Clinical trial NCT00956527: Martial Arts as Early Intervention for Teen Drug Abuse
Official title: Martial Arts as Early Intervention for Teen Drug Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent
Substance Use
Keywords: Adolescent
Substance Use
Early Intervention
Martial Arts
Karate
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-08-11
Enrollment: 31
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Stage 1A/1B behavioral therapy development project with the aim of developing and piloting an early intervention based upon traditional martial arts for adolescents who are in the early stages of substance use/misuse.

The primary aims of this study are:

1) To develop a manualized version of an existing, typical traditional martial arts program, modified to target a reduction in substance use and the associated behavioral and psychosocial problems for adolescents in the early stages of substance use or misuse, based on principles derived from empirically-based prevention programs. 2) To obtain preliminary pilot data on recruitment feasibility, validity of assessments, and estimates of the effect size of the intervention in reducing substance use and improving prosocial behavioral and psychosocial outcomes. 3) To refine and further develop the manualized program based on pilot data and utilizing feedback from the initial cohort of participants, traditional martial arts program instructors and substance abuse treatment experts. The goals of these revisions would be to maximize the impact of the program on substance use and behavioral outcomes, while retaining the core features of a traditional martial arts program to ensure the feasibility of implementing, sustaining, and disseminating such a program in existing community-based martial arts programs. 4) To develop procedures for training interventionists (i.e., martial arts instructors and research assistants) and for monitoring program adherence to ensure fidelity. 5) To conduct a small pilot study of the refined manualized program to enable us to estimate the effect size of the intervention and provide information for estimating power for a larger randomized controlled trial should the results of this intervention prove promising in terms of positive impact on the primary and secondary outcome measures: decreased drug use and improvement in psychosocial functioning and behavioral problems (including aggression).


Eligibility criteria: Inclusion Criteria:

Subjects must: 1) be 13 through 17 years old, 2) be of estimated average intelligence (IQ\>80), 3) have current or recent drug/alcohol use as evidenced by a history of substance use of at least 2 times in the 12 weeks prior to study inclusion, and 4) be medically healthy.

Exclusion Criteria:

Subjects will be excluded if they 1) meet criteria for substance dependence (other than for nicotine) based on consensus between the Composite International Diagnostic Interview- Substance Abuse Model (CIDI-SAM) and clinical interview, 2) have a history of or currently have psychosis (not explained by drug use), or bipolar disorder that is currently unstable, 3) are currently receiving psychotherapy or some form of behavioral therapy, 4) have a chronic medical illness or condition that would keep them from fully participating in physical activity, 5) have been started on a psychotropic medication in the 30 days prior to study inclusion, or 6) are pregnant.

Primary outcomes:
measure: Change in substance use
timeFrame: end of trial
Secondary outcomes:
measure: Change in psychosocial functioning and behavioral problems
timeFrame: end of trial
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Robert Davies, MD
role: PRINCIPAL_INVESTIGATOR
References: