted
Jul 2015
Primary outcome: Primary: Main Study, Adolescent Drug Use — 3; 3 days of drug use 28 days prior baseline — p=.27
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brief Strategic Family Therapy (BSFT) (Behavioral); Treatment as Usual (Behavioral)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Main Study, Adolescent Drug Use |
2; 3.5 | — |
| PRIMARY Main Study, Adolescent Drug Use |
2; 3.5 | — |
| PRIMARY Main Study, Adolescent Drug Use |
2; 3.5 | — |
| PRIMARY Main Study, Adolescent Drug Use |
2; 3.5 | — |
| PRIMARY Main Study, Adolescent Drug Use |
2; 3.5 | — |
| PRIMARY Main Study, Adolescent Drug Use |
2; 3.5 | — |
| PRIMARY Main Study, Adolescent Drug Use |
2; 3.5 | — |
| PRIMARY Main Study, Adolescent Drug Use |
2; 3.5 | — |
| PRIMARY Main Study, Adolescent Drug Use |
2; 3.5 | — |
| PRIMARY Main Study, Adolescent Drug Use |
2; 3.5 | — |
| PRIMARY Main Study, Adolescent Drug Use |
2; 3.5 | — |
| PRIMARY Main Study, Adolescent Drug Use |
2; 3.5 | — |
| PRIMARY Main Study, Adolescent Drug Use |
2; 3.5 | — |
| PRIMARY Main Study, Adolescent Drug Use |
2; 3.5 | — |
| PRIMARY Follow Up Study, Drug Use |
8; 10 | — |
| PRIMARY Follow Up Study, Drug Use |
8; 10 | — |
| SECONDARY Main Study, Externalizing Behaviors at Baseline |
-.004; .004 | .26 |
| SECONDARY Main Study, Externalizing Behavior at 4 Months Post Randomization |
-.36; -.21 | — |
| SECONDARY Main Study, Externalizing Behavior at 8 Months Post Randomization |
-.45; -.39 | — |
| SECONDARY Main Study, Externalizing Behavior at 12 Months Post Randomization |
-.45; -.52 | — |
| SECONDARY Follow Up Study, Externalizing Behavior |
3.1; 3.5 | <.006 sig |
| SECONDARY Main Study, Level of Family Functioning at Baseline |
-0.03; 0.04 | .015 sig |
| SECONDARY Main Study, Level of Family Functioning at 4 Months Post Randomization |
0.15; 0.21 | — |
| SECONDARY Main Study, Level of Family Functioning at 8 Months Post Randomization |
0.31; 0.25 | — |
| SECONDARY Main Study, Level of Family Functioning at 12 Months Post Randomization |
0.35; 0.14 | — |
| SECONDARY Follow Up Study, Level of Family Functioning |
13.2; 12.4 | .12 |
| SECONDARY Main Study, Risky Sexual Behaviors at Baseline |
.95; 1.00 | .12 |
| SECONDARY Main Study, Risky Sexual Behaviors at 4 Months Post Randomization |
.89; 1.18 | — |
| SECONDARY Main Study, Risky Sexual Behaviors at 8 Months Post Randomization |
1.01; 1.32 | — |
| SECONDARY Main Study, Risky Sexual Behaviors at 12 Months Post Randomization |
1.30; 1.44 | — |
| SECONDARY Follow Up Study, Risky Sexual Behaviors |
2.06; 2.20 | .23 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00095303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.