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Youth Drug Abuse Family and Cognitive-Behavioral Therapy

Primary Purpose

Drug Abuse

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Integrated Family and Cognitive-Behavioral Therapy
Education
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Abuse focused on measuring drug abuse, drug dependence, treatment, randomized trial, stage II study, adolescents, young adults, efficacy study

Eligibility Criteria

13 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

  • Johns Hopkins Bloomberg School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Psychoeducation

Conitive Behavorial Therapy

Family Therapy

Intergrated Family

Arm Description

Outcomes

Primary Outcome Measures

Marijuana use abstinence and frequency
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.
Other drug use abstinence and frequency
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.
Alcohol use abstinence and frequency
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 Outcome Measures

Legal involvement
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.
Family functioning
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.
Problem solving skill
The Social Problem Solving Inventory (SPSI) assesses respondents' problem solving skill across the five dimensions addressed during the Problem Solving Therapy module of IFCBT.
Rational Beliefs
The Rational Thinking Questionnaire assesses rational and irrational beliefs in relation to drug-related and general life issues.
Learning Strategy Skill
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.
Academic Achievement
The Interview on Sociodemographic Characteristics is administered to collect information on grades, academic achievement, days truant, school behavior problems, detention, suspension, and expulsion.

Full Information

First Posted
September 13, 2005
Last Updated
September 27, 2012
Sponsor
University of Florida
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00198874
Brief Title
Youth Drug Abuse Family and Cognitive-Behavioral Therapy
Official Title
Youth Drug Abuse Family and Cognitive-Behavioral Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institutes of Health (NIH)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse
Keywords
drug abuse, drug dependence, treatment, randomized trial, stage II study, adolescents, young adults, efficacy study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychoeducation
Arm Type
Active Comparator
Arm Title
Conitive Behavorial Therapy
Arm Type
Experimental
Arm Title
Family Therapy
Arm Type
Experimental
Arm Title
Intergrated Family
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Integrated Family and Cognitive-Behavioral Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Drug education curriculum was delivered to participants assigned to this condition.
Primary Outcome Measure Information:
Title
Marijuana use abstinence and frequency
Description
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.
Time Frame
3, 6, 9, 12, and 18 Month Follow-up Assessment
Title
Other drug use abstinence and frequency
Description
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.
Time Frame
3, 6, 9, 12, 18 month Follow-up Assessment
Title
Alcohol use abstinence and frequency
Description
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.
Time Frame
3, 6, 9, 12, and 18 month Follow-up assement
Secondary Outcome Measure Information:
Title
Legal involvement
Description
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.
Time Frame
3,6,9, 12, and 18 month follow-up assessment
Title
Family functioning
Description
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.
Time Frame
3,6,9,12, and 18 month follow-up assessment
Title
Problem solving skill
Description
The Social Problem Solving Inventory (SPSI) assesses respondents' problem solving skill across the five dimensions addressed during the Problem Solving Therapy module of IFCBT.
Time Frame
3,6,9,12, and 18 month assessment
Title
Rational Beliefs
Description
The Rational Thinking Questionnaire assesses rational and irrational beliefs in relation to drug-related and general life issues.
Time Frame
3,6,9,12, and 18 month assessment
Title
Learning Strategy Skill
Description
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.
Time Frame
3,6,9,12, and 18 month assessment
Title
Academic Achievement
Description
The Interview on Sociodemographic Characteristics is administered to collect information on grades, academic achievement, days truant, school behavior problems, detention, suspension, and expulsion.
Time Frame
3,6,9,12, and 18 month assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William W. Latimer, Ph.D., M.P.H.
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bloomberg School of Public Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12957348
Citation
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.
Results Reference
result
PubMed Identifier
12233992
Citation
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.
Results Reference
result

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Youth Drug Abuse Family and Cognitive-Behavioral Therapy

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