Principles for defining adverse events in behavioral intervention research: Lessons from a family-focused adolescent drug abuse trial

Viviana Horigian, Michael S. Robbins, Roberto Dominguez, Jessica Ucha, Carmen L. Rosa

Research output: Contribution to journalArticle

14 Citations (Scopus)

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 trade;) Effectiveness Study. Methods The BSFTtrade; Effectiveness study tested how BSFTtrade; compares to Treatment as Usual (TAU) for the treatment of drug-abusing adolescents. During protocol development, experts in the BSFTtrade; 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 BSFTtrade; 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 trade; 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 BSFTtrade; 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 BSFTtrade;. Limitations The utility of the principles outside of the BSFTtrade; 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.

Original languageEnglish
Pages (from-to)58-68
Number of pages11
JournalClinical Trials
Volume7
Issue number1
DOIs
StatePublished - Feb 1 2010

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Behavioral Research
Substance-Related Disorders
Family Therapy
Homeless Youth
Safety
Violence
Suspensions
Student Dropouts
Research Personnel
Ethicists
Sex Offenses
Therapeutics
Drug-Related Side Effects and Adverse Reactions
Pharmaceutical Preparations
Psychiatry
Biomedical Research
Hospitalization

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology

Cite this

Principles for defining adverse events in behavioral intervention research : Lessons from a family-focused adolescent drug abuse trial. / Horigian, Viviana; Robbins, Michael S.; Dominguez, Roberto; Ucha, Jessica; Rosa, Carmen L.

In: Clinical Trials, Vol. 7, No. 1, 01.02.2010, p. 58-68.

Research output: Contribution to journalArticle

Horigian, Viviana ; Robbins, Michael S. ; Dominguez, Roberto ; Ucha, Jessica ; Rosa, Carmen L. / Principles for defining adverse events in behavioral intervention research : Lessons from a family-focused adolescent drug abuse trial. In: Clinical Trials. 2010 ; Vol. 7, No. 1. pp. 58-68.
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title = "Principles for defining adverse events in behavioral intervention research: Lessons from a family-focused adolescent drug abuse trial",
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 trade;) Effectiveness Study. Methods The BSFTtrade; Effectiveness study tested how BSFTtrade; compares to Treatment as Usual (TAU) for the treatment of drug-abusing adolescents. During protocol development, experts in the BSFTtrade; 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 BSFTtrade; 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 trade; 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 BSFTtrade; 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 BSFTtrade;. Limitations The utility of the principles outside of the BSFTtrade; 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.",
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N2 - 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 trade;) Effectiveness Study. Methods The BSFTtrade; Effectiveness study tested how BSFTtrade; compares to Treatment as Usual (TAU) for the treatment of drug-abusing adolescents. During protocol development, experts in the BSFTtrade; 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 BSFTtrade; 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 trade; 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 BSFTtrade; 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 BSFTtrade;. Limitations The utility of the principles outside of the BSFTtrade; 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.

AB - 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 trade;) Effectiveness Study. Methods The BSFTtrade; Effectiveness study tested how BSFTtrade; compares to Treatment as Usual (TAU) for the treatment of drug-abusing adolescents. During protocol development, experts in the BSFTtrade; 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 BSFTtrade; 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 trade; 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 BSFTtrade; 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 BSFTtrade;. Limitations The utility of the principles outside of the BSFTtrade; 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.

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