Youth Drug Abuse Family and Cognitive-Behavioral Therapy
September 27, 2012 updated by: University of Florida
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
296
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins Bloomberg School of Public Health
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Psychoeducation
|
Drug education curriculum was delivered to participants assigned to this condition.
|
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Experimental: Conitive Behavorial 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.
|
|
Experimental: Family 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.
|
|
Experimental: Intergrated Family
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3, 6, 9, 12, and 18 month Follow-up assement
|
|
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.
|
3, 6, 9, 12, and 18 Month Follow-up Assessment
|
|
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, 6, 9, 12, 18 month Follow-up Assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3,6,9,12, and 18 month follow-up assessment
|
|
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.
|
3,6,9,12, and 18 month assessment
|
|
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.
|
3,6,9, 12, and 18 month follow-up assessment
|
|
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.
|
3,6,9,12, and 18 month assessment
|
|
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.
|
3,6,9,12, and 18 month assessment
|
|
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.
|
3,6,9,12, and 18 month assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: William W. Latimer, Ph.D., M.P.H., Johns Hopkins Bloomberg School of Public Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Latimer WW, Winters KC, D'Zurilla T, Nichols M. Integrated family and cognitive-behavioral therapy for adolescent substance abusers: a stage I efficacy study. Drug Alcohol Depend. 2003 Sep 10;71(3):303-17. doi: 10.1016/s0376-8716(03)00171-6.
- Latimer WW, Stone AL, Voight A, Winters KC, August GJ. Gender differences in psychiatric comorbidity among adolescents with substance use disorders. Exp Clin Psychopharmacol. 2002 Aug;10(3):310-5. doi: 10.1037//1064-1297.10.3.310.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
September 28, 2012
Last Update Submitted That Met QC Criteria
September 27, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01DA010777-08 (U.S. NIH Grant/Contract)
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