- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03142009
Familielyttingsprogram: Implementering og evaluering av flere stammer
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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New Mexico
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Jemez Pueblo, New Mexico, Forente stater, 87024
- Pueblo of Jemez Department of Education
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Mescalero, New Mexico, Forente stater, 88340
- Mescalero Prevention Program
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Pinehill, New Mexico, Forente stater, 87357
- Ramah Navajo School Board
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Beskrivelse
Inkluderingskriterier: Inkluderingskriterier inkluderer alle familier fra Mescalero Apache, Jemez Pueblo og Ramah Navajo med et barn i fjerde og femte klasse og deres foreldre eller foresatte, og besteforeldre som vil melde seg frivillig til å delta.
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Eksklusjonskriterier: De som ikke er kvalifisert i denne studien er: de som ikke gir samtykke og/eller samtykke til å delta; de som ikke identifiserer seg som stammemedlemmer av Mescalero Apache, Jemez Pueblo og Ramah Navajo eller som familiemedlem til noen som identifiserer seg som Mescalero Apache, Jemez Pueblo og Ramah Navajo; barn og som ikke er i målområdet til fjerde og femte klasse.
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Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Programgruppe
Medlemmer av Tribal Research Team rekrutterer deltakere ved å sende brev hjem med barna i fjerde og femte klasse.
Dette brevet gir en oversikt over FL/CP og inviterer interesserte foreldre og barn til å lære mer.
TRT- og UNM-teammedlemmer følger opp med interesserte foreldre individuelt.
Hvis familier er forpliktet til å være en del av FL/CP, er det satt opp et møte for å gjennomføre den informerte samtykkeprosessen og fullføre forhåndstesten.
Familier i programgruppen deltar deretter på FL/CP-økter som dekker den intergenerasjonelle kulturtilpassede læreplanen.
Programfamilier deltar også i ulike aspekter av programmet, inkludert å fullføre et Community Action Project.
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Hver økt starter med en kollektiv middag med familier som spiser sammen.
Så øv på deres indiske navn og klannavn.
Øktene ledes av tilretteleggere på deres eget språk eller tospråklig.
Tilretteleggerne deler deretter familiene inn i barne- og voksengrupper for å ta opp temaet for økten, og de kommer deretter tilbake sammen på slutten av økten for å dele læringen sin.
Øktene avsluttes alltid med at barna og de voksne skriver i journalene sine som er enkeltsider som de så legger i pensumpermene sine.
Familier får deretter "hjemmepraksis", som er en oppgave som familiene gjør sammen i løpet av den mellomliggende uken.
Tilretteleggerne samler inn pensumpermene etter hver økt for å bringe tilbake til familiene neste uke.
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Ingen inngripen: Sammenligningsgruppe
Etter å ha mottatt brevet vil familier som valgte å ikke delta eller som takker nei til å delta, bli invitert til å delta i forskningsstudien som sammenligningsdeltakere.
Sammenligningsdeltakere deltar ikke på FL/CP-øktene og fullfører kun pre-, post- og 1-års post-testene.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Rusmisbruk av barn
Tidsramme: Langsgående over 4 år
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Selvrapportering av bruk av alkohol, tobakk eller andre rusmidler
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Langsgående over 4 år
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Barns trivsel
Tidsramme: Langsgående over 4 år
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Selvrapporteringsmål for depresjon, angst, empati, problemløsning, familietilfredshet, tradisjonelle aktiviteter og kultur
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Langsgående over 4 år
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Familiens velvære
Tidsramme: Langsgående over 4 år
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Selvrapporteringstiltak for sosial støtte, mestringsstrategier, foreldreferdigheter, tradisjonelle aktiviteter og kultur
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Langsgående over 4 år
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Lorenda Belone, PhD, University of New Mexico
- Hovedetterforsker: Nina Wallerstein, DrPH, University of New Mexico
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
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- Beauvais F. An integrated model for prevention and treatment of drug abuse among American Indian youth. J Addict Dis. 1992;11(3):63-80. doi: 10.1300/J069v11n03_04.
- Mail PD, Johnson S. Boozing, sniffing, and toking: an overview of the past, present, and future of substance use by American Indians. Am Indian Alsk Nativ Ment Health Res (1987). 1993;5(2):1-33. doi: 10.5820/aian.0502.1993.1.
- Beauvais F. Preventing Drug Abuse among Native American Young People. 1980, Fort Collins, CO: Western Behavioral Studies.
