Substance Abuse
Conditions
Keywords
Community-Based Participatory Research
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.
Interventions
OTHERIntergenerational 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.
Sponsors
University of New Mexico
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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. Only children's data are analyzed.
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.
Eligibility
Sex/Gender
ALL
Age
8 Years to 11 Years
Healthy volunteers
Yes
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. \-
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Well-being | post-test (2-4 months after intervention) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child Well-being | Post-post survey: One year after the intervention | 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. |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 138 |
| 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. | 128 |
| Total | 266 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 45 | 30 |
Baseline characteristics
| Characteristic | Program Group | Comparison Group | Total |
|---|---|---|---|
| Age, Continuous | 10 years | 10 years | 10 years |
| Depression | 2.63 units on a scale STANDARD_DEVIATION 0.25 | 2.71 units on a scale STANDARD_DEVIATION 0.23 | 2.67 units on a scale STANDARD_DEVIATION 0.24 |
| Race/Ethnicity, Customized Tribal members | 138 Participants | 128 Participants | 266 Participants |
| Region of Enrollment United States | 138 participants | 128 participants | 266 participants |
| Sex: Female, Male Female | 71 Participants | 69 Participants | 140 Participants |
| Sex: Female, Male Male | 67 Participants | 59 Participants | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 266 |
| other Total, other adverse events | 0 / 266 |
| serious Total, serious adverse events | 0 / 266 |
Outcome results
Primary
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)
Population: Children age 10-12 recruited from three different tribal communities, with program families recruited from children in schools, with program families agreeing to participate and families who did not participate allocated to comparison group. 4 intervention children and 2 comparison children did not complete post-survey (2-4 months). Because this average looks at the difference in mean change between two arms, therefore negative means are possible. This represents a change that is favorable.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Program Group | Child Well-being | -0.20 units on a scale |
| Comparison Group | Child Well-being | 0.05 units on a scale |
p-value: 0.02195% CI: [-0.45, -0.04]Mixed Models Analysis
Secondary
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
Population: Children ages 10-12 from three tribal communities that included children with their family caregiver who were recruited in schools. Children who responded were recruited into program group. Children who did not respond to participate in the program were allocated to comparison group. Some children did not have valid depression scale data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Program Group | Child Well-being | 0.06 change in units on scale |
| Comparison Group | Child Well-being | -0.01 change in units on scale |
p-value: 0.07595% CI: [-0.01, 0.15]Mixed Models Analysis