Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03924037 |
| Other study ID # |
18-031 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 27, 2018 |
| Est. completion date |
June 1, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
University of New Mexico |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Integrating Intergenerational Cultural Knowledge Exchange with Zero Suicide is an innovative
study in a Southwestern tribal nation that incorporates Zero Suicide into Indian Health
Services (IHS) primary care settings. The goal of this study is to determine the
effectiveness of Zero Suicide plus a cultural component (ZS+) (experimental group) compared
to Zero Suicide (ZS) alone (control group) on suicidal ideation, behaviors, and resiliency in
a randomized control trial of 138 AI youth ages 12-24 at two rural IHS clinics on the Pueblo
of San Felipe. The long-term goal of this study is to determine which is more effective at
reducing suicidal ideation and behaviors and increasing resiliency, ZS+ or ZS alone. Year 1
will focus on training providers on the Zero Suicide model and manualizing the Katishtya
Intergenerational Culture Knowledge Seminars (KICKS) curriculum that was piloted and
positively evaluated over the past three summers as a cultural module to improve the adoption
and acceptability of Zero Suicide. Years 2-4 will focus on participant recruitment,
assignment to experimental and control groups, and implementation. Year 5 will focus on data
analysis and dissemination. Data will be collected from all experimental and control group
participants at 4 time points: baseline, 12-weeks, 6-months and 9-months to explore the
effects of the intervention over time. The central hypothesis is that ZS+ will be more
effective then ZS alone. The investigators propose three aims: (1) Specific Aim 1: Using
Community Based Participatory Research (CBPR), partner with tribal stakeholders and
researchers to formally manualize the KICKS cultural module for Zero Suicide (ZS+); (2)
Specific Aim 2: To determine if adding a cultural component to the Zero Suicide model is more
effective at reducing risk factors and increasing resiliency in AI youth than Zero Suicide
alone; and (3) Specific Aim 3: Determine the essential features of the KICKS module for
adaptation by other tribes and disseminate the model.
Description:
Across the nation, suicide is the second leading cause of death in youth 10-24 years old.
This public health crisis is particularly acute in American Indian (AI) communities where the
suicide rate is 50% higher than that of non-Hispanic Whites. From 2009-2012, the age-adjusted
suicide rate for American Indian/Alaska Native youth ages 10-24 years old was alarmingly
higher than the overall rate for youth in this same age group nationally (14.66/100,000 vs.
8.25/100,000). In New Mexico (NM), the youth suicide rate is consistently at least 1.5 times
the U.S. rate at 14.2/100,000, which is 75% higher than the national average. Importantly, NM
has the highest proportionate AI population in the continental USA, and among the 22 tribes
in NM the youth suicide rate is even greater (21.4/100,000). Also in NM, the percent of
deaths due to suicide among AI youth by age range compared to all races is 29% vs.13% for
ages 10-14, 32% vs.18% for ages 15-19, and 25% vs.16.5% for ages 20-24.3 The Pueblo of San
Felipe, a tribal nation in NM and the target population for the proposed study, has
incredibly high rates of suicidal ideation and behavior with 21.8% of students reporting that
they seriously considered suicide, 14.9% reporting that they made a suicide plan, and 11.6%
reporting that they attempted suicide in the past year compared to 19%, 11.3%, and 7%
respectively statewide. A recent school needs assessment of over 300 students found even
higher rates, as 40% of youth expressed feeling frequently depressed within the last year,
17% reported feeling sad or depressed most or all of the time within the last month, and 30%
noted they attempted suicide one or more times within the last month. Thus, suicide is of
grave concern to tribal communities in NM, especially the Pueblo of San Felipe, and
developing systematic strategies for reducing suicide among AI youth is of utmost importance.
