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Youth Drug Abuse Family and Cognitive-Behavioral Therapy

27 september 2012 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

296

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21205
        • Johns Hopkins Bloomberg School of Public Health

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

13 år till 21 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

-

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Faktoriell uppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Psykoedukation
Övrig: Education
Drug education curriculum was delivered to participants assigned to this condition.
Experimentell: Conitive Behavorial Therapy
Beteende: Integrated Family and Cognitive-Behavioral 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.
Experimentell: Family Therapy
Beteende: Integrated Family and Cognitive-Behavioral 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.
Experimentell: Intergrated Family
Beteende: Integrated Family and Cognitive-Behavioral 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Alcohol use abstinence and frequency
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Family functioning
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Florida

Samarbetspartners

National Institutes of Health (NIH)

Utredare

  • Huvudutredare: William W. Latimer, Ph.D., M.P.H., Johns Hopkins Bloomberg School of Public Health

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2005

Primärt slutförande (Faktisk)

1 juni 2010

Avslutad studie (Faktisk)

1 december 2011

Studieregistreringsdatum

Först inskickad

13 september 2005

Först inskickad som uppfyllde QC-kriterierna

13 september 2005

Första postat (Uppskatta)

20 september 2005

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

28 september 2012

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 september 2012

Senast verifierad

1 september 2012

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 5R01DA010777-08 (U.S.S. NIH-anslag/kontrakt)

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