- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00198874
Youth Drug Abuse Family and Cognitive-Behavioral Therapy
2012년 9월 27일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
296
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Maryland
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Baltimore, Maryland, 미국, 21205
- Johns Hopkins Bloomberg School of Public Health
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
13년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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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공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 심리 교육
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Drug education curriculum was delivered to participants assigned to this condition.
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실험적: 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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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Alcohol use abstinence and frequency
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Family functioning
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: William W. Latimer, Ph.D., M.P.H., Johns Hopkins Bloomberg School of Public Health
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2005년 1월 1일
기본 완료 (실제)
2010년 6월 1일
연구 완료 (실제)
2011년 12월 1일
연구 등록 날짜
최초 제출
2005년 9월 13일
QC 기준을 충족하는 최초 제출
2005년 9월 13일
처음 게시됨 (추정)
2005년 9월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 9월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 9월 27일
마지막으로 확인됨
2012년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
약물 남용에 대한 임상 시험
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University Hospitals Cleveland Medical CenterWashington University School of Medicine; Case Western Reserve University; Papua New Guinea... 그리고 다른 협력자들모병Mass Drug Administration에 의한 림프 사상충증 제거 | 림프 사상충증에 대한 대량 의약품 관리의 모니터링 및 평가 | 림프 사상충증에 대한 대량 의약품 허가 승인파푸아 뉴기니
Education에 대한 임상 시험
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University of SheffieldUniversity of Liverpool; University of Manchester; University of Melbourne모집하지 않고 적극적으로
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University of OxfordBeijing Normal University; Beijing Stars and Rain Education Institute for Autism완전한아동 학대 | 부모-자녀 관계 | 자폐 스펙트럼 장애 | 육아 | 아동 행동 문제 | 가족 관계 | 정신 건강 문제중국
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The University of Texas Health Science Center,...National Cancer Institute (NCI)모집하지 않고 적극적으로