Risk Factors Associated with Youth Suicide. The probability of attempting suicide has been
found to dramatically increase as the number of risk factors increases. Research on suicidal
behavior in youth indicates that the odds of experiencing suicidal ideation and/or suicide
attempts are nearly three times more likely if the youth is using alcohol. Even more
concerning is that the odds of a completed suicide are five to 13 times greater for youth
diagnosed with a substance use disorder.6 Furthermore, lethality of suicide attempts
increases with alcohol use, and 40% of suicide attempts and 37% of suicides preceded by acute
use of alcohol. While depression is associated with suicidal behavior, depression predicts
suicide attempts significantly less well when controlling for substance use. Similarly,
exposure to violence, including domestic and intimate partner violence, increases the
probability of suicidal ideation and behaviors, as does historical trauma (defined as the
cumulative emotional and psychological wounding across generations which emanates from
massive group trauma). Unfortunately, AI youth experience exceptionally high rates of these
risk factors, including substance abuse, exposure to violence, and the profound repercussions
of historical trauma (domestic violence, abuse, etc.). The proposed study addresses risk
factors by incorporating these topics into the cultural component of the intervention known
as Katishtya Intergenerational Culture Knowledge Seminars (KICKS), as they are NOT addressed
in Zero Suicide.
Resiliency as a Buffer. Resilience is also a critical component of suicide prevention.
Buffering is the idea that having resources, such as social support or cultural grounding,
can mitigate against adverse stressful events.16 The Buffering Hypothesis is a model linking
resilience to suicidality that focuses on beliefs, which buffer individuals in the face of
stressors. Resilience factors are viewed as existing on a separate dimension to risk which
act to moderate the impact of suicidality. The presence of these factors results in
resilience and the absence increases risk for suicidality. Resiliency factors include
internal protective factors (positive beliefs or feelings about oneself and satisfaction with
life), external protective factors (ability to seek resources helpful when faced with
personal difficulties), and emotional stability (positive beliefs about one's ability to
regulate suicide-related thoughts and behaviors when confronting emotionally distressing
events). Importantly, research shows that increasing protective factors can be more effective
at reducing the probability of suicide attempts for AI youth then decreasing risk factors,
and other studies indicate that interventions are only effective to the extent that they
recognize and promote AI cultural values, traditional practices, and cultural identity
development. Thus, to improve suicide prevention program acceptability and adoption it is
critical to include culturally relevant strength-based and resilience focused components to
suicide prevention models.
Relationship between Suicide and Health Disparities. Health disparities are "preventable
differences in the burden of disease, injury, violence, or opportunities to achieve optimal
health that are experienced by socially disadvantaged populations". Barriers to mental health
care utilization for AI youth include: lack of culturally competent treatment providers, a
general mistrust in services provided within a Western medical model, and personal
experiences of discrimination in health care settings. These barriers have been found to
reduce the likelihood of seeking care, even when suicidal ideation or behaviors are present,
thus, contributing to the higher incidence of youth suicide in AI communities. The proposed
study addresses disparities in access and acceptability by adding a cultural component to the
Zero Suicide model.
Call to Develop and Test Innovative Suicide Prevention Models. In 2014, the National Action
Alliance for Suicide Prevention's Research Prioritization Task Force published strong
recommendations regarding the need to develop and test feasible and effective suicide
prevention interventions. Although there have been considerable studies focusing on youth
suicide prevention there is insufficient evidence to know which strategies are most effective
in preventing suicide among AI populations. Importantly, AI adolescents experience
significant risk factors for suicide, including substance abuse and exposure to violence
(e.g., physical and sexual violence, domestic violence, intimate partner violence, and
premature death of relatives due to violence, accidents, or suicide).5 Although suicide
prevention has been shown effective in reducing suicidal ideation and behaviors with youth,
there are limited Randomized Control Trials (RCTs) focused on preventing suicide attempts in
AI youth populations, thus it is unclear whether the results of previous studies are
generalizable. Critically, examining the effect of suicide prevention interventions in AI
primary care settings is vital as the majority of individuals who die by suicide (80%) have
contact with a primary care clinician or Emergency Department (ED) in the year prior to
death. There is promising research on the effectiveness of Zero Suicide (ZS), a
population-based model implemented through a large HMO system in the Midwest. However, ZS has
not been studied with AI populations or in tribally-based Indian Health Service (IHS) primary
care settings. Additionally, ZS does not include culturally-adapted interventions, which have
been found to produce larger effect sizes than un-adapted interventions for minority
populations.
