Family Listening Program: Multi-Tribal Implementation and Evaluation
Phase: NA
Conditions: Substance Abuse
Sponsor: University of New Mexico

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Family Listening Program: Multi-Tribal Implementation 
and Evaluation: 
 
NCT# 03142009 
 
 
Document Date:  9.19.2014 
 

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1) HRPO Protocol Title (Version #1 and/or Version Date: 9.19.2014) 
IRB#14-289 
 
Family Listening Program (FLP): A Multi- Tribal Implementation and Evaluation 
(National Institute of Drug Abuse Grant #1R01DA0371740 01) 
 
2) IRB Review History 
We are seeking approval of this protocol which is a result of a successful Community 
Based Participatory Research (CBPR) partnership with Jemez Pueblo, Ramah Navajo, 
and Mescalero Apache in the piloting of the Family Listening/Circle Program (FL/CP) 
through two different studies funded by the Native American Research Center for Health 
(NARCH III 2005-2009 & IV 2009-2014). This new protocol submission is required due 
to new NIDA funding (1R01DA037174-01, 2014-2019) with an expanded more rigorous 
research study with the three tribal communities: Jemez Pueblo, Ramah Navajo, and 
Mescalero Apache. With the initial piloted studies completed FL/CP established working 
Tribal Research Teams (TRTs) from the Pueblo of Jemez, Ramah Navajo, and Mescalero 
Apache which are still intact and 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. 
The feasibility and piloting trials (first in the Pueblo of Jemez and Ramah Navajo, under 
HRRC #6-113; and then in the Mescalero Apache Nation, HRRC #11-217 & SWT-2011-
005), produced the program design and curricula for each tribe; and the common 
recruitment design for participants, consent forms, measurement tools for parents and 
children, and data collection procedures which will all be used in the new effectiveness 
trial. More specifically, the feasibility trial with Mescalero Apache enabled us to refine 
our protocols from previous HRRC#6-113, such as the measurement tools (reducing 
number of questions and taking out unnecessary and more invasive questions).  
 
3) Objectives 
The purpose of the research project is to utilize a participatory research approach in 
partnership with three communities to test the effectiveness of an existing 
intergenerational culturally adapted curriculum. With Native American Research Centers 
for Health (NARCH) funding, the FL/CP was co-created and pilot tested by CBPR 
partnerships between the University of New Mexico Center for Participatory Research 
(UNM-CPR) and three tribal communities, the Pueblo of Jemez, Ramah Navajo and 
Mescalero Apache. These existing long-term partnerships have co-produced the tribal-
specific FL/CP curriculums in Pueblo, Navajo and Apache versions. This CBPR project 
supports the rigorous testing of the intergenerational Family Listening/ Circle Program as 
a culturally centered and evidence based prevention program that has produced promising 

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preliminary data in reducing substance abuse risk factors for elementary school children. 
This grant will not only aggregate sufficient numbers to test FL/CP effectiveness but also 
illustrate how an intervention can disseminate and share “evidence- based processes and 
components” and also integrate understandings from implementation and CBPR science, 
that culture and community context must be integrated for the intervention to be effective 
and to generate community ownership. The R01 specific aims over a five year period are 
as follows: 
 
Aim One:  
Rigorously test the effectiveness of the Family Listening/Circle Program (FL/CP), 
with a comparative longitudinal design within and across three small tribal 
communities, with 4th graders to prevent substance abuse initiation disparities and to 
strengthen family well-being. Through a quasi- experimental longitudinal design, we will 
test effectiveness of the FL/CP prevention program with an intervention group of 4th 
graders as compared with other 4th graders, both within and across the three tribes. 
Quantitative pre-, post-, 6- month and 1 year –post measures of substance abuse risk and 
protective factors will be triangulated with qualitative data, also comparing children and 
parent responses on psycho- social factors, family communication and cultural 
connectedness. Process evaluation will assess satisfaction, quality, and fidelity to both core 
evidence and specific cultural curriculum components. 
Aim Two:  
Through CBPR, to support the three Tribal Research Teams (TRTs) to transform 
their research capacities into local prevention research infrastructures and a shared 
partnership. Building from the strengths of UNM-CPR’s partnership with Jemez to help 
coordinate the 3 tribes in the trial, each TRT will receive trainings in advanced CBPR and 
prevention science, with annual collaborative face-to-face TRT meetings to share lessons 
learned and support local tribal structures for future prevention research and programs. A 
novel CBPR conceptual model will guide evaluation of UNM-CPR and TRT partnership 
processes to assess effectiveness in fulfilling grant objectives and in reducing substance 
abuse. 
Aim Three:  
Assess additional program effects on other health, education and youth programs and 
leaderships within the three tribes. The FL/CP has potential for deep cultural 
embeddedness and community integration into other health and education prevention 
programs. We plan to assess knowledge about FL/CP and effects on tribal programs and 
leadership by interviewing people with varying degrees of closeness. Through interviews 
with program managers, staff educators, and tribal leaders, we will assess implementation 
and diffusion outcomes, such as potential for sustainability, pathways of information 
exchange, level of integration of curriculum into other programs, and multi- program 
collaboration. 
In sum, the tribes and the University of New Mexico Center for Participatory Research 
are building on committed CBPR partnerships to test the effectiveness of our innovative 
culturally-centered evidence-based and empowerment intervention with its integrated 
theoretical model. This grant provides an opportunity to reduce substance abuse in three 
tribes, to strengthen research capacity among tribal partners for future prevention 
research and programs, and to make a difference in substance abuse prevention research 

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designs nationally, showcasing how CBPR can integrate evidence-based interventions 
with cultural-specific contexts. Our FL/CP intervention, consisting of a CBPR process, 
that reintegrates culture into an evidence- based core, will then be available as a key 
model for other tribes across the nation.   
 
