Neurological Influences on Drug Prevention Intervention
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ClinicalTrials.gov Identifier: NCT00198939 |
Recruitment Status
:
Completed
First Posted
: September 20, 2005
Last Update Posted
: September 28, 2012
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Condition or disease | Intervention/treatment | Phase |
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Youths At-risk for Drug Use/Abuse | Behavioral: Integrated Family and Cognitive-Behavioral Drug Prevention Intervention Other: Psychoeducation | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 330 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Neurological Influences on Drug Prevention Intervention |
Study Start Date : | January 2005 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2011 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Psychoeducation
Drug education curriculum was delivered to participants assigned to this condition.
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Other: Psychoeducation
Drug education curriculum was delivered to participants assigned to this condition.
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Experimental: Conitive Behavorial Therapy
The cognitive-behavioral program introduces youths to problem-solving behavior change principles and study skills to promote school achievement.
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Behavioral: Integrated Family and Cognitive-Behavioral Drug Prevention Intervention
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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Experimental: Family Therapy
Participants assigned to the Family Therapy arm received a family-centered intervention to support targeted adolescent behavior change. The family therapy component of IFCBT includes engagement, active treatment, and maintenance phases.
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Behavioral: Integrated Family and Cognitive-Behavioral Drug Prevention Intervention
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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Experimental: Intergrated Family and Cognitve Behavioral Therapy
Participants assigned to the IFCBT arm received the Cognitive Behavioral Therapy and Family Therapy intervention components.
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Behavioral: Integrated Family and Cognitive-Behavioral Drug Prevention Intervention
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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- Alcohol use abstinence and frequency [ Time Frame: 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.
- Marijuana use abstinence and frequency [ Time Frame: 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.
- Other drug use abstinence and frequency [ Time Frame: 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.
- Academic achievement [ Time Frame: 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.
- Family functioning [ Time Frame: 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.
- Learning Strategy Skill [ Time Frame: 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.
- Legal Involvement [ Time Frame: 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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Ages Eligible for Study: | 11 Years to 15 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 11 to 15 year old middle school students
Exclusion Criteria:
- Acute suicidal, homicidal, psychotic ideation
- Problem severity indicating outpatient or residential treatment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198939
United States, Maryland | |
Johns Hopkins Bloomberg School of Public Health | |
Baltimore, Maryland, United States, 21205 |
Principal Investigator: | William W. Latimer, PhD, MPH | Johns Hopkins Bloomberg School of Public Health |
Publications:
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00198939 History of Changes |
Other Study ID Numbers: |
5R01DA015075-03 ( U.S. NIH Grant/Contract ) |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | September 28, 2012 |
Last Verified: | September 2012 |
Keywords provided by University of Florida:
drug prevention adolescence middle school randomized trial family therapy |
cognitive-behavioral efficacy selected youth indicated youth |