- Beauvais F. Preventing Drug Abuse among Native American Young People. 1996, Ft. Collins, CO: Western Behavioral Studies
- Okwumabua JO, Duryea EJ. Age of onset, periods of risk, and patterns of progression in drug use among American Indian high school students. Int J Addict. 1987 Dec;22(12):1269-76. doi: 10.3109/10826088709027486.
- Swaim RC, Oetting ER, Edwards RW, Beauvais F. Links from emotional distress to adolescent drug use: a path model. J Consult Clin Psychol. 1989 Apr;57(2):227-31. doi: 10.1037//0022-006x.57.2.227.
- NMDOH, Racial and ethnic health disparities report card, O.o.P.a.M. Health, Editor, 2007, NMDOH: Department of Health Santa Fe, NM. p. 1-24.
- Szlemko WJ, Wood JW, Thurman PJ. Native Americans and alcohol: past, present, and future. J Gen Psychol. 2006 Oct;133(4):435-51. doi: 10.3200/GENP.133.4.435-451.
- Miller WR. Motivational interviewing: research, practice, and puzzles. Addict Behav. 1996 Nov-Dec;21(6):835-42. doi: 10.1016/0306-4603(96)00044-5.
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- United States Census, B., 2010 Census Interactive Population Search: New Mexico, 2010.
- Racial and Ethnic Health Disparities Report Card, 7th Edition, N.M.D.o. Health, Editor 2012, Office of Health Equity, Office of Policy and Accountability: Santa Fe, NM. p. 1-43.
- New Mexico Youth Risk and Resiliency Survey (YRRS): American Indian High School Students - Aggregate Report, 2009, New Mexico Department of Health, New Mexico Public Education Department, University of New Mexico Prevention Research Center, Albuquerque Area Southwest Tribal Epidemiology Center. p. 1-197.
- Oetting ER, Swaim RC, Edwards RW, Beauvais F. Indian and Anglo adolescent alcohol use and emotional distress: path models. Am J Drug Alcohol Abuse. 1989;15(2):153-72. doi: 10.3109/00952998909092718.
- Conger RD, Lorenz FO, Elder GH, Melby JN, Simons RL, Conger KJ. A process model of family economic pressure and early adolescent alcohol use. The Journal of Early Adolescence 11(4): 430, 1991
- Loeber, R. Antisocial behavior and mental health problems explanatory factors in childhood and adolescence. 1998; Available from: http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=19368.
- Gottesman IL, Goldsmith HH. Developmental Psychology of Antisocial Behaviors: Interting Genes into its Ontogenesis and Epigenesis, in Threats to Optimal Development: Integrating Biological, Psychological and Social Risk Factors, C.A. Nelson, Editor. 1994
- Lahey BB, Piacentini JC, McBurnett K, Stone P, Hartdagen S, Hynd G. Psychopathology in the parents of children with conduct disorder and hyperactivity. J Am Acad Child Adolesc Psychiatry. 1988 Mar;27(2):163-70. doi: 10.1097/00004583-198803000-00005. No abstract available. Erratum In: J Am Acad Child Adolesc Psychiatry 1988 Jul;27(4):516.
- O'Connor TG, McGuire S, Reiss D, Hetherington EM, Plomin R. Co-occurrence of depressive symptoms and antisocial behavior in adolescence: a common genetic liability. J Abnorm Psychol. 1998 Feb;107(1):27-37. doi: 10.1037//0021-843x.107.1.27.
- Silberg J, Rutter M, Meyer J, Maes H, Hewitt J, Simonoff E, Pickles A, Loeber R, Eaves L. Genetic and environmental influences on the covariation between hyperactivity and conduct disturbance in juvenile twins. J Child Psychol Psychiatry. 1996 Oct;37(7):803-16. doi: 10.1111/j.1469-7610.1996.tb01476.x.
- Duran B. Duran E, Braveheart MYH. Native Americans and the trauma of history, in Studying Native America: Problems and Prospects in Native American Studies, R. Thornton, Editor. 1998, University of Wisconsin Press: Madison.
- Duran E, Duran B. Native American postcolonial psychology. 1995, Albany, NY US: State University of New York Press.
- Duncan TE, Tildesley E, Duncan SC, Hops H. The consistency of family and peer influences on the development of substance use in adolescence. Addiction. 1995 Dec;90(12):1647-60. doi: 10.1046/j.1360-0443.1995.901216477.x.
- Dinges MM, Oetting ER. Similarity in drug use patterns between adolescents and their friends. Adolescence. 1993 Summer;28(110):253-66.
- Hawkins EH, Cummins LH, Marlatt GA. Preventing substance abuse in American Indian and Alaska native youth: promising strategies for healthier communities. Psychol Bull. 2004 Mar;130(2):304-23. doi: 10.1037/0033-2909.130.2.304.