4) 
Background 
The three pilots co-created the tribal specific curricula (using the background rationale 
crossed out above) incorporating both evidence-based family strengthening approaches 
and cultural and community knowledge and evidence to embed the program within each 
specific tribal community. The three pilots also established committed partnerships 
through the feasibility trials who now have the capacity to co-implement and co-lead the 
effectiveness trial.   
SIGNIFICANCE for RO1: The epidemiology of American Indian (AI) substance abuse 
disparities has been well-documented (Beauvais, 1980; Beauvais, 1992; Beauvais, 1996; 
Mail and Johnson 1993; Okwumabua and Duryea 1987; Swaim, 1989) with Als suffering 
disproportionately from alcohol, illegal substance use, and suicide when compared to 
other races [NMDOH, 2007; Szlemko, Wood and Thurman, 2006]. Nationwide surveys 
have found that both current drinking and heavy drinking are most prevalent among Als 
(Miller, 1996). Alcohol and illegal substance use have been strongly associated with 
suicide attempts by AIs nationwide (Borowsky, 1999). From the US 2010 Census, the AI 
population of New Mexico (NM) was 10.1% of the total compared with 1.2% nationally. 
Proportionally, about 43% of this population was under 25 years of age (United States 
Census, 2010). According to the 2012 New Mexico's Racial & Ethnic Health Disparities 
Report Card, American Indians had the highest alcohol-related mortality rate of 
97.3/100,000, compared to 50.8 deaths per 100,000 for all New Mexicans (NMDOH, 
2012). In 2011, the NM Youth Risk & Resiliency Survey reported that for AI children 
grade 6th- 8th binge drinking rate 6.4%, and rate of children drinking before the age of 11 
as 12.3%. In the same year for AI youth grades 9-12, respective rates for each NMYRRS 
category was 38.6% ever drank, 24.7% current drinking, and 28.4% reporting they drank 
before the age of 13 (NM Youth Risk and Resiliency Survey, 2009). These youth are 
linked to alcohol/drug abusing peer clusters, and poor family and peer group associations 
(Oetting, 1989). Youth suicide rates for NM (all races) is more than double the national 
rate, with AI suicide rate nearly 4 times the national rate (NMDOH, 2012), and the 
attempted suicide among NM AI youth was 10.5%. For NM AI children (grades 6-8) the 
rate of suicide ideation was 24.6%, compared with 19.8% for all other NM children (NM 
Youth Risk and Resiliency Survey, 2009). Early substance use onset shows AI children 
begin using alcohol and other drugs earlier than any other ethnic group (Beauvais, 1996) 
due to multiple factors, including ineffective parenting strongly associated with parental 
substance abuse (Conger, 1997; Conger, 1991; Loeber, 1998), conduct disorder 
transmitted across generations (Gottesman and Goldsmith, 1994; Lahey, 1988; O’ 
Connor, 1998; Silvery, 1996), and ineffective family sanctions, partly associated with the 
historical trauma of boarding schools which removed many of the current parents from 
their protective community and cultural norms (Duran, Duran and Braveheart, 1998; 
Duran and Duran, 1995). Peer pressure (Conger, 1997; Conger, 1991; Duncan, 1995; 
Dinges and Oetting, 1993) and early onset are also critical risk factors and predictors for 

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AI youth alcohol use or progression to other substances (Hawkins, Cummins and Marlatt, 
2004; Kandel, Yamaguchi and Chem, 1992). 
Child Protective Factors and Theoretical Approach: Despite the risks, universal primary 
prevention programs have been shown to be effective at deterring AI experimentation 
with alcohol and drugs if they occur prior to initial substance use (Hawkins, Cummins 
and Marlatt, 2004). Work with 4th graders who are on the brink of early adolescence, 
with its challenges of role confusion and identity crises, provides an optimal time for 
influencing a key turning point so that these youth experience success in personal 
relationships or task accomplishment that may change their lives to a more adaptive 
trajectory (Rutter, 1987). According to the 2011 NM YRSS, "Students with close 
relationships with their parents, teachers, peers, and adults in the community were less 
likely to engage in risk behaviors. Students who said it was 'very much true' that they had 
a parent or guardian in the home who 'talks with me about my problems' were less likely 
than other students to smoke cigarettes (13.0% vs. 23.0%), use cocaine (2.4% vs. 6.4%), 
binge drink (16.5% vs. 25.0%), or attempt suicide (4.7% vs. 10.4%)" (NMYRRS, 2009). 
FL/CP adopts this positive youth development model following successful programs, 
which "strengthen social, emotional, behavioral, cognitive, and moral competencies; 
increase healthy bonding with adults and peers; and combine the resources of the family, 
the community, and the school" (Catalano et al, 2004). To support positive youth 
development, family-strengthening approaches (Kumpfer, Molgaard, & Spoth, 1996; 
Brody et al, 2012; Whitbeck et al, 2001) are based on social cognitive theory, building 
self-efficacy and skills in parent and child communication (Bandura, 1977); problem-
coping strategies which help children avoid psychological distress (Dumont and Provost, 
1999); as well as greater bonding with and reliance on parents. 
Whitbeck et al. (2002), identified enculturation (or cultural connectedness, measured by 
participation in traditional activities, cultural identification, and spirituality) as another 
protective factor and buffer against the negative impact of discrimination for AI adults; 
and particularly for children, aged fifth to eighth grade to impact academic success 
(Whitbeck, 2001). Enculturation was also found to have indirect effects on depressive 
symptoms, suicidal ideation; and self-esteem, supporting growing research that cultural 
values and practices serve as protective factors for AI children (Coggins, Williams, & 
Radin,1997), with strong cultural identification as one of the most important for 
increasing self-efficacy, school performance and abstinence from drugs and alcohol 
(Whitbeck et al, 2001). Core Indigenous theory in education also showcases how culture, 
language, and community are central to learning (Pankratz et al, 2006; Cajete, 1994). 
Cultural indigenous theory is particularly important for alcohol abuse in that AI age-
specific expectations and sanctions against deviant behavior have been weakened due to 
discrimination and disruption of cross- generational traditional teachings (Duran, Duran, 
& Braveheart, 1998; Duncan et al, 1995); and that mainstream individualistic refusal 
skills, found in some evidence-based approaches, may conflict with tribal values of 
belonging to the collective. Finally, empowerment theory also bolsters collective 
protective factors, with youth who increase their self-efficacy to work with each other 
and participate in community action showing improved mental health and educational 
outcomes (Wallerstein, 2006; Altman & Feighery, 2004; Holden et al, 2004; Berg, 
Coman, & Schensul, 2009). The central method of empowerment comes from Brazilian 

