Martial Arts as Early Intervention for Teen Drug Abuse

Substance Use Clinical Trial

Official title:

Martial Arts as Early Intervention for Teen Drug Abuse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00956527
• Other study ID #: 05-0681
• Secondary ID: R01DA018679
• Status: Completed
• Phase: N/A
• First received: August 10, 2009
• Last updated: June 18, 2013
• Start date: May 2006
• Est. completion date: October 2009

Study information

• Verified date: June 2013
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adolescent
• Substance Use

Intervention

Behavioral:
• Modified traditional martial arts training
Twice weekly hour-long training sessions. Classes will not vary significantly from those classes already taught at the karate school, with the following exceptions: 1) the focus of training will be primarily on the non-combative components of martial arts training, 2) there will be a higher instructor to student ratio, 3) belt advancement will be based not only on mastery of karate techniques, but also on achieving the predetermined goals as described above, and 4) weekly 5-10 minute talks will be delivered by the primary instructor and will consist of concepts relevant to substance abuse treatment (including both issues directly relating to drug use and the common skills deficits seen in "at risk" youth) and how these issues relate to martial arts concepts.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in substance use		end of trial	No
Secondary	Change in psychosocial functioning and behavioral problems		end of trial	No