The Zero Suicide Model. ZS is a population health-based approach to suicide prevention
underscoring the belief that suicide deaths are preventable and that individuals are often
not recognized in fragmented, busy health care systems.27 Studies of the Perfect Depression
Care program, the precursor to ZS, showed significant findings including an 82% decrease in
suicide deaths between baseline and intervention in a large urban Midwest health System. ZS
has seven essential elements for health care systems, including: (1) Lead- create a
leadership-driven, safety-oriented culture committed to reducing suicide for people under
care; (2) Train- develop a workforce that understands and responds to depression and suicidal
behaviors; (3) Identify- universally screen and assess suicide risk; (4) Engage- ensure every
individual has timely and adequate pathways to care and includes a brief safety plan (5)
Treat- use effective, evidence-based treatment, such as Cognitive Behavioral Therapy-Suicide
Prevention (CBT-SP), to target suicidal ideation and behaviors; (6) Transition- provide
continuous contact and support, especially after acute care; and (7) Improve- apply a
data-driven quality improvement approach to inform system change and improve patient
outcomes. The ZS toolkit provides resources on these elements, including training manuals, an
organizational self-study, work plan template, and consumer engagement strategies. The need
for consideration of cultural adaptation is indicated (zerosuicide.sprc.org) but not
specified.
Importantly, data is available on the effectiveness of each of the ZS elements. For instance,
training with booster sessions for healthcare professionals in primary care and ED settings
has been found to improve identification of suicide warning signs and willingness to refer
patients for mental health services, and to reduce suicidal behavior in situations where the
roles of gatekeepers are formalized and access to treatment is readily available. Findings
also support the importance of integrating brief universal screening in primary care settings
to quickly identify at-risk individuals and prompt healthcare professionals to make
referrals. Research found that there was a four-fold increase in the detection of suicidal
ideation by pediatricians when screening tools were used in outpatient clinics. Additionally,
pediatric ED studies show screening for suicide risk can reveal previously undetected
suicidal ideation in youth presenting with medical complaints. Importantly, screening must
confidently rule out patients with no appreciable risk, and balance feasibility with
effectiveness. Finally, research supports the importance of feasible and acceptable treatment
such as CBT-SP for those identified as being at risk for suicidal ideation or behaviors.
CBT-SP has been found to result in a greater reduction of suicidal ideation than treatment as
usual, and consists of a chain analysis of the index suicide attempt, and development of a
safety plan and individualized treatment plan to reduce reattempts.
Implementation of ZS in AI Communities is NOT Enough. Importantly, implementing ZS in tribal
communities requires cultural adaptation. As noted earlier, culturally-adapted interventions
have been found to produce larger effect sizes than un-adapted interventions for minority
populations. In addition, research indicates that substance abuse and exposure to trauma are
significant risk factors impacting suicide in AI youth. Finally, strengthening protective
factors may be more important than reducing risk factors in addressing suicide for AI youth.
ZS does not focus on reducing risk factors and increasing resiliency. The proposed study
incorporates all of these elements into the KICKS component, thereby increasing the
appropriateness and acceptability of ZS for AI populations.
Importance of Cultural Adaptations to Improve Suicide Outcomes among AI Youth. For ZS to be
adopted, implemented, and sustained in tribal communities, cultural consideration is
critical. Two large studies found that for AI youth strengthening protective factors may be
more important than reducing risk factors in addressing suicide, and mentoring from parents,
extended family, teachers, and friends helps AI youth overcome failure, succeed in school,
and develop resiliency. Engaging youth in teachings on traditional narratives, beliefs and
practices, and intergenerational approaches that focus on communication and awareness across
generations have also been found to increase resiliency. Moreover, research demonstrates that
elders play a critical role in fostering resilience by providing mentoring, teaching, and
social support to AI youth through transmission of valuable cultural beliefs, traditions, and
practices. The proposed study incorporates all of these elements to reduce suicidal ideation
and behaviors and increase resiliency.
Katishtya Intergenerational Culture Knowledge Seminars (KICKS) Cultural Adaptation. The
cultural adaptation proposed in this study is the Katishtya Intergenerational Culture
Knowledge Seminars (KICKS), an intergenerational program to promote resiliency and positive
connections between San Felipe youth and elders. Over the past three years, San Felipe
developed and piloted KICKS, where elders share traditional culture, language, lifeways, and
history with San Felipe youth in an eight-week daily seminar. KICKS was developed to improve
resiliency through exposure to intergenerational cultural teachings, and preliminary data
indicates that over 90% of youth felt they acquired substantial knowledge of each of the
traditional activities, indicating that KICKS fostered learning and resiliency. Well received
by tribal members and tribal leadership, KICKS is a perfect cultural module to increase
resiliency and improve acceptability and adoption of ZS.