- Kandel DB, Yamaguchi K, Chen K. Stages of progression in drug involvement from adolescence to adulthood: further evidence for the gateway theory. J Stud Alcohol. 1992 Sep;53(5):447-57. doi: 10.15288/jsa.1992.53.447.
- Rutter M. Psychosocial resilience and protective mechanisms. Am J Orthopsychiatry. 1987 Jul;57(3):316-331. doi: 10.1111/j.1939-0025.1987.tb03541.x.
- Catalano RF, Berglund ML, Ryan JAM, Lonczak HS, Hawkins JD. Positive Youth Development in the United States: Research Findings on Evalutions of Positive Youth Development Programs. Annals of the American Academy of Political and Social Science, 2004. 591(1): p. 98.
- Kumpfer KL, Molgaard V, Spoth R. The Strengthening Families Program for the prevention of delinquency and drug use, R.D. Peters and R.J. McMahon, Editors. 1996, Sage Publications Inc: Thousand Oaks, CA US. p. 241.
- Brody GH, Chen YF, Kogan SM, Yu T, Molgaard VK, DiClemente RJ, Wingood GM. Family-centered program deters substance use, conduct problems, and depressive symptoms in black adolescents. Pediatrics. 2012 Jan;129(1):108-15. doi: 10.1542/peds.2011-0623. Epub 2011 Dec 12.
- Whitbeck LB, Hoyt Dr, Stubben JD, LaFromboise T. Traditional culture and academic success among American Indian children in the upper Midwest. Journal of American Indian Education 40(2): 48, 2001
- Dumont M, Provost MA. Resilience in adolescents: Protective role of social support, coping strategies, self-esteem, and social activities on experience of stress and depression. Journal of Youth and Adolescence 28(3): 343, 1999
- Whitbeck LB, McMorris BJ, Hoyt DR, Stubben JD, Lafromboise T. Perceived discrimination, traditional practices, and depressive symptoms among American Indians in the upper midwest. J Health Soc Behav. 2002 Dec;43(4):400-18.
- Whitbeck LB, Hoyt DR, McMorris BJ, Chen X, Stubben JD. Perceived discrimination and early substance abuse among American Indian children. J Health Soc Behav. 2001 Dec;42(4):405-24.
- Coggins K, Williams E, Radin N. The Traditional Values of the Ojibwe Parents and the School Performance of their Children: An Exploratory Study. Journal of American Indian Education 36(3): 1, 1997
- Pankratz MM, Jackson-Newsom J, Giles SM, Ringwalt CL, Bliss K, Bell ML. Implementation fidelity in a teacher-led alcohol use prevention curriculum. J Drug Educ. 2006;36(4):317-33. doi: 10.2190/H210-2N47-5X5T-21U4.
- Cajete G. Look to the Mountain: An Ecology of Indigenous Education. First Edition. 1994: Kivaki Press 585 E. 31st St. Durango CO 81301
- Wallerstein, N., Evidence of effectiveness of empowerment interventions to reduce health disparities and social exclusion. Health Evidence Network, 2006.
- Altman DG, Feighery EC. Future directions for youth empowerment: commentary on application of youth empowerment theory to tobacco control. Health Educ Behav. 2004 Oct;31(5):641-7. doi: 10.1177/1090198104268683. No abstract available.
- Holden DJ, Messeri P, Evans WD, Crankshaw E, Ben-Davies M. Conceptualizing youth empowerment within tobacco control. Health Educ Behav. 2004 Oct;31(5):548-63. doi: 10.1177/1090198104268545.
- Berg M, Coman E, Schensul JJ. Youth Action Research for Prevention: a multi-level intervention designed to increase efficacy and empowerment among urban youth. Am J Community Psychol. 2009 Jun;43(3-4):345-59. doi: 10.1007/s10464-009-9231-2.
- Lipari L. Listening, Thinking, Being. Communication Theory. 20(3): 348, 2010
- Wallerstein N, Auerbach E. Problem-posing at work: Popular educator's guide. 2004: Grass Roots Press.
- Pueblo of Jemez. [cited 2013 April 27]; Available from: http://www.jemezpueblo.org/.
- Wallerstein N, Duran BM, Aguilar J, Joe L, Loretto F, Toya A, Yepa-Waquie H, Padilla R, Shendo K. Jemez Pueblo: built and social-cultural environments and health within a rural American Indian community in the Southwest. Am J Public Health. 2003 Sep;93(9):1517-8. doi: 10.2105/ajph.93.9.1517. No abstract available.
- English KC, Wallerstein N, Chino M, Finster CE, Rafelito A, Adeky S, Kennedy M. Intermediate outcomes of a tribal community public health infrastructure assessment. Ethn Dis. 2004 Summer;14(3 Suppl 1):S61-9.
- Cashman SB, Adeky S, Allen AJ 3rd, Corburn J, Israel BA, Montano J, Rafelito A, Rhodes SD, Swanston S, Wallerstein N, Eng E. The power and the promise: working with communities to analyze data, interpret findings, and get to outcomes. Am J Public Health. 2008 Aug;98(8):1407-17. doi: 10.2105/AJPH.2007.113571. Epub 2008 Jun 12.
- Oetzel J, Wallerstein N, Solimon A, Garcia B, Siemon M, Adeky S, Apachito G, Caston E, Finster C, Belone L, Tafoya G. Creating an instrument to measure people's perception of community capacity in American Indian communities. Health Educ Behav. 2011 Jun;38(3):301-10. doi: 10.1177/1090198110379571. Epub 2011 Apr 5.
- Spoth R, Redmond C. Illustrating a Framework for Rural Prevention Research: Project Family Studies of Rural Families Participation and Outcomes, in Preventing Childhood Disorders, Substance Abuse, and Delinquency, R.D. Petters and R.J. McMahon, Editors. 1996, Sage Publications: Thousand Oaks, CA.
- Spoth R, Redmond C, Haggerty K, Ward T. A Controlled Parenting Skills Outcome Study Examining Individual Difference and Attendance Effects. Journal of Marriage & Family 57(2): 449, 1995.
- Whitbeck, L.B., Bii-zin-da-de-da: The listening to one another prevention program. Workshop presented at the Second National Conference on Drug Abuse Prevention Research: A Progress Update, Washington, DC, 2001.
- Dutta A. Development-induced displacement and human rights. 2007, New Dilhi: Deep & Deep Publications.
- Hall GC. Psychotherapy research with ethnic minorities: empirical, ethical, and conceptual issues. J Consult Clin Psychol. 2001 Jun;69(3):502-10. doi: 10.1037//0022-006x.69.3.502.
- Hawe P, Shiell A, Riley T. Theorising interventions as events in systems. Am J Community Psychol. 2009 Jun;43(3-4):267-76. doi: 10.1007/s10464-009-9229-9.
- Wang CC. Youth participation in photovoice as a strategy for community change. Journal of Community Practice 14(1): 147, 2006
- Dutta MJ. Communicating about culture and health: Theorizing culture-centered and cultural sensitivity approaches. Communication Theory 17(3): 304, 2007
- World Health, O. Committee on Indigenous Health. (1999, 2007). The Geneva Declaration on the Health and Survival of Indigenous Peoples (WHO/HSD/00.1.). United Nations Declaration on the Rights of Indigenous Peoples, adopted by General Assembly, 2007 (A/RES/61/295). [cited 2011 01/17]; Available from: http://www.un.org/esa/socdev/unpfii/en/declaration.html.
- Belone L. et al/ Using participatory research to address substance use in an American-Indian community, in Communication Activism: Struggling for social justice amidst difference, L.R. Frey and K.M. Carragee, Editors. Hampton Press, Inc.: New York, NY. p. 403-434, 2012
- Israel BA, Schulz AJ, Parker EA, Becker AB. Review of community-based research: assessing partnership approaches to improve public health. Annu Rev Public Health. 1998;19:173-202. doi: 10.1146/annurev.publhealth.19.1.173.
- Israel BA., et al., eds. Methods In CBPR for Health. 2nd ed. Jossy-Bass: San Francisco, 2012
- Walters KL, et al., 'Indigenist' collaborative research efforts in Native American communities, A.R. Stiffman, Editor. Oxford University Press: New York, NY US. p. 146, 2009
- Laveaux D, Christopher S. Contextualizing CBPR: Key Principles of CBPR meet the Indigenous research context. Pimatisiwin. 2009 Jun 1;7(1):1.
- Minkler M, Wallerstein N. Community-Based Participatory Research for Health: From Process to Outcomes. 2nd ed. Jossey-Bass: San Francisco, 2008
- Brownson RC, Colditz GA, Proctor EK. Dissemination and implementation research in health : translating science to practice. 2012: Oxford ; New York : Oxford University Press 2012.
- Cook TD, Campbell DT. Quasi-Experimentation: Design & Analysis Issues for Field Settings. Boston: Houghton-Mifflin, 1979.
- Buchanan DR, Miller FG, Wallerstein N. Ethical issues in community-based participatory research: balancing rigorous research with community participation in community intervention studies. Prog Community Health Partnersh. 2007 Summer;1(2):153-60. doi: 10.1353/cpr.2007.0006.
