Citation

Horigian VE, Robbins MS, Dominguez R, Ucha J, Rosa CL. Clin. Trials 2010; 7(1): 58-68.

Affiliation

Center for Family Studies, University of Miami, Miami, FL, USA. vhorigian@med.miami.edu.

Copyright

(Copyright © 2010, Society for Clinical Trials, Publisher SAGE Publishing)

DOI

10.1177/1740774509356575

PMID

20156957

PMCID

PMC3163837

Abstract

BACKGROUND: Behavioral intervention research has lagged behind biomedical research in developing principles for defining, categorizing, identifying, reporting, and monitoring adverse events and unanticipated problems. PURPOSE: In this article we present a set of principles for defining adverse events and how they were applied in a large national multi-site family therapy study for substance-using adolescents, The Brief Strategic Family Therapy (BSFT(TM)) Effectiveness Study. METHODS: The BSFT(TM) Effectiveness study tested how BSFT(TM) compares to Treatment as Usual (TAU) for the treatment of drug-abusing adolescents. During protocol development, experts in the BSFT(TM) intervention, medical safety officers, ethicists and senior investigators defined the procedures for identifying, tracking and reporting adverse events for drug using adolescents as well as their family members. During this process the team identified five key guiding principles. RESULTS: The five guiding principles that were used for defining adverse events in this behavioral trial were that that the adverse events should be validated and plausible, and that monitoring systems should assess relatedness, be systematic, and are a shared responsibility. The following non-serious adverse events were identified: arrest, school suspension and drop out, runaway, kicked out of home and violence. The serious adverse events in this study for the identified adolescent participant and all other consented family members were physical or sexual abuse, suicidal behavior, homicidal behavior, hospitalization (drug related or psychiatric related only) and death. The methods used in categorizing, identifying and reporting adverse events in the BSFT(TM) trial are outlined. More than 50% of the adolescent population (277/481 = 57.5 %) experienced an adverse event during the trial. Family members experienced less adverse events, (61/1338 = 4.5%). The most common event for the adolescent group was arrest (164/277= 59.2%), followed by school suspension/dropout (143/277 = 51.6%), and runaway (79/277= 28.5 %). For the family member group, the most common event was violence (25/ 61 = 40.9%) followed by arrest (13/61 = 21.3%). There was a significant difference in the presence of adverse events in family members that were randomized to BSFT(TM) 44/721 (6.1%) when compared to Treatment as Usual 17/617 (2.8%) (p = 0.004). A probable explanation for this is that there were more opportunities to identify adverse events for family members assigned to BSFT(TM) because family members attended therapy sessions. This difference may also represent the risk for family members that participate in an evidence-based family intervention like BSFT(TM). LIMITATIONS: The utility of the principles outside of the BSFT(TM) trial is unknown. CONCLUSIONS: Based on the events reported in this trial, the efforts for monitoring and categorizing adverse events appeared justified and appropriate. The strategies and principles described in this paper may be useful for those developing safety plans for behavioral intervention research, and to family therapy researchers for assessing the safety of behavioral family interventions.

Language: en