- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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).
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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-
Colorado
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Aurora, Colorado, Stany Zjednoczone, 80045
- University of Colorado Denver
-
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
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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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
Change in substance use
Ramy czasowe: end of trial
|
end of trial
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
Change in psychosocial functioning and behavioral problems
Ramy czasowe: end of trial
|
end of trial
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Robert Davies, MD, University of Colorado, Denver
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 05-0681
- R01DA018679 (Grant/umowa NIH USA)
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