- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00198874
Youth Drug Abuse Family and Cognitive-Behavioral Therapy
27. september 2012 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
296
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Maryland
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Baltimore, Maryland, Forenede Stater, 21205
- Johns Hopkins Bloomberg School of Public Health
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
13 år til 21 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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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Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Psykoedukation
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Drug education curriculum was delivered to participants assigned to this condition.
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Eksperimentel: Conitive Behavorial Therapy
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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.
|
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Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Alcohol use abstinence and frequency
Tidsramme: 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.
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3, 6, 9, 12, and 18 month Follow-up assement
|
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Marijuana use abstinence and frequency
Tidsramme: 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.
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3, 6, 9, 12, and 18 Month Follow-up Assessment
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Other drug use abstinence and frequency
Tidsramme: 3, 6, 9, 12, 18 month Follow-up Assessment
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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.
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3, 6, 9, 12, 18 month Follow-up Assessment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Family functioning
Tidsramme: 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.
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3,6,9,12, and 18 month follow-up assessment
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Learning Strategy Skill
Tidsramme: 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.
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3,6,9,12, and 18 month assessment
|
|
Legal involvement
Tidsramme: 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.
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3,6,9, 12, and 18 month follow-up assessment
|
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Problem solving skill
Tidsramme: 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.
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3,6,9,12, and 18 month assessment
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Rational Beliefs
Tidsramme: 3,6,9,12, and 18 month assessment
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The Rational Thinking Questionnaire assesses rational and irrational beliefs in relation to drug-related and general life issues.
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3,6,9,12, and 18 month assessment
|
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Academic Achievement
Tidsramme: 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.
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3,6,9,12, and 18 month assessment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: William W. Latimer, Ph.D., M.P.H., Johns Hopkins Bloomberg School of Public Health
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2005
Primær færdiggørelse (Faktiske)
1. juni 2010
Studieafslutning (Faktiske)
1. december 2011
Datoer for studieregistrering
Først indsendt
13. september 2005
Først indsendt, der opfyldte QC-kriterier
13. september 2005
Først opslået (Skøn)
20. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. september 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. september 2012
Sidst verificeret
1. september 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 5R01DA010777-08 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .