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Family Listening Program: Multi-Tribal Implementation and Evaluation

This study is currently recruiting participants.
Verified May 2017 by University of New Mexico
Sponsor:
ClinicalTrials.gov Identifier:
NCT03142009
First Posted: May 5, 2017
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of New Mexico
  Purpose
This is a five-year R01 effectiveness trial where tribal partners are committed to assessing the Family Listening/Circle Program's effectiveness and disseminating the approach and intervention within Indian Country as a best practice in reducing substance abuse health disparities.Three specific aims of the grant are 1) To rigorously test effectiveness of FLCP; with a comparative longitudinal design within and across the tribes, with 4th graders to prevent substance initiation/use and strengthen families; 2) Through CBPR, support TRTs to transform their research capacities into local prevention research infrastructures and partnering; 3)To assess additional program effects on other health/education programs and leadership within the tribes. In sum, this multi-tribal/academic partnership builds on accomplishments to test the effectiveness of an innovative intervention. This grant provides an unparalleled opportunity to reduce substance abuse in three tribal communities, strengthen tribal research capacities, and impact substance abuse prevention research designs nationally, by illustrating how CBPR processes can integrate evidence-based and cultural-centered practices to create effective programs that generate community ownership and sustainability.

Condition Intervention
Substance Abuse Other: Intergenerational culturally adapted curriculum

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The investigators use a two arm non-equivalent control group design with pretest, immediate post- test, and 12 month follow-up assessment points. Among quasi-experimental designs that could be employed, this design carries several advantages over other designs in being able to infer causality. One advantage of this design is that it allows for a more meaningful analysis of the impact of the FL/CP intervention by a comparison of the intervention group with the usual and customary comparison group, an advantage not possible with single-group over time designs. Second, the design provides an analysis of diffusion effects (i.e. the potential influence of the intervention on the comparison group over time). Given the tight social networks and small number of interconnected families in the three participating communities, the investigators expect some degree of program diffusion in the comparison group families.
Masking: None (Open Label)
Masking Description:
Due to factors that make the randomization of participants to either an intervention or usual and customary treatment group not feasible, the investigators do not use randomization or masking.
Primary Purpose: Prevention
Official Title: Family Listening Program: Multi-Tribal Implementation and Evaluation

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Child substance abuse [ Time Frame: Longitudinal over 4 years ]
    Self-report measures of alcohol, tobacco, or other drug use


Secondary Outcome Measures:
  • Child well-being [ Time Frame: Longitudinal over 4 years ]
    Self-report measures of depression, anxiety, empathy, problem solving, family satisfaction, traditional activities & culture

  • Family well-being [ Time Frame: Longitudinal over 4 years ]
    Self-report measures of social support, coping strategies, parenting-skills, traditional activities & culture


Estimated Enrollment: 576
Actual Study Start Date: April 1, 2014
Estimated Study Completion Date: March 31, 2019
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Program group
Tribal Research Team members recruit participants by sending letters home with the fourth and fifth grade children. This letter provides an overview of the FL/CP and invite interested parents and children to learn more. TRT and UNM team members follow-up with interested parents individually. If families are committed to being a part of FL/CP, a meeting is set to conduct the informed consent process and complete pretest. Families in the program group then attend FL/CP sessions which covers the intergenerational culturally adapted curriculum. Program families also participate in various aspects of the program including completing a Community Action Project.
Other: Intergenerational culturally adapted curriculum
Each session starts with a collective dinner with families eating together. Then practice their Indian and clan names. The sessions are led by facilitators in their own language or bilingually. The facilitators then divide the families into children and adult groups to address the theme of the session, and they then return together at the end of the session to share their learnings. The sessions always end with the children and adults writing in their journals which are individual pages that they then put in their curriculum binders. Families are then given their "home practice," which is a task that the families do together during the intervening week. The facilitators collect the curriculum binders after each session to bring back to the families the next week.
No Intervention: Comparison group
Upon receiving the letter families that selected not to participate or who decline to participate will be invited to take part in the research study as comparison participants. Comparison participants do not attend the FL/CP sessions and only complete the pre, post and 1 year post tests.

Detailed Description:
With substance abuse concerns plaguing tribal communities, health preventive approaches for American Indian (AI) children need urgent attention. Mainstream programs fall short by failing to speak to AI children on their own terms. Not so with the Family Listening/Circle Program (FL/CP) which integrates an evidence-based family-strengthening core, with cultural values and practices for 4th graders, their parents and elders. Through previous Native American Research Centers for Health funding (Indian Health Service & National Institutes of Health partnership) the FL/CP was created and piloted by community-based participatory research (CBPR) partnerships between the University of New Mexico Center for Participatory Research and three tribal communities: Pueblo of Jemez, Ramah Band of Navajo and Mescalero Apache Nation. FL/CP fills a gap in substance abuse prevention by recapturing historic traditions of cultural transmission, such as family dinner story-telling where elders connect with children, supporting enhanced child-family communication and psycho-social coping through traditional dialogue, indigenous languages and empowerment where children and families create community action projects addressing community substance abuse. With initial FL/CP pilot and feasibility research completed, Tribal Research Teams (TRTs) from the Pueblo of Jemez, Ramah Band of Navajo and Mescalero Apache Nation are now in place for full program implementation and effectiveness testing through a longitudinal quasi-experimental design involving a long-term, multi-tribal/academic research partnership. Under this five-year R01 effectiveness trial, tribal partners are committed to assessing the program's effectiveness and disseminating the approach and intervention within Indian Country as a best practice in reducing substance abuse health disparities, with TRTs collaborating on all research activities, implementation, interpretation/analysis, and dissemination plans. Three specific aims are 1) To rigorously test effectiveness of FLCP; with a comparative longitudinal design within and across the tribes, with 4th graders to prevent substance initiation/use and strengthen families; 2) Through CBPR, support TRTs to transform their research capacities into local prevention research infrastructures and partnering; 3)To assess additional program effects on other health/education programs and leadership within the tribes. In sum, this multi-tribal/academic partnership builds on accomplishments to test the effectiveness of an innovative intervention. This grant provides an unparalleled opportunity to reduce substance abuse in three tribal communities, strengthen tribal research capacities, and impact substance abuse prevention research designs nationally, by illustrating how CBPR processes can integrate evidence-based and cultural-centered practices to create effective programs that generate community ownership and sustainability.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Inclusion criteria includes any families from Mescalero Apache, Jemez Pueblo and Ramah Navajo with a fourth and fifth-grade child and their parents or guardian, and grandparents who will volunteer to participate.

Exclusion Criteria:Those whom are ineligible in this study are: those that do not give consent and/or assent to participate; those that do not identify as tribal members of Mescalero Apache, Jemez Pueblo and Ramah Navajo or as the family member of someone that identifies as Mescalero Apache, Jemez Pueblo and Ramah Navajo; children and that are not in the targeted range of fourth and fifth grade.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03142009


Contacts
Contact: Mingma L Sherpa, M.S 505-925-1224 mingma@salud.unm.edu

Locations
United States, New Mexico
Pueblo of Jemez Department of Education Recruiting
Jemez Pueblo, New Mexico, United States, 87024
Contact: Janice Tosa, B.S    575-834-9102    Janice.C.Tosa@jemezpueblo.org   
Mescalero Prevention Program Recruiting
Mescalero, New Mexico, United States, 88340
Contact: Ardena Orosco    575-464-4516    mescprevpg@matisp.net   
Ramah Navajo School Board Recruiting
Pinehill, New Mexico, United States, 87357
Contact: Benelda Cohoe-Belone    505-775-3271 ext 303    benelda.cohoe-belone@ihs.gov   
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Lorenda Belone, PhD University of New Mexico
Principal Investigator: Nina Wallerstein, DrPH University of New Mexico
  More Information

Publications:
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
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.
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.
Conger RD. The Social Context of Substance Abuse: A Developmental Perspective, in Rural Substance Abuse: State of Knowledge and Issues, E.B. Robinson and et al., Editors. 1997, NIDA: Washington, D.C.
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
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.
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.
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
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
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.
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/.
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.
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.
Shendo K., et al., An Intergenerational Family Community-Based Participatory Research Prevention Program: Hemish of Walatowa Family Circle Program, in The IHS Primary Care Provider, I.H.S. Department of Health & Human Services, Editor 185-191, 2012
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., 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
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.
Pearson C., et al., CBPR Variable Matrix: Research for Improved Health in Academic-Community Partnerships.CES4Health.info. 2011.
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.
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.
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.

Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT03142009     History of Changes
Other Study ID Numbers: 14-289
First Submitted: May 3, 2017
First Posted: May 5, 2017
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of New Mexico:
Community-Based Participatory Research

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders