Clinical trial NCT00198939: Neurological Influences on Drug Prevention Intervention
Official title: Neurological Influences on Drug Prevention Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Youths At-risk for Drug Use/Abuse
Keywords: drug prevention
adolescence
middle school
randomized trial
family therapy
cognitive-behavioral
efficacy
selected youth
indicated youth
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Johns Hopkins University
First posted: 2005-09-20
Enrollment: 330
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 11 to 15 year old middle school students

Exclusion Criteria:

* Acute suicidal, homicidal, psychotic ideation
* Problem severity indicating outpatient or residential treatment

Primary outcomes:
measure: Alcohol use abstinence and frequency
timeFrame: 3, 6, 9, 12, and 18 month Follow-up assement
measure: Marijuana use abstinence and frequency
timeFrame: 3, 6, 9, 12, and 18 Month Follow-up Assessment
measure: Other drug use abstinence and frequency
timeFrame: 3, 6, 9, 12, 18 month Follow-up Assessment
Secondary outcomes:
measure: Academic achievement
timeFrame: 3,6,9,12, and 18 month assessment
measure: Family functioning
timeFrame: 3,6,9,12, and 18 month follow-up assessment
measure: Learning Strategy Skill
timeFrame: 3,6,9,12, and 18 month assessment
measure: Legal Involvement
timeFrame: 3,6,9, 12, and 18 month follow-up assessment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: William W. Latimer, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.