Partnership as a Predictor of Behavioral Health Outcomes. Another potential variable is the
quality of stakeholder partnerships. In the last decade, the literature on CBPR has moved
beyond a focus on partnership processes and improved success at recruiting participants, to
recognizing the significant evidence of its impact on health outcomes. Adherence to CBPR
principles and strategies show positive impacts on health behavior, self-efficacies,
perceived social support, empowerment, and improved health status; as well as improved
policies to reduce health inequities. Mental health outcomes in particular have been shown in
the community engagement arm of an extensive RCT. UNM's ten-year study on quantitative and
qualitative methods to assess partnering processes and their associations with outcomes will
prove invaluable for measuring the quality and impact of the community partnership in San
Felipe. These assessments will be critical to determine the partnership's impact on the
identified outcomes. They will also support a mutual iterative learning process that will
contribute to ongoing research capacity building within the tribe itself for greater
sustainability of the intervention over time.
Benefits of Transdisciplinary, Multi-Level and Multi-Domain Interventions. Finally, in
perfect alignment with the mission of the Transdisciplinary Research, Equity and Engagement
Center for Behavioral Health (TREE Center), Integrating Intergenerational Cultural Knowledge
Exchange with Zero Suicide is a transdisciplinary, multi-level suicide prevention
intervention study that addresses resiliency and risk factors related to AI youth suicidal
ideation and behaviors. Effective health disparities interventions benefit from
transdisciplinary, multi-level and multi-domain components. The transdisciplinary research
team represents disciplines across the University (e.g., Psychology, Psychiatry, Public
Health, Clinical and Translational Sciences) as well as community partners across
child-serving tribal programs (e.g., Primary Care, Behavioral Health, Education, Social
Services) collaborating on the creation of an innovative AI youth suicide prevention model.
This also study employs a multi-level intervention approach. The first level is the
Individual level (youth who receive universal screens and participate in the ZS or ZS+
intervention). The second is the Group level (KICKS is provided in a group format), and the
third is the Community level (elders who participate in the KICKS module, school impacted by
providing universal screens at the SBCH, and larger community impacted through ZS
implementation in all primary care settings). This multi-level approach enables us to
understand issues of inequities in health and monitor the outcome of the intervention across
levels. This study also aims to reduce behavioral health disparities by simultaneously
addressing the needs and stressors of AI youth across multiple domains including behavioral,
sociocultural and health care system.
Summary. Because suicide is a low base rate behavior, very large samples are needed to
conduct adequately powered suicide prevention trials. Suicidal ideation and behavior,
however, are often warning signs of completed suicide, making it especially important to
target in intervention studies. Given the research supporting ZS and the fact that Indian
Health Services (IHS) identified "Zero Suicide [as] a call to relentlessly pursue a reduction
in suicide for those who come to us for care," there is a clear recognition that ZS is a
promising practice for tribal behavioral health. However, resilience-focused approaches, such
as KICKS, must be included, as must reduction of risk factors related to substance abuse and
violence. Thus, the current proposal will examine differences in reducing suicidal ideation
and behaviors, and increasing resiliency for AI youth who participate in ZS vs. ZS+.
APPROACH Study Overview. The proposed project will manualize the KICKS module and then
conduct a Randomized-Controlled Trial (RCT) of Zero Suicide (ZS) and Zero Suicide plus
Katishtya Intergenerational Culture Knowledge Seminars (ZS+) in AI youth ages 12-24 years old
from the Pueblo of San Felipe. It is transdisciplinary and multi-level collaborative research
project between the University of New Mexico, the Pueblo of San Felipe, IHS clinics; and
community stakeholders (e.g., youth, elders, family members, health care providers, tribal
leadership).
Community Advisory Committee. The investigators will form a Community Advisory Committee
(CAC) for this study in San Felipe comprised of tribal program representatives from
Behavioral Health, Primary Care, Social Services, Schools, Recreation, Tribal Leadership, UNM
researchers, other stakeholders. Dr. Altschul (MPI) and Ms. Tenorio (PD) will use a CBPR
approach to co-facilitate the CAC and guide all aspects of the study including, refining data
collection methods, participant recruitment, implementation, data analysis, and
dissemination. One CAC member will also serve on the NM TREE Center Community Scientific
Advisory Council.
