An interventional study of Intergenerational culturally adapted curriculum in Substance Abuse, sponsored by University of New Mexico. Completed at 3 sites in United States. Open to participants aged 8 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by University of New Mexico · Not applicable, Interventional, and Prevention
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.
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.
2,181 studies on the registry are indexed under Substance-Related Disorders; 399 are open to participants now.
This study's enrollment of 266 is above the median of 108 across 1,770 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University of New Mexico is the lead sponsor of 312 studies on the registry; 28 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.
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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. Only children's data are analyzed.
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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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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
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.
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.
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.
Time frame: post-test (2-4 months after intervention)
Child Well-being
Self-report measures of depression, change from baseline at one-year, Depression scale items were coded 1 to 3, and the arithmetic mean of 26 items was used to compute the scale. The scale has a minimum of 1.0 and a maximum of 3.0 with higher values be better, i.e. lower levels of depression.
Time frame: Post-post survey: One year after the intervention
Recruitment of children participants occurred in three tribal communities: Ramah Navajo, Mescalero Apache Tribe, and Pueblo of Jemez. UNM Health Sciences Human Research Protections Office (HRPO) approved recruitment from 2014 for up to 12 families (typically one child and one caregiver) from each tribal community for the full five years of the study, with the official closing of the IRB on Feb 6, 2021. Tribes recruited students from different schools in their communities. Parents not analyzed
| Milestone | Program Group | Comparison Group |
|---|---|---|
| Started | 138 | 128 |
| Completed | 93 | 98 |
| Not completed | 45 | 30 |
| Withdrew: Lost to follow-up | 45 | 30 |
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.
| units on a scale | Program Group | Comparison Group |
|---|---|---|
| Child Well-being | -0.20 (-0.34 to -0.05) | 0.05 (-0.10 to 0.20) |
Self-report measures of depression, change from baseline at one-year, Depression scale items were coded 1 to 3, and the arithmetic mean of 26 items was used to compute the scale. The scale has a minimum of 1.0 and a maximum of 3.0 with higher values be better, i.e. lower levels of depression.
| change in units on scale | Program Group | Comparison Group |
|---|---|---|
| Child Well-being | 0.06 (0.01 to 0.11) | -0.01 (-0.07 to 0.05) |
Collected over 2014-2019. This was a five-year study. with each child participant followed over one year, and during this one-year time frame, there were no adverse events in any of the communities. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Program and Comparison Groups | 0/266 (0%) | 0/266 (0%) | 0/266 (0%) |
No difference from assignment in participant flow
| Age, Continuous(years) | Program Group | Comparison Group | Total |
|---|---|---|---|
| Mean | 10 (8 to 12) | 10 (9 to 12) | 10 (8 to 12) |
| Sex: Female, Male(Participants) | Program Group | Comparison Group | Total |
|---|---|---|---|
| Female | 71 | 69 | 140 |
| Male | 67 | 59 | 126 |
| Race/Ethnicity, Customized(Participants) | Program Group | Comparison Group | Total |
|---|---|---|---|
| Tribal members | 138 | 128 | 266 |
| Region of Enrollment(participants) | Program Group | Comparison Group | Total |
|---|---|---|---|
| United States | 138 | 128 | 266 |
| Depression(units on a scale) | Program Group | Comparison Group | Total |
|---|---|---|---|
| Mean | 2.63 ± 0.25 | 2.71 ± 0.23 | 2.67 ± 0.24 |
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