Youths At-risk for Drug Use/AbusePhase 1/2NCT00198939
Neurological Influences on Drug Prevention Intervention
A Phase 1/2 study testing Integrated Family and Cognitive-Behavioral Drug Prevention Intervention and Psychoeducation in people with Youths At-risk for Drug Use/Abuse, run by University of Florida at 1 site in United States.
Trial summary
In this R01 study, a randomized clinical trial is proposed to evaluate the efficacy of a drug abuse prevention intervention for indicated middle school youth that coordinates family and teen-based components. Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Youths At-risk for Drug Use/Abuse
- What is being tested?
- Integrated Family and Cognitive-Behavioral Drug Prevention Intervention and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Dec 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 11 to 15 year old middle school students
Who cannot join
- Acute suicidal, homicidal, psychotic ideation
- Problem severity indicating outpatient or residential treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
In this R01 study, a randomized clinical trial is proposed to evaluate the efficacy of a drug abuse prevention intervention for indicated middle school youth that coordinates family and teen-based components. The Family Management Intervention is comprised of a parent-focused curriculum to foster parenting skills followed by brief family therapy to foster adaptive family communication and age-appropriate roles. The Teen Achievement Intervention is comprised of a clinician-delivered learning strategy curriculum to foster academic achievement followed by a similar yet peer-facilitated curriculum to foster self-efficacy and prosocial peer networks. In the first study aim, we seek to evaluate the separate and possibly synergistic effects of the Family Management and Teen Achievement components on post intervention drug use, problem behavior, psychological distress, and academic achievement of indicated youth. Innovative analytic strategies are subsequently used to elucidate mediated pathways by which the interventions might reduce drug involvement and problem behavior by promoting changes in targeted skills and behavior change processes. The possibility of effect-modification also is considered, with a focus on neurocognitive, internalizing/externalizing, and demographic factors, in an effort to discern why interventions work for some youth but not others. This application revision has sought to address well-taken concerns cited by the reviewers while maintaining proposal strengths. In response to a key limitation, this revision includes further specification of anticipated relationships between neurocognitive variables, skill acquisition levels, and prevention intervention outcomes among indicated youth. Study hypotheses on specific neurocognitive effects are informed by empirical findings and the clinical experience of investigative team members specializing in neuropsychology. If successful, this project should improve prevention practices by identifying malleable behavior change processes fostered by effective interventions. Improving our understanding of how individual characteristics of indicated youth, such as neurocognitive deficits or externalizing problems, influence the development of skills during interventions and subsequent outcomes may also help to improve existing prevention interventions. The significance of the proposed study is underscored further by the substantial size of the targeted population of indicated youth, and the range of morbidities and mortality that often result when early warning signs of drug abuse are not addressed.
- Conditions
- Youths At-risk for Drug Use/Abuse
- Being tested
- Integrated Family and Cognitive-Behavioral Drug Prevention Intervention, Psychoeducation
- Keywords
- drug prevention, adolescence, middle school, randomized trial, family therapy, cognitive-behavioral, efficacy, selected youth, indicated youth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Family and Cognitive-Behavioral Drug Prevention InterventionBehavioural
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.
PsychoeducationOther
Drug education curriculum was delivered to participants assigned to this condition.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation | Active comparator | Drug education curriculum was delivered to participants assigned to this condition. Receives: Other: Psychoeducation |
| Conitive Behavorial Therapy | Experimental | The cognitive-behavioral program introduces youths to problem-solving behavior change principles and study skills to promote school achievement. Receives: Behavioral: Integrated Family and Cognitive-Behavioral Drug Prevention Intervention |
| Family Therapy | Experimental | 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. Receives: Behavioral: Integrated Family and Cognitive-Behavioral Drug Prevention Intervention |
| Intergrated Family and Cognitve Behavioral Therapy | Experimental | Participants assigned to the IFCBT arm received the Cognitive Behavioral Therapy and Family Therapy intervention components. Receives: Behavioral: Integrated Family and Cognitive-Behavioral Drug Prevention Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use abstinence and frequency
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.
Measured: 3, 6, 9, 12, and 18 month Follow-up assement
Marijuana use abstinence and frequency
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.
Measured: 3, 6, 9, 12, and 18 Month Follow-up Assessment
Other drug use abstinence and frequency
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.
Measured: 3, 6, 9, 12, 18 month Follow-up Assessment
Secondary outcomes (4)
Academic achievement
The Interview on Sociodemographic Characteristics is administered to collect information on grades, academic achievement, days truant, school behavior problems, detention, suspension, and expulsion.
Measured: 3,6,9,12, and 18 month assessment
Family functioning
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.
Measured: 3,6,9,12, and 18 month follow-up assessment
Learning Strategy Skill
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.