Specific Aim 1: Using CBPR, partner with tribal stakeholders and researchers to formally
manualize the KICKS cultural module for Zero Suicide (ZS+). The objective of Specific Aim 1
is to develop a manual for the KICKS cultural module of ZS+ using a CBPR approach. To obtain
this objective the investigators will develop a community-based workgroup, the KICKS Review
Committee, to collaboratively formalize the KICKS module. The rationale for this Aim is that
having a manualized intervention will increase fidelity to the KICKS module, and ensure
delivery that is culturally appropriate, feasible, and effective. When the proposed research
for this Aim has been completed, the investigators expect to have a formalized manual that
will be used to consistently implement KICKS and to test Specific Aim 2 to compare
implementation of ZS+ vs. ZS alone in the San Felipe IHS clinics.
Research Design and Method. KICKS was developed in 2014 for youth to see that cultural
knowledge is key to resiliency, language is vital to maintain traditions, and Native people
were given many gifts from the Creator, including natural supports and protective factors,
that enabled their survival for centuries. Youth and elders met daily for 8-weeks and
participated in Keres language instruction, traditional storytelling, Pueblo history,
traditional dances, crafts, and visiting traditional and cultural sites. Youth learned about
proper introductions using AI name and clan; the traditional naming process; family
extensions/kinship; types and uses of corn; Pueblo history including emergence, migration and
settlement; traditional prayer; clan responsibilities; traditional crafts (pouches, arrows,
dance regalia); language and item identification; respect, acknowledgement, acts of kindness,
and cultural responsibilities; traditional dances, including regalia
identification/significance; and traditional cooking, sewing, and pottery making. In
exchange, youth taught elders about modern technology, including email access, use of iPads,
etc. This intergenerational knowledge sharing created positive outcomes for both youth and
elders, including increased self-reported resiliency.
Development of the KICKS module will occur through the KICKS Review Committee, including the
KICKS Coordinator, elders and youth who participated in the KICKS pilot, university
researchers, and other interested parties. The Committee will meet twice monthly for 8 months
to review agendas from the KICKS pilot, discuss successes and challenges noted during the
pilot, identify core content areas, consider potential additions, and discuss flow of the
curriculum. Although there are agendas for each KICKS session, it is important to manualize
the program so that the module can be followed with fidelity throughout the study. In
addition, certain topics, such as historical trauma and substance abuse, were not explicitly
included but will be added due to their importance as potential risk factors for suicidality.
This process will use CBPR strategies to ensure collaboration with community partners during
all phases of research, including study design, implementation, data collection,
interpretation, and dissemination. UNM data collectors will gather detailed qualitative
meeting minutes to document progress made and identify themes that emerge for inclusion in
the manual. The final manual will be presented to Tribal Leadership and the Tribal Council
for review and approval. This CBPR process recognizes the significance of culture in research
design and implementation to facilitate relevance to the community, ethical conduct, external
validity, and effectiveness.
Specific Aim 2: To determine if adding a cultural component to the Zero Suicide model (ZS+)
is more effective at reducing risk factors and increasing resiliency in AI youth than Zero
Suicide alone (ZS). The objective of Specific Aim 2 is to assess the effectiveness of ZS
enhanced with a cultural module (ZS+) compared to ZS alone at reducing suicidal ideation and
behaviors and increasing resiliency. To achieve this objective, the investigators will test
the working hypothesis that ZS+ will be more effective then ZS alone in reducing suicidal
ideation, behaviors and attempts. The rationale for Aim 2 is that successful completion of
the proposed research will contribute a missing, fundamental element to the suicide
prevention knowledge base critical to the development of a youth suicide prevention program
designed and tested with AI youth and found to be culturally appropriate, feasible, and
effective. Achieving these outcomes will collectively inform the suicide prevention field
about the effectiveness and feasibility of implementing ZS and ZS+ in IHS primary care
settings, and provide a greater understanding of the potential mechanisms that reduce
suicidal ideation and behaviors and increase resiliency for AI youth, a much-needed finding
in Indian Country. Achieving these outcomes will also inform the field about the adoption and
acceptability of the ZS model; and whether the quality of the community stakeholder
partnership is a predictor of behavioral health outcomes.