- Hicks S, Duran B, Wallerstein N, Avila M, Belone L, Lucero J, Magarati M, Mainer E, Martin D, Muhammad M, Oetzel J, Pearson C, Sahota P, Simonds V, Sussman A, Tafoya G, Hat EW. Evaluating community-based participatory research to improve community-partnered science and community health. Prog Community Health Partnersh. 2012 Fall;6(3):289-99. doi: 10.1353/cpr.2012.0049.
- Pearson C., et al., CBPR Variable Matrix: Research for Improved Health in Academic-Community Partnerships.CES4Health.info. 2011.
- Garcia LF, Aluja A, Del Barrio V. Testing the hierarchical structure of the Children's Depression Inventory: a multigroup analysis. Assessment. 2008 Jun;15(2):153-64. doi: 10.1177/1073191107310310.
- Greenspoon PJ, Saklofske DH. Validity and reliability of the multidimensional student's life satisfaction scale with Canadian children. Journal of psychoeducational assessment 15: 138-155, 1997.
- Hanson TL, Kim JO. Measuring resilience and youth development: the psychometric properties of the health Kids Survey. Wahington, DC: U.S. Department of Education, Institute of Education Sciences, National Center for Education Evaluation and Regional Assistance, Regional Educational Laboratory West Retrieved from http://ies.ed.gov/ncee/edlabs. 2007
- Kovacs M. Children's Depression Inventory. New York, NY: Multi-Health Systems, 1992.
- March JS, Parker JD, Sullivan K, Stallings P, Conners CK. The Multidimensional Anxiety Scale for Children (MASC): factor structure, reliability, and validity. J Am Acad Child Adolesc Psychiatry. 1997 Apr;36(4):554-65. doi: 10.1097/00004583-199704000-00019.
- Orvaschel H, Weissman MM, Padian N, Lowe TL. Assessing psychopathology in children of psychiatrically disturbed parents: A pilot study. J Am Acad Child Psychiatry. 1981 Winter;20(1):112-22. doi: 10.1016/s0002-7138(09)60721-4. No abstract available.
- Weissman MM, Orvaschel H, Padian N. Children's symptom and social functioning self-report scales. Comparison of mothers' and children's reports. J Nerv Ment Dis. 1980 Dec;168(12):736-40. doi: 10.1097/00005053-198012000-00005.
- Wilson N, Minkler M, Dasho S, Wallerstein N, Martin AC. Getting to social action: the Youth Empowerment Strategies (YES!) project. Health Promot Pract. 2008 Oct;9(4):395-403. doi: 10.1177/1524839906289072. Epub 2006 Jun 27.
- Zimmerman, M. Empowerment Theory: Psychological, Organizational and Community Levels of Analysis. In J. Rappaport (Ed.), Handbook of Community Psychology. New York: Kluwer Academic/Plenum Publishing, 2000.
- Zimmerman MA, Ramirez-Valles J, Washienko KM, Walter B, Dyer S. The development of a measure of enculturation for Native American youth. Am J Community Psychol. 1996 Apr;24(2):295-310. doi: 10.1007/BF02510403.
- Belone L, Tosa J, Shendo K, Toya A, Straits K, Tafoya G, Rae R, Noyes E, Bird D, Wallerstein N. Community Based Participatory Research for Cocreating interventions with Native communities: a partnership between the University of New Mexico and The Pueblo of Jemez. In Zane N, Bernal G, Leong FTL, ed. Evidence Based Psychological Practices With Ethnic Minorities. American Psychological Association (APA); 2016: 199-220.
- Belone L, Oetzel JG, Wallerstein N, Tafoya G, Rae R, Rafelito A, Kelhoyouma L, Burbank I, Finster C, Henio-Charley J, Maria PG, Thomas A. Using participatory research to address substance use in an American-Indian community. In Frey LR, Carragee KM, ed. Communication Activism: Struggling for social justice amidst difference. New York, NY: Hampton Press, Inc; 2012: 403-434.
- Conger RD. The social context of substance abuse: a developmental perspective. NIDA Res Monogr. 1997;168:6-36. No abstract available.
- Shendo K, Toya A, Tafoya E, Yepa M, Tosa J, Yepa T, Yepa-Waquie H, Gachupin D, Gachupin C, Yepa K, Rae R, Belone L, Tafoya G, Noyes E, Wallerstein N. An Intergenerational Family Community-Based Participatory Research Prevention Program: Hemish of Walatowa Family Circle Program. IHS Prim Care Provid. 2012 Aug;37(8):185-191. No abstract available.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 14-289
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