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Youth Drug Abuse Family and Cognitive-Behavioral Therapy

This study is currently recruiting participants.
Verified by Johns Hopkins Bloomberg School of Public Health, April 2006

Sponsors and Collaborators: Johns Hopkins Bloomberg School of Public Health
National Institutes of Health (NIH)
Information provided by: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00198874
  Purpose

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.


Condition Intervention Phase
Drug Abuse
Behavioral: Integrated Family and Cognitive-Behavioral Therapy
Phase II

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Dose Comparison, Factorial Assignment, Safety/Efficacy Study
Official Title:   Youth Drug Abuse Family and Cognitive-Behavioral Therapy

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Alcohol use abstinence and frequency
  • Marijuana use abstinence and frequency
  • Other drug use abstinence and frequency

Secondary Outcome Measures:
  • Legal involvement
  • Family functioning
  • Problem solving skill
  • Rational Beliefs
  • Learning Strategy Skill
  • Academic Achievement

Estimated Enrollment:   200
Study Start Date:   January 2005
Estimated Study Completion Date:   June 2008

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   13 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.

-

Exclusion Criteria: Acute psychotic, suicidal, homicidal ideation. Problem severity requiring residential treatment.

-

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198874

Locations
United States, Maryland
Johns Hopkins Bloomberg School of Public Health     Recruiting
      Baltimore, Maryland, United States, 21205
      Contact: William W. Latimer, Ph.D., M.P.H.     410-206-5805     wlatimer@jhsph.edu    

Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
National Institutes of Health (NIH)

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


Publications of Results:

Study ID Numbers:   5R01DA010777-08, 5R01DA010777-08
First Received:   September 13, 2005
Last Updated:   April 6, 2006
ClinicalTrials.gov Identifier:   NCT00198874
Health Authority:   United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
drug abuse  
drug dependence  
treatment  
randomized trial  
stage II study
adolescents
young adults
efficacy study

Study placed in the following topic categories:
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on October 21, 2008




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