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Family Listening Program: Multi-Tribal Implementation and Evaluation

Primary Purpose

Substance Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intergenerational culturally adapted curriculum
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Abuse focused on measuring Community-Based Participatory Research

Eligibility Criteria

8 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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.

-

Sites / Locations

  • Pueblo of Jemez Department of Education
  • Mescalero Prevention Program
  • Ramah Navajo School Board

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Program group

Comparison group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Child substance abuse
Self-report measures of alcohol, tobacco, or other drug use

Secondary Outcome Measures

Child well-being
Self-report measures of depression, anxiety, empathy, problem solving, family satisfaction, traditional activities & culture
Family well-being
Self-report measures of social support, coping strategies, parenting-skills, traditional activities & culture

Full Information

First Posted
May 3, 2017
Last Updated
May 24, 2023
Sponsor
University of New Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT03142009
Brief Title
Family Listening Program: Multi-Tribal Implementation and Evaluation
Official Title
Family Listening Program: Multi-Tribal Implementation and Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
February 6, 2021 (Actual)
Study Completion Date
February 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of New Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
Community-Based Participatory Research

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Allocation
Non-Randomized
Enrollment
576 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Program group
Arm Type
Experimental
Arm Description
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.
Arm Title
Comparison group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intergenerational culturally adapted curriculum
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child substance abuse
Description
Self-report measures of alcohol, tobacco, or other drug use
Time Frame
Longitudinal over 4 years
Secondary Outcome Measure Information:
Title
Child well-being
Description
Self-report measures of depression, anxiety, empathy, problem solving, family satisfaction, traditional activities & culture
Time Frame
Longitudinal over 4 years
Title
Family well-being
Description
Self-report measures of social support, coping strategies, parenting-skills, traditional activities & culture
Time Frame
Longitudinal over 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenda Belone, PhD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nina Wallerstein, DrPH
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pueblo of Jemez Department of Education
City
Jemez Pueblo
State/Province
New Mexico
ZIP/Postal Code
87024
Country
United States
Facility Name
Mescalero Prevention Program
City
Mescalero
State/Province
New Mexico
ZIP/Postal Code
88340
Country
United States
Facility Name
Ramah Navajo School Board
City
Pinehill
State/Province
New Mexico
ZIP/Postal Code
87357
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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