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educator Paulo Freire (1970) who promoted learning through listening, dialogue, and 
community actions (Lipari, 2010; Wallerstein & Auerbach, 2004), processes consonant 
with cultural tribal norms of listening, respectful dialogue, and collective responsibility. 
5) 
Inclusion and Exclusion Criteria 
Inclusion criteria includes any families from Mescalero Apache, Jemez Pueblo and 
Ramah Navajo with a fourth, grade aged child and their parents or guardian, and 
grandparents who will volunteer to participate. 
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 grade. The inclusion for the comparison group follows the same 
criteria, in having a child from the fourth grade and being tribal members, but who decide 
not to participate in the FL/CP program and are willing to assent/consent to take the pre 
and post-tests. 
6)  Number of Subjects (Recruitment Target) 
Target number of participants is 12 child participants and at least one 
parent/guardian in the family for a total of two members from one family, an 
expected 12 families annually for an overall total of 48 family participants over 
four years per community. Because of expected drop of 1-3 families (known 
attrition from our feasibility trials) by end of the twelfth session, we will initially 
recruit 13-14.  Comparison participant numbers will be 12 children and 12 
parent/or guardians.  
The expected sample size for the families will total 576 participants from Fiscal Years 1, 
2, 3, and 4 only (3 data collection waves total). Each wave per year will recruit 12 
Program and 12 Comparison families. Based on our multiple pilots with each tribe, we 
have determined a Family will be represented by at least 1 parent with 1 child; thus our 
participant totals (program & comparison) are 24 youth and 24 parents per tribe per year 
(48 participants X 3 tribes X 4 years (data collection waves) = 576). Furthermore, based 
on previous pilots with each tribe it is anticipated the sample will enroll more females 
than males at an approximate ratio of 70:30 and the majority of participating parents to be 
female.  
Table 2. 
FY01 (2014-
2015) 
FY02 (2015-2016) 
FY03 (2016-2017) 
FY04 (2017-2018) 
FY05 (2018-2019) 
Data 
Collection 
Sep 14' Mar 15' Sep 14' 
Mar 15' 
Sep 14' 
Mar 15' 
Sep 14' 
Mar 15' 
Sep 
14' 
Mar 15' 
*Wave 1 
Pre-
Test 
Post-
Test 
 
1-Yr Follow 
up 
  
  
  
  
  
  
*Wave2 
  
  
Pre-
Test 
Post-Test 
 
1-Yr Follow 
up 
  
  
  
  
*Wave3 
  
  
  
  
Pre-
Test 
Post-Test 
 
1-Yr Follow 
up 
  
  
*Wave4 
  
  
  
  
  
  
Pre-
Test 
Post-Test 
 
1-Yr Follow 
up 
* Each data collection wave (4 Waves totaling 288 families) includes three data collection points (pre, post,and 1 Yr 
Follow Up) for intervention & comparison families. 
WAVE TOTAL = 12 Program Families  (12 families X 3 tribes X 4 waves = 144 families (144 students + 144 parents = 288 
participants) 

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= 12 Comparison Families (12 families X 3 tribes X 4 waves = 144 families (144 students + 144 parents = 
288 participants) 
 
7) Recruitment Methods 
Members of the tribal research team will work with the schools from each 
community and will identify the potential participants from the fourth, grades of 
these schools. Letters will be sent home with the fourth grade children and TRT 
members; and by TRT members presenting to the children in their classrooms on 
the Family Listening Program and how interested students may participate in this 
research project. The attached recruitment letter will have minor changes by TRT 
members who will insert their contact information specific to each community. 
(see Attachment A). Should a child express an interest then the research team 
member will follow-up with the parents of the child and the compenents of the 
Family Listening/Circle Program will also be shared.  
Based on previous pilots with all tribes, all youth participants will be between 9-
10 years of age and be enrolled in 4th grade. Evidence of community support and 
the ability to recruit participants, implement measurement and protocols, and 
oversight exists through the previous feasibility trials and earlier grants and 
collaborative work. . At a minimum, Mescalero has 5 years, Ramah has 11 years 
and Jemez has 14 years of NIH research funded experience with the UNM Center 
for Participatory Research; which resulted with this multi-tribal application to test 
effectiveness. The current partnering opportunity stems largely from feasibility 
and development efforts, multiple pilot projects, presentations and publications. 
The Tribal Research Teams (TRTs) themselves, are also direct outcomes of 
previous Community-Based Participatory Research (CBPR) projects that have 
elevated Advisory Councils (typical of most CBPR projects) to more action-
oriented shared leadership bodies that co-design, co-implement and co- translate 
findings while providing direct research oversight through tribally-driven research 
and approval processes, and a multi-tribal/academic partnership connected 
together by UNM-CPR.  
Child and parent participants and child non-participants. Beginning in YR01 the 
TRT will begin recruitment, in a manner consonant with the feasibility trials.  The TRTs 
will make informal presentations in 4th grade classrooms and will send home  letters of 
invitation to participate. Letters will be given to all 4th grade students to take home for 
their parents review. The invitation letter will provide an overview of the FL/CP and 
invite interested parents and children to learn more. TRT and UNM team members will 
follow-up with interested parents individually. During the individual information session, 
potential participants will be told what FL/CP is and involves the primary language of the 
community (Towa, Apache and Dine languages respectively), or bilingually, with 
English depending on the preference of the potential participants. After learning about the 
intervention program, TRT researchers will determine whether the family is willing to 
participate. Research team members will be prepared to provide informed consent and 
answer any questions. However, potential participants will be encouraged to take time to 
weigh the costs and benefits of the program; they can take time to think about it and 
contact the research team member at a later date. If at a later date they decide to 

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participate, research team members will arrange a time to meet and perform the informed 
consent process. FL/CP participant families will be enrolled on a first come first serve 
basis. The self-selected 4th graders and parents who choose to participate will be drawn 
from a pool of candidates from several points of risk: the socioeconomic status of the 
students’ families is relatively low, living in areas of poverty, living in rural communities 
and the majority of students live in single parent households. Those not selected to 
participate or who decline to participate will be invited to take part in the research study 
verbally by TRT members (to take pre and 2 post-tests) as non-program participants 
serving as comparisons. The described recruitment process is the preferred method by the 
TRTs to date; because it ensures a) involvement with this study is entirely participatory 
and voluntary and b) an understanding of the research involved by potential participants 
is obtained and discussed to satisfaction of TRT members, with UNM research team 
members available as necessary. 
Leaders, managers, educators, and/or staff.  For the third aim of the grant, in the first 
program year, the UNM and community TRTs will conduct a review of community 
organizations and prevention and youth programs in the community and at schools. From 
this review of programs, the pool of managers and educators will be identified. 
Community/traditional leaders may not be affiliated with programs therefore we will rely 
on the community knowledge and connections of the Tribal Research team members to 
recruit these leaders. Starting in year 1 and continuing through year 5, TRT members will 
recruit those identified by phone or face-to-face communication. The consent process as 
detailed above will occur immediately prior to the individual interview. Potential 
participants will be contacted and interviews will be conducted during the fourth quarter 
of each program year. The described recruitment process is the preferred method by the 
respective TRTs because it ensures a) involvement with this study is entirely 
participatory and voluntary and b) an understanding of the research involved by potential 
participants is obtained and discussed to satisfaction of TRT members, with UNM 
research team members present and available as necessary. 
 
