Family Listening Program: Multi-Tribal Implementation and Evaluation

• ClinicalTrials.gov Identifier: NCT03142009
• Recruitment Status: Unknown
• First Posted: May 5, 2017
• Last Update Posted: May 8, 2017
• Sponsor: University of New Mexico
• Information provided by (Responsible Party): University of New Mexico

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Substance Abuse	Other: Intergenerational culturally adapted curriculum	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 576 participants
• 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
• Actual Study Start Date: April 1, 2014
• Estimated Primary Completion Date: April 2018
• Estimated Study Completion Date: March 31, 2019

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Child well-being [ Time Frame: Longitudinal over 4 years ]
   Self-report measures of depression, anxiety, empathy, problem solving, family satisfaction, traditional activities & culture
2. Family well-being [ Time Frame: Longitudinal over 4 years ]
   Self-report measures of social support, coping strategies, parenting-skills, traditional activities & culture

Eligibility Criteria

• 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.

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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.

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Contacts and Locations

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

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• Responsible Party: University of New Mexico
• ClinicalTrials.gov Identifier: NCT03142009
• Other Study ID Numbers: 14-289
• 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