Youth Drug Abuse Family and Cognitive-Behavioral Therapy
2012年9月27日 更新者: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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
296
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Maryland
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Baltimore、Maryland、アメリカ、21205
- Johns Hopkins Bloomberg School of Public Health
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
13年~21年 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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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研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:階乗代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ:心理教育
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Drug education curriculum was delivered to participants assigned to this condition.
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実験的: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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実験的: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.
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実験的:Intergrated Family
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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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Alcohol use abstinence and frequency
時間枠:3, 6, 9, 12, and 18 month Follow-up assement
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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
時間枠: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.
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3, 6, 9, 12, and 18 Month Follow-up Assessment
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Other drug use abstinence and frequency
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Family functioning
時間枠:3,6,9,12, and 18 month follow-up assessment
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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
時間枠:3,6,9,12, and 18 month assessment
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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
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Legal involvement
時間枠:3,6,9, 12, and 18 month follow-up assessment
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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
時間枠:3,6,9,12, and 18 month assessment
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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
時間枠: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
時間枠: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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者:William W. Latimer, Ph.D., M.P.H.、Johns Hopkins Bloomberg School of Public Health
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2005年1月1日
一次修了 (実際)
2010年6月1日
研究の完了 (実際)
2011年12月1日
試験登録日
最初に提出
2005年9月13日
QC基準を満たした最初の提出物
2005年9月13日
最初の投稿 (見積もり)
2005年9月20日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年9月28日
QC基準を満たした最後の更新が送信されました
2012年9月27日
最終確認日
2012年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Educationの臨床試験
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University of SheffieldUniversity of Liverpool; University of Manchester; University of Melbourne積極的、募集していない