- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00956527
Martial Arts as Early Intervention for Teen Drug Abuse
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).
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Colorado
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Aurora, Colorado, Spojené státy, 80045
- University of Colorado Denver
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Change in substance use
Časové okno: end of trial
|
end of trial
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Change in psychosocial functioning and behavioral problems
Časové okno: end of trial
|
end of trial
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Robert Davies, MD, University of Colorado, Denver
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 05-0681
- R01DA018679 (Grant/smlouva NIH USA)
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