Measured: 3,6,9,12, and 18 month assessment
Legal Involvement
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.
Measured: 3,6,9, 12, and 18 month follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Youths At-risk for Drug Use/AbuseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- William W. Latimer, PhD, MPH, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198939
- Sponsor's protocol ID
- 5R01DA015075-03
- Other IDs
- 5R01DA015075-03
- Status last verified
- Sep 2012
- First submitted
- 13 Sep 2005
- Last updated
- 28 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12957348
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Influences on Drug Prevention Intervention
- ClinicalTrials.gov ID
- NCT00198939
- Acronym / sponsor ID
- 5R01DA015075-03
- Conditions
- Youths At-risk for Drug Use/Abuse
- Keywords
- drug prevention, adolescence, middle school, randomized trial, family therapy, cognitive-behavioral, efficacy, selected youth
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Johns Hopkins University
- Study start
- Jan 2005
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this R01 study, a randomized clinical trial is proposed to evaluate the efficacy of a drug abuse prevention intervention for indicated middle school youth that coordinates family and teen-based components. The Family Management Intervention is comprised of a parent-focused curriculum to foster parenting skills followed by brief family therapy to foster adaptive family communication and age-appropriate roles. The Teen Achievement Intervention is comprised of a clinician-delivered learning strategy curriculum to foster academic achievement followed by a similar yet peer-facilitated curriculum to foster self-efficacy and prosocial peer networks. In the first study aim, we seek to evaluate the separate and possibly synergistic effects of the Family Management and Teen Achievement components on post intervention drug use, problem behavior, psychological distress, and academic achievement of indicated youth. Innovative analytic strategies are subsequently used to elucidate mediated pathways by which the interventions might reduce drug involvement and problem behavior by promoting changes in targeted skills and behavior change processes. The possibility of effect-modification also is considered, with a focus on neurocognitive, internalizing/externalizing, and demographic factors, in an effort to discern why interventions work for some youth but not others. This application revision has sought to address well-taken concerns cited by the reviewers while maintaining proposal strengths. In response to a key limitation, this revision includes further specification of anticipated relationships between neurocognitive variables, skill acquisition levels, and prevention intervention outcomes among indicated youth. Study hypotheses on specific neurocognitive effects are informed by empirical findings and the clinical experience of investigative team members specializing in neuropsychology. If successful, this project should improve prevention practices by identifying malleable behavior change processes fostered by effective interventions. Improving our understanding of how individual characteristics of indicated youth, such as neurocognitive deficits or externalizing problems, influence the development of skills during interventions and subsequent outcomes may also help to improve existing prevention interventions. The significance of the proposed study is underscored further by the substantial size of the targeted population of indicated youth, and the range of morbidities and mortality that often result when early warning signs of drug abuse are not addressed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation | Active comparator | Other: PsychoeducationDrug education curriculum was delivered to participants assigned to this condition. |
| Conitive Behavorial Therapy | Experimental | Behavioral: Integrated Family and Cognitive-Behavioral Drug Prevention InterventionThe cognitive-behavioral program introduces youths to problem-solving behavior change principles and study skills to promote school achievement. |
| Family Therapy | Experimental | Behavioral: Integrated Family and Cognitive-Behavioral Drug Prevention InterventionParticipants 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. |
| Intergrated Family and Cognitve Behavioral Therapy | Experimental | Behavioral: Integrated Family and Cognitive-Behavioral Drug Prevention InterventionParticipants assigned to the IFCBT arm received the Cognitive Behavioral Therapy and Family Therapy intervention components. |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 11 to 15 year old middle school students
Key exclusion criteria (2 listed)
- Acute suicidal, homicidal, psychotic ideation
- Problem severity indicating outpatient or residential treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Family and Cognitive-Behavioral Drug Prevention InterventionThe 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. | Behavioural | Conitive Behavorial Therapy, Family Therapy, Intergrated Family and Cognitve Behavioral Therapy |
| PsychoeducationDrug education curriculum was delivered to participants assigned to this condition. | Other | Psychoeducation |
Primary outcome
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.
4 secondary outcomes
Academic achievement
Time frame: 3,6,9,12, and 18 month assessment
Family functioning
Time frame: 3,6,9,12, and 18 month follow-up assessment
Learning Strategy Skill
Time frame: 3,6,9,12, and 18 month assessment
Legal Involvement
Time frame: 3,6,9, 12, and 18 month follow-up assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2012.
- Background: PubMed 12957348Latimer 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William W. Latimer, PhD, MPH principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Integrated Family and Cognitive-Behavioral Drug Prevention Intervention and Psychoeducation in people with Youths At-risk for Drug Use/Abuse, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol use abstinence and frequency (time frame: 3, 6, 9, 12, and 18 month Follow-up assement). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00198939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2012.