Youth Drug Abuse Family and Cognitive-Behavioral Therapy

Official Title: “Youth Drug Abuse Family and Cognitive-Behavioral Therapy”

This Stage II study is in response to NIDA's Behavioral Therapies Development Program (PA-99-107). A randomized clinical trial is proposed to evaluate the direct, mediated, and moderated effects of Integrated Family and Cognitive-Behavioral Therapy (IFCBT), a multisystems treatment for adolescent drug abuse with promising efficacy results. In the first study aim, we seek to evaluate the separate and possibly synergistic effects of family systems and cognitive-behavioral IFCBT components on posttreatment drug abuse problem severity, problem behavior, psychiatric distress, and academic achievement of adolescent drug abusers. Innovative analytic strategies are subsequently used to evaluate the degree to which successful outcomes are attributable to specific familial and cognitive-behavioral change processes targeted by IFCBT components. The possibility of effect-modification also is considered, with a focus on neurocognitive, psychiatric comorbidity, and demographic factors. Namely, we seek to understand how variations in specific client characteristics, such as executive dysfunctions or psychiatric comorbidity, might explain why treatments work for some drug abusing youths but not others. In addition to promising findings on IFCBT efficacy, this Stage II proposal benefits from the development and Stage I study application of (a) treatment manuals; (b) therapist training procedures; (c) therapist adherence and competence tools; (d) a neuropsychological battery to assess cognitive functions; (e) a psychodiagnostic battery to assess comorbid psychiatric disorders; and (f) a study assessment battery comprised of therapeutic process and outcome measures. This revised application has sought to address well-taken concerns cited by the reviewers while maintaining proposal strengths. The lack of adolescent drug treatment research continues to be a serious gap in the addictions literature despite alarmingly high rates of drug abuse among youth and the range of morbidities and mortality that result nationwide. If successful, this project should help to identify specific behavior change processes targeted by family systems and cognitive-behavioral treatments that foster subsequent reductions in drug use and problem behavior among recovering youth. Neurocognitive and psychiatric influences on adolescent drug treatment outcomes appear to be significant yet are poorly understood. Increasing our understanding of relationships between client characteristics, skill development during treatments, and subsequent outcomes should also help to improve adolescent drug treatments.

This Stage II study is in response to NIDA's Behavioral Therapies Development Program (PA-99-107). A randomized clinical trial is proposed to evaluate the direct, mediated, and moderated effects of Integrated Family and Cognitive-Behavioral Therapy (IFCBT), a multisystems treatment for adolescent drug abuse with promising efficacy results. In the first study aim, we seek to evaluate the separate and possibly synergistic effects of family systems and cognitive-behavioral IFCBT components on posttreatment drug abuse problem severity, problem behavior, psychiatric distress, and academic achievement of adolescent drug abusers. Innovative analytic strategies are subsequently used to evaluate the degree to which successful outcomes are attributable to specific familial and cognitive-behavioral change processes targeted by IFCBT components. The possibility of effect-modification also is considered, with a focus on neurocognitive, psychiatric comorbidity, and demographic factors. Namely, we seek to understand how variations in specific client characteristics, such as executive dysfunctions or psychiatric comorbidity, might explain why treatments work for some drug abusing youths but not others. In addition to promising findings on IFCBT efficacy, this Stage II proposal benefits from the development and Stage I study application of (a) treatment manuals; (b) therapist training procedures; (c) therapist adherence and competence tools; (d) a neuropsychological battery to assess cognitive functions; (e) a psychodiagnostic battery to assess comorbid psychiatric disorders; and (f) a study assessment battery comprised of therapeutic process and outcome measures. This revised application has sought to address well-taken concerns cited by the reviewers while maintaining proposal strengths. The lack of adolescent drug treatment research continues to be a serious gap in the addictions literature despite alarmingly high rates of drug abuse among youth and the range of morbidities and mortality that result nationwide. If successful, this project should help to identify specific behavior change processes targeted by family systems and cognitive-behavioral treatments that foster subsequent reductions in drug use and problem behavior among recovering youth. Neurocognitive and psychiatric influences on adolescent drug treatment outcomes appear to be significant yet are poorly understood. Increasing our understanding of relationships between client characteristics, skill development during treatments, and subsequent outcomes should also help to improve adolescent drug treatments.

Intervention(s) in this Clinical Trial

• Behavioral: Integrated Family and Cognitive-Behavioral Therapy
  • The family therapy component of IFCBT includes engagement, active treatment, and maintenance phases. The cognitive program focuses on harmful effects of drugs and strategies to better manage drug abuse risks. The cognitive-behavioral program introduces youths to problem-solving behavior change principles and study skills to promote school achievement.
• Other: Education
  • Drug education curriculum was delivered to participants assigned to this condition.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Psychoeducation
• Experimental: Conitive Behavorial Therapy
• Experimental: Family Therapy
• Experimental: Intergrated Family

Primary Measures

• Marijuana use abstinence and frequency
  • Time Frame: 3, 6, 9, 12, and 18 Month Follow-up Assessment
    Safety Issue?: No
• Other drug use abstinence and frequency
  • Time Frame: 3, 6, 9, 12, 18 month Follow-up Assessment
    Safety Issue?: No
• Alcohol use abstinence and frequency
  • Time Frame: 3, 6, 9, 12, and 18 month Follow-up assement
    Safety Issue?: No

Secondary Measures

• Legal involvement
  • Time Frame: 3,6,9, 12, and 18 month follow-up assessment
    Safety Issue?: No
• Family functioning
  • Time Frame: 3,6,9,12, and 18 month follow-up assessment
    Safety Issue?: No
• Problem solving skill
  • Time Frame: 3,6,9,12, and 18 month assessment
    Safety Issue?: No
• Rational Beliefs
  • Time Frame: 3,6,9,12, and 18 month assessment
    Safety Issue?: No
• Learning Strategy Skill
  • Time Frame: 3,6,9,12, and 18 month assessment
    Safety Issue?: No
• Academic Achievement
  • Time Frame: 3,6,9,12, and 18 month assessment
    Safety Issue?: No

• Inclusion Criteria: Adolescents and young adults aged 13 to 21 years old who have significant drug-related problems or meet diagnostic criteria for drug abuse/dependence.
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• Exclusion Criteria: Acute psychotic, suicidal, homicidal ideation. Problem severity requiring residential treatment.
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Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: 21 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Johns Hopkins Bloomberg School of Public Health Other

Overall Clinical Trial Officials and Contacts

William W. Latimer, Ph.D., M.P.H. Principal Investigator Johns Hopkins Bloomberg School of Public Health  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00198874

Study ID Number: 5R01DA010777-08

ClinicalTrials.gov Identifier: NCT00198874

Health Authority: United States: Institutional Review Board