8) Study Timelines 
 
Attached updated study timeline (see Attachment B) 
 
9)  Study Endpoints 
Our final endpoint will be the collection in year 5 of the one-year post-test of the 
final program implementation groups in year 4.  A potential reason to terminate 
the study would be when there are no voluntary family participants. 
10) Research Setting 
 
Describe the sites or locations where your research team will conduct the research.  
 
The Family Listening/ Circle Program will be conducted in three tribal communities in 
New Mexico. The program is a dinner program with four facilitators and 12 families 
(child/parent/invited elders) held in tribal facilities, such as a school, a library, an 

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intergenerational center, and there is no other business taking place at that time. The 
UNM Center for Participatory Research (UNM-CPR) has invested in several CBPR tribal 
partnerships to create a bidirectional environment open to partnered research and to 
prevention programming that can be tested systematically to improve children, youth, and 
family wellness. Each partnership has been developed with UNM's commitment of 
regular (at least monthly) visits to each community, despite the rural distances; from 
Albuquerque, Jemez is one hour north, Ramah Navajo is 2.5hours west, and Mescalero is 
3 hours south. Described below is a brief overview of each tribe and history of each 
FL/CP partnered development. 
 
Jemez: The Pueblo of Jemez, with 3400 people, as the only Towa-speaking people, 
places language fluency at 80-85% [POJ, 2013], with the Hemish people practicing a 
high degree of traditional and cultural knowledge. The preservation of Towa and the 
Hemish ways of life remain a tribal priority in all facets of life, not only for the sake of 
cultural preservation, but also because health and educational attainment of tribal 
members is believed to be affected by loss of language and culture. Like many other AI 
communities, the Pueblo of Jemez faces challenges of high rates of alcohol use, 
substance abuse, and suicide. According to the 2009 Youth Risk Behavior Survey for 
Jemez, aggregating 9th-12th grades, 46.8% had drank alcohol in the past 30 days, with 
15.2% attempting suicide (Tribal unpublished data), in comparison to the national rate of 
7.8% [NMYRRS, 2009]. The partnership between UNM-CPR and the Pueblo of Jemez 
started in 1999 with 4-years of CDC funding to identify Pueblo cultural strengths, social 
capital, and community capacities. Focus groups and individual interviews with >60 
tribal members, including youth, identified the importance of cultural transmission of 
Hemish traditions and language, also coupled with concerns about intergenerational 
family breakdown and substance abuse; and a desire from elders and youth to engage 
with each other, but who also faced problems with communication [Wallerstein et al., 
2003]. With these findings, the Jemez Advisory Council requested help to develop a 
culturally-based family prevention intervention to start with younger-age children; and 
NARCH III (2005-2009 HRRC #06-113) was born, to co-develop a family program, with 
Ramah Navajo community as a second tribe. Jemez co-developed its version, conducted 
2 pilots and inserted elements into a summer youth program. Currently, UNM-CPR and 
Jemez (HRRC # 11-055) are also pilot- testing an intervention for high-risk high school 
youth, RezRIDERS, funded by NIDA, 2012-2015. 
 
Ramah Navajo. Tribal rolls estimate that there currently are 3,500 people in the Ramah 
Navajo community, with over 400 students in Pine Hills Schools, Head Start through 
12th grade, served by a full-time staff of 85. In terms of alcohol use, the 2003 Navajo 
Nation Middle and High School Youth Risk Behavior Survey (Tribal unpublished data) 
found that 40% of middle school students and 69% of high school students had more than 
one drink of alcohol in their lifetime; with 22% of middle school children using alcohol 
in the past 30 days. Furthermore, 36% of Navajo Nation middle school students and 67% 
of high school students had used marijuana during their lifetime (with 25% of middle 
schools students and 38% of high school students using it in the past 30 days), compared 
to U.S. rates for high school students of 42% lifetime and 24% for the past 30 days. The 
Ramah Navajo UNM-CPR partnership began in 2000 with CDC REACH funding to 

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develop community capacity to increase cervical and breast cancer screening. The Ramah 
Advisory Council requested help in creating a comprehensive community profile that 
would assess capacities as well as historic losses and a range of health, education, 
housing, and other community issues; and NARCH I funding was obtained [English, et 
al. 2004; Cashman, et al., 2008]. Cultural capacity items, which included elder and youth 
questions developed from the Jemez qualitative work [Oetzel, et al, 2011], were 
incorporated into the Ramah profile and led to a similar analysis: that cultural 
preservation was highly valued, but there were concerns for loss and family 
communication breakdown. The Advisory Council, similar to Jemez, requested help to 
develop a culturally based family intervention and joined in the NARCH III application 
to co-develop and contextualize the program within Navajo culture and language. One 
pilot test was conducted of the Ramah Navajo version of 10 families. 
 
Mescalero Apache: The Mescalero Apache Community with 4000 enrolled members is 
located in south central New Mexico; about 100 miles from the Texas border and is three 
hours south of Albuquerque.  There are three sub-bands, Mescalero Apache, Chiricahua 
Apache, and Lipan Apache, which comprise the tribe. Approximately one-half of the 
population is under the age of eighteen. Though Mescalero has a variety of well- 
established alcohol and medical treatment programs, which serve tribal members and 
others, the FL/CP was the first prevention program in Mescalero schools which is 
culturally centered and targets youth at the vulnerable age before the majority of 
experimentation begins. Under the Core of Albuquerque Area Indian Health Board's 
NARCH III, a community member from Mescalero Apache participated as an advisory 
member to the Scientific Community Advisory Committee since 2004; and had the 
opportunity to hear regular reports about the process and progress of the NARCH III 
FL/CP with Jemez and Ramah Navajo. As a result of hearing about the NARCH III 
Program, Mescalero requested to co-write NARCH V with UNM- CPR to co-develop an 
Apache version and implement the FL/CP within their community. With NARCH V, 
2009-2013 funding cycle, we adapted the FL/CP curriculum to Mescalero Apache 
cultural values and ways of life and conducted 2 pilot sessions with families. 
  
11) Study Methods  
Provide a step-by-step description of all research procedures in 
chronological order.  
a) The tribal research teams will recruit initially 13-14 families (knowing a couple 
families may drop based on pilot experience) to have 12 families from each tribe with 
fourth grade school children to be program participants. Families to include a child, 
parents, and elder family member. TRT members will recruit child participants and 
their parents and elders through invitation letters and through working with teachers 
to present in classrooms at each tribe’s local elementary schools that serve tribal 
children. In addition, 12 families will be recruited to be comparison families. 
b) Tribal facilitators, who are already trained, will train new facilitators (to expand the 
capacity within each community) in curriculum presentation/administration and 
process evaluations. 

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c) Tribal research team members, who are already trained, will administer pre/post and 
one-year post surveys with parent and child participants, and with comparison parents 
and children. UNM research team will provide support. We have chosen not to 
include elders in the quantitative instruments, as their primary (and sometimes only) 
language is the tribal language; elders do participate in mid-program and end of 
program discussions on program satisfaction and how program can continue to meet 
family needs.  The post-tests include two open- ended “360” questions: asking 
parents how their child and family have changed, and asking children, how their 
parent and family have changed. For this RO1, we have adopted the use of laptops for 
data input, at the request of the IRB to provide greater guarantee of confidentiality for 
the children and parents. 
d) Tribal facilitators will administer the twelve two to 2 1/2 hour sessions of the 
prevention/intervention family program UNM research team will provide support. 
Each of the tribes has trained facilitators (who are teachers, educators, behavioral 
health counselors, and prevention and cultural/language staff), with four needed for 
each FL/CP program implementation, two working with the adults and two working 
with the children during their breakout groups, and working together when the 
families are sharing what they learned. Each year, at least two trained facilitators will 
participate (overseeing the facilitation) and the TRTs will recruit and train others in 
subsequent years to expand the pool of tribal members knowledgeable about the 
program overtime. During the previous pilot funding, the UNM team provided 
training and support during the sessions. In this RO1, the tribal facilitators are trained 
and will be leading the curriculum. UNM team members will join periodically to 
provide support and to observe. Two of the facilitators in each group have taken the 
CITI training because they are also involved in data collection. All have been trained 
in confidentiality issues, motivational interviewing, facilitation of groups, and know 
the behavioral back-up protocols to refer children or parents if needed. (DSMP 
attached).  
e) The intervention curriculum follows the exact curriculum developed in the three tribal 
communities during the pilot funding. Based on the pilot experience, the curriculum 
has been formalized into a systematic common format, with twelve weekly sessions, 
held at dinnertime for 2 and 2 1/2 hours. The program is held in tribal facilities, such 
as a school, a library, an intergenerational center, and there is no other business taking 
place at that time. Occasionally a session is postponed to the next week due to tribal 
community events.  The twelve session themes are: 
Welcoming 
Tribal History (Part I) 
Tribal History (Part II) 
My Family 
Tribal Way of Life 
Community Vision 
Community Challenges 
Communication, Help Seeking & Problem Solving 
Recognizing Types Of Anger & Managing Anger 
Being Different & Positive Relationships 
Building Social Support 
Making A Commitment & Community Project Presentations 

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Each session starts with a collective dinner with families eating together (as a prevention 
strategy in itself), they then practice their Indian and clan names. The sessions are led by 
facilitators in their own language or bilingually, as interactive activities. The facilitators 
then divide the families into children and adult groups into separate rooms to address the 
theme of the session (with two facilitators per each group), and they then return together 
at the end of the session to share their learnings.  For example in the Visioning session, 
the adults create their pictorial visions using crayons and markers, the children create 
their visions, and then they get back together as a whole group of 12 families to share 
their visions from different generational perspectives. All the children are given a chance 
to share first, with some parents and elders sharing after. 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.  
f) Process data will be collected during program implementation. Our well-tested 
process instruments include: journals by children and parents as the last activity of 
each session, facilitator logs as to activities completed and quality of interaction 
observed, and discussion groups at mid-point and at the end of the Program.  
g) In YR01, for the third research aim of the grant, each TRT will collaboratively 
identify key individuals within each tribal setting, where program diffusion will be 
most evident, i.e. those with the strongest program links to FL/CP, such as educators 
who teach next to teachers who are facilitators in the Program, or other Program 
leaders who work with youth.  From YR01 though YR05, we will annually interview 
4 individuals (see Attachment C: Interview Guide) in each tribe to qualitatively assess 
what interviewees know and have learned about FL/CP; the extent to which they have 
incorporated ideas from FL/CP into their programs or classes (managers, staff, 
teachers) or decision-making (leadership); and if collaboration on substance abuse 
issues has increased with time through the diffusion processes. 
h) In YR01- YR05, TRTs will conduct an annual scan (through interviewing the school 
and/or youth program key informant, as part of the five interviewees) to identify other 
substance abuse prevention programs, culture and language programs, or integration 
of FL/CP cultural components into tribal programs to be able to plot these other 
resources against the FL/CP impacts. This scan will first take place at baseline. 
Rather than trying to prevent cross-contamination, we expect there will be diffusion 
of FL/CP program components as well as increased knowledge by other Health and 
Education staff and educators to create an environment where FL/CP can be 
sustainable to improve health and reduce substance abuse over the long term (beyond 
when the grant ends). 
i) Co-analysis of pre/post-test and process evaluations will be conducted  
j) Dissemination plan will be co-developed. 
 

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12) List of Appendices 
 
Attachment A: Family Program Recruitment Letter 
Attachment B: Study Timeline 
Attachment C: Tribal Leader and Managers’ Interview Guide 
 
