Youth Drug Abuse Family and Cognitive-Behavioral Therapy

NCT00198874 | Completed Phase 2

• 1 other identifier: 5R01DA010777-08
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Abuse

Keywords

drug abuse; drug dependence; treatment; randomized trial; stage II study; adolescents; young adults; efficacy study

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

  3, 6, 9, 12, 18 month Follow-up Assessment

• 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.

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

Secondary Outcomes (6)

• Legal involvement

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

• Family functioning

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

• Problem solving skill

  3,6,9,12, and 18 month assessment

• Rational Beliefs

  3,6,9,12, and 18 month assessment

• Learning Strategy Skill

  3,6,9,12, and 18 month assessment

Study Arms (4)

Psychoeducation

ACTIVE COMPARATOR

Other: Education

Conitive Behavorial Therapy

EXPERIMENTAL

Behavioral: Integrated Family and Cognitive-Behavioral Therapy

Family Therapy

EXPERIMENTAL

Behavioral: Integrated Family and Cognitive-Behavioral Therapy

Intergrated Family

EXPERIMENTAL

Behavioral: Integrated Family and Cognitive-Behavioral Therapy

Interventions

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.

Conitive Behavorial Therapy; Family Therapy; Intergrated Family

Education OTHER

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

Psychoeducation

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• University of Florida: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

• 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.

  PMID: 12957348 RESULT

• 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.

  PMID: 12233992 RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Cognitive Behavioral Therapy; Educational Status

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Socioeconomic Factors; Population Characteristics

Study Officials

• William W. Latimer, Ph.D., M.P.H.

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2005
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2011
• Last Updated: September 28, 2012

Record last verified: 2012-09

Locations

US (1)