Family Listening Program: Multi-Tribal Implementation and Evaluation
1 other identifier
interventional
266
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 3, 2017
CompletedFirst Posted
Study publicly available on registry
May 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2019
CompletedResults Posted
Study results publicly available
February 3, 2025
CompletedFebruary 3, 2025
January 1, 2025
5 years
May 3, 2017
March 6, 2024
January 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Child Well-being
Self-report measures of anxiety, Anxiety Panic/GAD Sub-Scale, average change from baseline (pre-program participation). Anxiety Items coded are coded 1-4. The scale was calculated as the arithmetic average of items, which results in a minimum value of 1 and a maximum value of 4. Lower scores are better. The Panic/GAD sub-scale was the average of three items with the same min/max as the full scale. Children surveyed at pre-test, post-test (2-4 months after intervention), and one-year post intervention.
post-test (2-4 months after intervention)
Secondary Outcomes (1)
Child Well-being
Post-post survey: One year after the intervention
Study Arms (2)
Program group
EXPERIMENTALTribal 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.
Comparison group
NO INTERVENTIONUpon 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.
Interventions
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Pueblo of Jemez Department of Education
Jemez Pueblo, New Mexico, 87024, United States
Mescalero Prevention Program
Mescalero, New Mexico, 88340, United States
Ramah Navajo School Board
Pinehill, New Mexico, 87357, United States
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BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Because of the small number of potential participants in each community, we were not able to analyze statistically changes within each community. Aggregate data analysis however was facilitated because of our long-term partnerships with our tribal research teams in each community.
Results Point of Contact
- Title
- Dr. Nina Wallerstein
- Organization
- University of New Mexico College of Population Health
Study Officials
- PRINCIPAL INVESTIGATOR
Lorenda Belone, PhD
University of New Mexico
- PRINCIPAL INVESTIGATOR
Nina Wallerstein, DrPH
University of New Mexico
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- 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. Only children's data are analyzed.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2017
First Posted
May 5, 2017
Study Start
April 1, 2014
Primary Completion
March 31, 2019
Study Completion
March 31, 2019
Last Updated
February 3, 2025
Results First Posted
February 3, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share