- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT00198874
Youth Drug Abuse Family and Cognitive-Behavioral Therapy
2012. szeptember 27. frissítette: 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.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
296
Fázis
- 2. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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-
Maryland
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Baltimore, Maryland, Egyesült Államok, 21205
- Johns Hopkins Bloomberg School of Public Health
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
13 év (Gyermek, Felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
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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Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Tényező hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Aktív összehasonlító: Pszichoedukáció
|
Drug education curriculum was delivered to participants assigned to this condition.
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Kísérleti: 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.
|
Kísérleti: Family 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.
|
Kísérleti: 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.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Alcohol use abstinence and frequency
Időkeret: 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
Időkeret: 3, 6, 9, 12, and 18 Month Follow-up Assessment
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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
Időkeret: 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
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Family functioning
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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.
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3,6,9,12, and 18 month assessment
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Academic Achievement
Időkeret: 3,6,9,12, and 18 month assessment
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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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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: William W. Latimer, Ph.D., M.P.H., Johns Hopkins Bloomberg School of Public Health
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Általános kiadványok
- 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.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2005. január 1.
Elsődleges befejezés (Tényleges)
2010. június 1.
A tanulmány befejezése (Tényleges)
2011. december 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2005. szeptember 13.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2005. szeptember 13.
Első közzététel (Becslés)
2005. szeptember 20.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
2012. szeptember 28.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2012. szeptember 27.
Utolsó ellenőrzés
2012. szeptember 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 5R01DA010777-08 (Az Egyesült Államok NIH támogatása/szerződése)
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
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