NCT03142009

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

February 3, 2025

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

5 years

First QC Date

May 3, 2017

Results QC Date

March 6, 2024

Last Update Submit

January 28, 2025

Conditions

Keywords

Community-Based Participatory Research

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

EXPERIMENTAL

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

Comparison group

NO INTERVENTION

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.

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.

Program group

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Location

Mescalero Prevention Program

Mescalero, New Mexico, 88340, United States

Location

Ramah Navajo School Board

Pinehill, New Mexico, 87357, United States

Location

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MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

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

  • Lorenda Belone, PhD

    University of New Mexico

    PRINCIPAL INVESTIGATOR
  • Nina Wallerstein, DrPH

    University of New Mexico

    PRINCIPAL INVESTIGATOR

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
Model Details: 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.
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

Locations