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Completed

NCT Number: NCT00198874

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.

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Key information

Conditions

Drug Abuse Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

13 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

Integrated Family and Cognitive-Behavioral Therapy

Behavioral

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.

Education

Other

Drug education curriculum was delivered to participants assigned to this condition.

Primary outcomes

  1. Marijuana use abstinence and frequency

    Time frame: 3, 6, 9, 12, and 18 Month Follow-up Assessment

    The Personal Experience Inventory (PEI) is a youth self-report drug use inventory that assesses the frequency and quantity of substance use and drug abuse risk factors, such as deviant behavior and peer drug use.

  2. Other drug use abstinence and frequency

    Time frame: 3, 6, 9, 12, 18 month Follow-up Assessment

    The Adolescent Stage of Change Scale (ASCS) consists of items to measure youths' motivation to change drug use behavior. Urine will also be analyzed for the presence of drugs, such as cannabinoids, cocaine, opiates, amphetamine, methamphetamine, MDMA, benzodiazepines, and barbiturates using gas chromatography/mass spectrometry methods.

  3. Alcohol use abstinence and frequency

    Time frame: 3, 6, 9, 12, and 18 month Follow-up assement

    Personal Experience Inventory (PEI) is a youth self-report drug use inventory that assesses the frequency and quantity of substance use and drug abuse risk factors, such as deviant behavior and peer drug use.

Secondary outcomes

  1. Legal involvement

    Time frame: 3,6,9, 12, and 18 month follow-up assessment

    The parent and adolescent versions of the Missouri Assessment for Genetics Interview for Children (MAGIC) address diagnostic symptoms associated with DSM-IV criteria including conduct disorder and antisocial personality disorder and includes questions on legal involvement.

  2. Family functioning

    Time frame: 3,6,9,12, and 18 month follow-up assessment

    The Family Assessment Measure (FAM) is a self-report tool for parents and children that measures change processes targeted by the family systems component of IFCBT, including appropriate role performance, parental control, and communication.

  3. Problem solving skill

    Time frame: 3,6,9,12, and 18 month assessment

    The Social Problem Solving Inventory (SPSI) assesses respondents' problem solving skill across the five dimensions addressed during the Problem Solving Therapy module of IFCBT.

  4. Rational Beliefs

    Time frame: 3,6,9,12, and 18 month assessment

    The Rational Thinking Questionnaire assesses rational and irrational beliefs in relation to drug-related and general life issues.

  5. Learning Strategy Skill

    Time frame: 3,6,9,12, and 18 month assessment

    The Motivated Strategies for Learning Questionnaire (MSLQ) assesses adolescents' motivation to learn in school and use of effective learning strategies that are addressed during the Learning Strategy Training module of IFCBT.

  6. Academic Achievement

    Time frame: 3,6,9,12, and 18 month assessment

    The Interview on Sociodemographic Characteristics is administered to collect information on grades, academic achievement, days truant, school behavior problems, detention, suspension, and expulsion.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2005
Primary completion
2010
Study completion
2011
First posted
Sep 20, 2005
Registry last updated
Sep 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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