13) Data and Specimen Banking 
No data or specimens will be banked.  
14) Data Management 
Upon consent/assent by family participants involving a child (4th grader), parent/guardian 
the pre/post survey will be conducted in three communities at a scheduled convenient 
meeting time in a pre-designated tribal facility that will comfortably accommodate the 
family participant members and the research team members, the meeting room will be 
closed to the general public to allow for privacy and confidentiality. Dedicated (4 per 
tribal site) laptop computers will be used in the tribes for data collection and the laptops 
will be HSC-UNM Novell network NetID protected (valid, unique user identification and 
privileges). UNM-HSC IT policy requires all users to maintain current authorizations and 
privileges to ensure maximum-security features are implemented. UNM and Tribal site 
coordinators will be issued user accounts, as per UNM-HSC IT policy for this purpose. 
All questionnaire data will be collected via Inquisite web-based assessment software on 
project laptops.  Data collected will be directly uploaded to the questionnaire vendor 
(Klein-Buendel, Inc., a health communication research firm in Golden, CO) server.  
Web-based programs are hosted on Klien Buendel's web server, a Dell Power Edge, with 
two 1.6 Ghz Xeon processors, 4 gigabytes of RAM, and three 72-gigabyte hard drives 
which operate off a hardware RAID5 system. Sensitive information and material for the 
project will be stored on this web server, protected by a hardware firewall (Cisco PIX). 
Each web server has its own native Windows security software. The Klein Buendel 
server uses a Secure Socket Layer (SSL) 128-Bit Encryption Key. All servers at KB are 
connected via 1 Gigabit high-speed switched network, insuring high-speed transfer 
between machines. All computers on the network are protected from viruses by Sunbelt 
Viper Enterprise.  A nightly backup of each computer provides protection against the loss 
of data. Questionnaire data will be transmitted from KB to project staff via password-
protected CDs securely mailed via Fedex. Once received, data will be stored on UNM-
HSC secure servers.  Only UNM research team members with unique Novell NetIDs and 
Tribal site coordinators and local tribal evaluators (all with required CITI training) will 
have access to secured data. Once on the UNM server, all data will be de-identified by 
individual, except for their tribal membership. Aggregated data will be available to TRTs 
for interpretation, upon data transmission and database construction (quantitative 
surveys) in order to minimize risks related to loss of confidentiality. Master databases 
containing all tribal waves, and aggregate data will be located on UNM-HSC 
workstations only. 
Quality assurance plan 
The UNM and tribal research teams will be responsible for data collection. Survey 
instruments have been adapted from reliable and valid sources from the literature, with 

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additional items of cultural appropriateness added from TRT input. Survey instruments 
will be designed for interactive laptop administration. 
 
The research team will log onto the secure password protected laptop to provide access 
for the adult participant to take the self-administered pre-web-based survey instrument. 
For the child participant, a local TRT or UNM research team member will again log onto 
the secure password protected laptop to administer the pre-web-based survey instrument 
by reading aloud each question to the child, who will have the laptop with the web-based 
survey to record each response directly onto the web-based survey behind a desk-top 
partition, assuring privacy. Once the adult and child pre- web-based surveys are 
completed the research team member will sign out of the program and shut down the 
laptop. The consent forms will be collected and placed in a separate sealed envelope and 
will be transported to UNM in Albuquerque and placed in a different locked filing 
cabinet in the same locked office of the PI for three years, after which time they (consent 
forms) will be destroyed according to university procedures in the destruction of hard 
copies of research documents. 
 
The administration of the post-survey will be conducted at the completion of the twelve 
week two-hour sessions of the FL/CP prevention/intervention program, and 1yr later and 
will follow the same steps taken in the administration of the pre-survey as outlined above 
for both the adult and child participant.   A comparison between pre/post and one year 
post survey will be conducted by t-testing of comparisons. Findings with statistical 
significance will be reported and an executive summary will be included. The research 
team will utilize a participatory approach and engage the tribal research team in the 
interpretation of the initial findings. Data will be interpreted by the UNM and Tribal 
Research Teams to ensure cultural appropriateness and reflection of the lived experience 
of community partners. Dissemination of findings for each community will be based on 
recommendation by the tribal research team. Past research experience with other tribal 
communities recommended the preparation of powerpoint slides with findings and brief 
executive summaries to be shared with tribal leadership and program staff. 
 
Qualitative data from program manager and leader interviews will be audio recorded 
and transcribed verbatim. The files will be read through completely then cleaned for filler 
utterances. The file will then be converted to rich text file document and uploaded into 
Atlas.ti qualitative software. Coding will occur inductively and a code sheet developed, 
themes will be developed from codes, then data will be thematically analyzed.  
 
15) Provisions to Monitor the Data to Ensure the Safety of Subjects 
For all studies considered greater than minimal risk, include a data and 
safety monitoring plan (DSMP) for reporting data monitoring committee 
findings to the HRRC and the sponsor  
See attached DMSP report.  

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16) Withdrawal of Subjects 
Taking part in this study is completely voluntary so participants can choose not to 
participate or withdraw at any time. If participants choose not to participate in the 
facilitated sessions or become unable to participate (i.e. unable to get off work), we will 
still seek to obtain all post and one year post assessments (using an intent-to-treat 
design).  
 
17) Risks to Subjects 
A potential risk that may occur during the twelve weekly two-hour sessions of the 
Family Listening prevention/intervention program in which session six includes a 
discussion of recognizing types of anger or session elven on being different, a child or 
adult may share a troubling experience due to being angry or being different.  If needed 
an individual will be referred to a counselor at the local health clinic. Each tribal 
community has access to a local tribal behavioral health program at the tribal health 
clinic. Any costs associated with counseling or other treatment will be the responsibility 
of the participant. Dr. Kamilla Venner, UNM Psychology Professor will also be 
available as a consultant to the FL/CP facilitators and tribal behavioral health units as a 
back-up clinical psychologist.  
 
A potential risk to participants is a loss of privacy, confidentiality, and emotional risk. 
All reasonable efforts to maintain and protect privacy and confidentiality for all 
participants will be made by the UNM team. University researchers each have multiple 
years of CBPR research experience (Dr. Wallerstein, over 25; Mr. Tafoya, over 10; and 
Dr. Belone, over 14; Ms. Rae, over nine; Dr. Woodall over 15), including human 
subjects and have maintained CITI certification. The likelihood of loss of confidentiality 
is low, given the UNM research teams experience with research. 
 
18) Potential Benefits to Subjects 
There may be no direct benefit to the individual family participants (parent/guardian, 
child, or elder family member), however a possible benefit may be improved 
communication and anger management skills between the parents/guardian, child, and 
family elder. For the parent/guardian an additional possible benefit may be improved 
parenting skills. For the child an additional possible benefit may be improved skills in 
identifying positive social support and an increase self-identification with any of the three 
tribes by gaining knowledge in history and important teachings. An overall benefit will 
be the input gained from the participants in the FL/CP twelve week two-hour sessions, 
the lessons learned by participation will contribute to improvements in the development 
of an empirically-based and culturally-centered family prevention/intervention program 
for the three tribes.  
 
19) Vulnerable Populations 
Inclusion of Children: There will be at least one child and one parent from each of the 12 
participating families in the family-based prevention program and 12 non-participating 
families in years one, two, three and four. Therefore this project will include a total of 24 
child participants per year in each tribal community for a total of 72 children per year (12 

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child participants + 12 child non-participants) X 3 tribal communities). It is expected 288 
children will participate in the FL/CP intervention project over the proposed four-year 
data collection period. 
 
20) Multi-Site Research 
The research takes place in three tribal communities with one University partner, the 
UNM Center for Participatory Research.  
 
