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Youth Drug Abuse Family and Cognitive-Behavioral Therapy

27. září 2012 aktualizováno: 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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

296

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Maryland
      • Baltimore, Maryland, Spojené státy, 21205
        • Johns Hopkins Bloomberg School of Public Health

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

13 let až 21 let (Dítě, Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

-

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Faktorové přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Psychoedukace
Drug education curriculum was delivered to participants assigned to this condition.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Alcohol use abstinence and frequency
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Family functioning
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. ledna 2005

Primární dokončení (Aktuální)

1. června 2010

Dokončení studie (Aktuální)

1. prosince 2011

Termíny zápisu do studia

První předloženo

13. září 2005

První předloženo, které splnilo kritéria kontroly kvality

13. září 2005

První zveřejněno (Odhad)

20. září 2005

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

28. září 2012

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. září 2012

Naposledy ověřeno

1. září 2012

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 5R01DA010777-08 (Grant/smlouva NIH USA)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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