21) Community-Based Participatory Research/Field Research 
Our CBPR approach has produced committed collaborative partnerships, which honor the 
ownership and direction from our Jemez Pueblo, Ramah Navajo and Mescalero Apache 
partners. Building from previous NARCH pilot grants with these tribes, we have in fact 
met the NARCH initiative goals: to reduce research mistrust; to develop a pipeline of AI 
research scientists through the capacity-building of our TRTs (with some interested in 
future MPH education) and core UNM-CPR Research Scientists; and to develop an 
intervention with preliminary data that has shown promise to reduce substance abuse 
disparities, with the R01 as the next step. Our approach has been grounded in well-
established CBPR principles of honoring community strengths and long-term 
commitments [Israel, et al, 1998; Israel, et al, 2012], as well as in indigenous CBPR 
principles of supporting tribal sovereignty and cultural renewal [Walters, et al, 2009; 
LaVeaux & Christopher, 2009]. CBPR has been recognized, not only as beneficial for 
reducing historic mistrust of research and addressing community priorities, but as 
strengthening translational science that addresses both internal validity as well as external 
validity to ensure effectiveness across diverse tribal communities [Wallerstein & Duran, 
2010; Minkler & Wallerstein, 2008]. As such, CBPR intentionally reflects 
implementation research concerns of how to best contextualize and culturally-ground 
interventions [Brownson, Colditz & Proctor, 2012], which is reflected in our tribal-
specific versions of FL/CP. 
This RO1 therefore: 1) supports multilevel understanding and assessment of the FL/CP 
prevention effectiveness through a quasi-experimental comparison between intervention 
and comparison children, with triangulation of quantitative and qualitative impact and 
process measures, and assessment of both core evidence-based and specific cultural 
components; 2) strengthens research skills of our tribal colleagues as co- researchers 
building upon research capacities gained from previous CDC and NARCH funded 
projects; 3) supports a within-tribe longitudinal (pre-post, 6-month post, and 1-year post) 
that compares program impacts on 4th grade children, their parents and families; and 4) 
enables an aggregated sample for testing FL/CP effectiveness with sufficient numbers to 
achieve statistical significance, given effect sizes for preliminary data; and as a scientific 
inquiry into the role of CBPR in translational research to reduce disparities in Indian 
country. 
As Cook and Campbell (1979) note, there are a wide variety of factors that make the use 
of randomization procedures in group designs difficult to impossible, especially in field 
research settings. In the present case, there are a number of factors at work that make the 
randomization of participants to either an intervention or usual and customary treatment 
group not feasible. First, the tribal communities that are participating in the proposed 

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project are small and close-knit, characterized by highly interwoven social networks 
[Cook & Campbell, 1979].  As a result, randomly assigning some children and families to 
the intervention group and not others is problematic because doing so would likely be 
socially disruptive. Second, the employment of randomization procedures in this setting 
implies a level of outside political control that is not achievable in tribal communities. 
These communities have histories of disadvantage and discrimination, and decisions are 
usually politically closed to those outside the community, research groups included. 
Third, the norm of collective equity and CBPR processes which honor tribal voice is 
prominent and strong, and randomization procedures can mitigate against the ethical 
responsibility to work towards tribal ownership and sustainability once the grant ends 
[Buchanan, Miller, & Wallerstein, 2007]. We propose therefore the use of a two arm non-
equivalent control group design with pretest, immediate post- test, and 12 month follow-
up assessment points (see Table 2 below). Among quasi-experimental designs that could 
be employed, this design carries several advantages over other designs in being able to 
infer causality [Cook & Campbell, 1979], and we shall follow data analysis procedures 
recommended by Cook and Campbell concerning this design. 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, we 
expect some degree of program diffusion in the comparison group families.  We will 
employ analysis procedures to examine this potential diffusion effect (see below in Aim 
3). 
 
Study Personnel – N/A 
Location – N/A 
Informed Consent – N/A 
Procedures – N/A 
22) Sharing of Results with Subjects/Incidental Findings 
All community-specific results will be shared back to the communities in 
aggregated form. UNM research team will work with the TRTs to determine the 
type of format (graphs, tables, pie charts, narrative) is most appropriate for sharing 
the results back with the community.  Aggregated results from all three 

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communities will be disseminated with guidance and participation from our TRT 
members through national presentations and publications.  
 
23) Resources Available 
The 1R01DA0371740 01 is funded by the National Institute on Drug Abuse, 
National Institutes of Health. See attached notice of award dated 03/14/2014.  
 
24) Prior Approvals/Attachments Requiring Signatures 
Describe any approvals that will be obtained prior to commencing the research. 
(e.g., school, external sites, funding agency, laboratory, radiation safety, or 
biosafety approval).  Upload the required Departmental Review Form signed by 
your department chair (or authorized designee if the PI is the Department Chair) 
into Click IRB under “supporting documents”.   
 
Letters of Support/ Approval have been obtained and are attached from various 
programs and tribal authorities (including tribal council and other resolutions) of 
each of the three participating tribal communities as well as the Albuquerque Area 
Southwest Tribal epidemiology Center and the office of several New Mexico 
Senators and Representatives.  
 
Study will require simultaneous approval from the Navajo Nation Institutional 
Review Board and the Southwest Tribal Institutional Review Board.  
 
25) Confidentiality 
All reasonable efforts to maintain and protect privacy and confidentiality for all 
participants will be made by the UNM team. All UNM and lead tribal site 
coordinators have successfully completed the CITI training and submitted conflict 
of interest forms. As a principal of CBPR our tribal research partners are to be 
involved in every stage of this research project. University researchers each have 
multiple years of CBPR research experience (Dr. Wallerstein, over 25; Mr. Tafoya, 
over ten; and Dr. Belone, over twelve; Ms. Rae, over nine; Dr. Woodall over 15), 
and likelihood of loss of confidentiality is low, however, the following procedures 
will be followed to add extra layers of protection. 
Quantitative survey data: Quantitative survey data: Due to the longitudinal pre-post 
test survey design; linking information will be required. Unique ID numbers for 
study participants will be a suffix code 3 characters long; the random number 
generator that comes standard with SPSS software will generate these codes. The 
first unique code will be sequentially assigned to consent forms. For example the 
first person to submit a consent form will be assigned to the first random number 
sequence. Each Unique ID will also have a prefix code 7 characters long; the first 
character/digit will be the tribal site identifier, the second character/digit will be the 
wave identifier. The next two characters/digits will be the family identifier 
(distinguishing intervention and comparison study groups), and final two 
characters/digits will distinguish whether parent or child population. Data will be 

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presented in aggregate format (means, medians, standard deviations, effect size) to 
each TRT for interpretation and subsequent analysis. 
Qualitative interview data: all interviews will be transcribed. During transcription 
identifiers such as names and relations will be stripped from the transcript in order 
for the respondent to remain anonymous, except for tribal affiliation will be 
maintained. The UNM and tribal research staff will take the lead in thematically 
analyzing the data and present it back to the TRT in thematic categories. 
 
26) Provisions to Protect the Privacy of Subjects 
Research documents that will be collected are consent/assent forms and they will be 
collected in the field, once signed or completed the documents will be placed in 
separate large sealed envelopes. The pre/post-survey will have no names or 
identifiers other than a numeric number allowing the PI to count the total number of 
participants. An electronic master list of numeric numbers and child and parent 
names will be kept in password protected file on Dr. Belone’s computer.  All 
completed consent/assent forms will be stored while still in their sealed envelopes 
in locked filing cabinets in the co-PI Belone’s locked office on a locked floor in a 
locked university building. Sealed envelopes will only be opened by PI of project.  
The privacy of consent forms for the key informant interviews will be kept 
confidential, and stored in sealed envelopes in locked filing cabinets in PI 
Wallerstein’s office.  
 
27) 
Compensation for Research-Related Injury 
 
This is a minimal risk project with sufficient psychological and behavioral services 
back-up within each community and with a UNM psychologist. We don’t expect 
any research-related injury to occur.  
 
28) Economic Burden to Subjects 
N/A  
Research Procedures 
Number of 
Samples/Procedures 
Responsible Party 
Study 
3rd Party Payer 
or Participant 
N/A 
      
 
 
      
      
 
 
      
      
 
 
Standard of Care Procedures 
Number of 
Samples/Procedures 
Responsible Party 
Study 
3rd Party Payer 
or Participant 
N/A 
      
 
 
      
      
 
 
      
      
 
 
 
• List any other costs to participants not already described above.  
 

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• Will participants be charged for the costs of an investigational drug/ device/ 
intervention?  
N/A 
• Explain who will be responsible for paying for treatment of adverse events. 
N/A 
Note: If sponsor will be responsible for treatment of research related injury, 
submit a copy of the Clinical Trials Agreement (CTA) for review. 
 
29) Consent Process (including waiver request for HIPAA, waiver of 
HIPAA for recruitment only, Waiver of Informed Consent, and 
Alteration of Informed Consent) 
 
Family Prevention/Intervention Program. The following will be conducted with the 
child and adult (parent/guardian and/or) who may be potential family participants: a) 
based on purposeful recruitment and the interest by potential participants a member of the 
tribal research team will schedule a time convenient for the potential family participants 
to meet at a designated place that will comfortably accommodate the potentional family 
and the research team member(s), the meeting room will be closed to the general public 
(e.g. family home or private work office)  to allow for privacy and confidentiality, during 
this meeting the potential family participants will be able to review the project documents 
that will be provided prior to consent; b) at the scheduled meeting time with the potential 
family participants, the tribal research team member will read aloud the consent and 
assent forms and will also provide a copy for the potential participants to follow along; c)  
next, a copy of the adult and child pre/post instruments will be provided to allow the 
potential family participants the opportunity to review and ask questions; d) an outline of 
the twelve weekly two-hour sessions of the prevention/intervention FL/CP program will 
be provided. The potential family participants will have time to read all the documents 
and to ask questions and consider participating. The potential family particpants will be 
informed of the voluntary nature of the study, as well as the potential risks and benefits 
and other information described in the consent and assest documents; and finally, e) for 
those that choose to participate they will sign their consent and assest forms which will 
be collected and placed in a sealed envelope. After receiving the signed informed consent 
the parent/caregiver will be given the adult pre-test instrument, which will be self- 
administered on the secure password protected laptop. A tribal and/or UNM research 
members will be available should clarification of a question be requested by the 
participant. The adult post-survey instrument will be self-administered upon the 
completion of the twelve weekly two-hour sessions of the family prevention/intervention 
curriculum by adult participants who voluntary to complete. Child pre-tests and post-tests 
will be administered at the schools or another tribal facility with either a tribal or UNM 
research team member, using the secure password protected laptops to assure 
confidentiality. Up to four children at a time can take the tests simultaneously. . 
 
Leaders, managers, educators, and/or staff. The following consent process will be 
conducted with the adult community leader, manager or staff who may be potential 
interview participants: a) based on purposeful recruitment and the interest of the potential 
participant, a tribal research team member will schedule a time convenient for the 

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potential interview participant to meet for the interview. The interview will be scheduled 
at a convenient location that will comfortably accommodate the potential participant and 
research team member. The interview location may be a private office space or other 
location to allow for privacy and confidentiality; b) at the scheduled meeting time with 
the interview participant, a tribal research team member will read aloud the consent form 
and will provide the interview participant with a copy to follow along. The interviewee 
will be informed of the voluntary nature of the study, as well as the potential risks and 
benefits and other information described in the consent document; c) after the consent 
form has been reviewed the potential participant will be asked if he/she has any 
questions. Questions will be answered and the interviewer will ask if the participant 
wishes to continue with the interview. If they decide not to participate the interviewer 
will thank the potential participant for his/her time and leave. If the potential participant 
wishes to proceed with the interview, the interviewer will ask the participant to sign the 
consent form, and place the signed consent form into an envelope and seal it. The 
potential family participants; and finally, d) lastly, the participant will be given a copy of 
the interview questions to follow along with the interviewer and the interview will 
commence. 
Waiver or Alteration of Informed Consent:   
Will not be requesting an alteration or waiver of informed consent.  
Waiver of Written Documentation of Consent:   
Not requesting a waiver of consent documentation.  
HIPAA Authorization 
No, will not be collecting PHI. 
Waiver of HIPAA authorization:    
No will not be requesting a waiver of HIPAA. 
Non-English Speaking Subjects 
English will be the primary language of the prospective participants.  
Planned Emergency Research Consents 
N/A  
Cognitively Impaired Adults/ Adults Unable to Consent/  Use of a Legally 
Authorized Representative (LAR) 
N/A 
 

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30) Drugs or Devices 
N/A 
Drugs:  Please respond to all questions in this section and include a 
completed and signed Drug Attachment form. 
 
Medical Devices:  Please respond to all questions in this section.  
N/A  
Please complete the section below to determine if an IDE is required:  
N/A  
 
Humanitarian Use Device (HUD):  
 
N/A