"Keep up the messages, sometimes it was a lifesaver": Effects of cultural adaptation on a suicide prevention clinical trial in American Indian/Alaska Native communities.

Suicide disproportionately affects many American Indian/Alaska Native (AI/AN) communities. Caring Contacts is one of the few suicide prevention interventions with demonstrated success in diverse populations, but its acceptability and effectiveness have not been evaluated in AI/AN communities. Using community-based participatory research (Phase 1), we conducted focus groups and semi-structured interviews with AI/AN adults, healthcare providers, and leaders in four communities to improve study design and maximize intervention acceptability and effectiveness for implementation in a randomized controlled trial (Phase 2). This paper describes how adaptations made during Phase 1 affected the acceptability, fit, and responsiveness of the study features to the communities' needs. Acceptability of the study procedures and materials in this community appears to be high, with 92% of participants indicating the initial assessment interview was a positive experience. Broadening eligibility criteria with regard to age and possession of a cellular device resulted in the recruitment of an additional 48% and 46% of participants, respectively. Inclusion of locally-informed methods of self-harm allowed us to capture a wider range of suicidal behavior than would have otherwise been identified. Clinical trials would benefit from community-engaged, cultural adaptation studies with populations in which the interventions would eventually be applied.

Implementation fidelity of the Promoting First Relationships intervention program in a Native community.

Promoting First Relationship (PFR) is an evidence-based intervention designed to promote positive, supportive relationships between primary caregivers and their young children. Implementing and testing the efficacy of PFR in a remote Native community is especially challenging and requires methods and tools for ensuring implementation fidelity. Tribal members of a Native community were successfully trained and certified to deliver PFR by university-based personnel. During PFR delivery, they achieved very high scores on adherence to intervention content (M = 0.99, SD = 0.02), and their quality of delivery uniformly exceeded established criteria. High attrition occurred before PFR was delivered. However, participants who remained in the study completed all 10 sessions of PFR content. Participants' satisfaction with the program was very high (M = 3.90 [of 4 points], SD = 0.19). High implementation fidelity was attained in the face of many inherent challenges. The suite of methods and tools used for training, monitoring, and evaluating implementation fidelity in this study provides an example that may be useful in the evaluation of evidence-based programs more generally.

Caring Texts, a strength-based, suicide prevention trial in 5 native communities: Research design and methods.

BACKGROUND: Despite their intrinsic strengths and resilience, some American Indian and Alaska Native (AI/AN) communities experience among the highest rates of suicide of any racial and ethnic group. Caring Contacts is one of the only interventions shown to reduce suicide in clinical trials, but it has not been tested in AI/AN settings. OBJECTIVE: To compare the effectiveness of Enhanced Usual Care (control) to Enhanced Usual Care augmented with a culturally adapted version of Caring Contacts (intervention) for reducing suicidal ideation, suicide attempts, and suicide-related hospitalizations. METHODS: We are implementing a single blind randomized controlled trial of Caring Contacts in five AI/AN communities across the country (South Dakota, Montana, Oklahoma, and Alaska). Eligible participants have to be (1) actively suicidal or have made a suicide attempt within the past year; (2) at least 18 years of age; (3) AI/AN; (4) able to speak and read English; (5) able to participate voluntarily; (6) willing to be contacted by text, email or postal mail; and (7) able to provide consent. Following consent and baseline assessment, participants are randomized to receive either Enhanced Usual Care alone, or Enhanced Usual Care with 12 months (25 messages) of culturally adapted Caring Contacts. Follow-up assessments are conducted at 12 and 18 months. CONCLUSIONS: If effective, this study of Caring Contacts will inform programs to reduce suicide in the study communities as well as inform future research on Caring Contacts in other tribal settings. Modifications to continue the trial during the COVID-19 pandemic are discussed. CLINICAL TRIALS REGISTRATION: NCT02825771.

Disparities in Access to Radiation Therapy by Race and Ethnicity in the United States With Focus on American Indian/Alaska Native People.

OBJECTIVES: Striking disparities in access to radiation therapy (RT) exist, especially among racial and ethnic-minority patients. We analyzed census block group data to evaluate differences in travel distance to RT as a function of race and ethnicity, socioeconomic status, and rurality. METHODS: The Directory of Radiotherapy Centers provided the addresses of facilities containing linear accelerators for RT. We classified block groups as majority (≥ 50%) American Indian/Alaska Native (AI/AN), black, white, Asian, no single racial majority, or Hispanic regardless of race. We used the Area Deprivation Index to classify deprivation and Rural-Urban Commuting Area codes to classify rurality. Generalized linear mixed models tested associations between these factors and distance to nearest RT facility. RESULTS: Median distance to nearest RT facility was 72 miles in AI/AN-majority block groups, but 4 to 7 miles in block groups with non-AI/AN majorities. Multivariable models estimated that travel distances in AI/AN-majority block groups were 39 to 41 miles longer than in areas with non-AI/AN majorities. Travel distance was 1.3 miles longer in the more deprived areas versus less deprived areas and 16 to 32 miles longer in micropolitan, small town, and rural areas versus metropolitan areas. CONCLUSIONS: Cancer patients in block groups with AI/AN-majority populations, nonmetropolitan location, and low socioeconomic status experience substantial travel disparities in access to RT. Future research with more granular community- and individual-level data should explore the many other known barriers to access to cancer care and their relationship to the barriers posed by distance to RT care.

Promoting First Relationships®: Implementing a Home Visiting Research Program in Two American Indian Communities.

BACKGROUND: Few, if any, home visiting programs for children under the age of three have been culturally adapted for American Indian reservation settings. We recently adapted one such program: Promoting First Relationships®. OBJECTIVES: To culturally adapt Promoting First Relationships® while maintaining program fidelity, we used a community-based participatory approach to elicit input from two American Indian partners. METHODS: University-based researchers, reservation-based Native project staff, and Native tribal liaisons conducted collaborative meetings, conference calls, and focus groups to adapt Promoting First Relationships® to reflect local community needs and values. LESSONS LEARNED: Working closely with onsite Native project staff, being flexible and open to suggestions, and attending to the logistical needs of the community are imperative to developing and implementing adaptations. CONCLUSIONS: Several adaptations were made based on the collaboration between researchers and Native project staff. Collaboration is critical for adapting programs so they can be tested in ways that respect both American Indian culture and research needs.

Resolution of depression and grief during the first year after miscarriage: a randomized controlled clinical trial of couples-focused interventions.

AIMS: The purpose of this randomized controlled clinical trial was to examine the effects of three couples-focused interventions and a control condition on women and men's resolution of depression and grief during the first year after miscarriage. METHODS: Three hundred forty-one couples were randomly assigned to nurse caring (NC) (three counseling sessions), self-caring (SC) (three video and workbook modules), combined caring (CC) (one counseling session plus three SC modules), or control (no treatment). Interventions, based on Swanson's Caring Theory and Meaning of Miscarriage Model, were offered 1, 5, and 11 weeks after enrollment. Outcomes included depression (CES-D) and grief, pure grief (PG) and grief-related emotions (GRE). Differences in rates of recovery were estimated via multilevel modeling conducted in a Bayesian framework. RESULTS: Bayesian odds (BO) ranging from 3.0 to 7.9 favored NC over all other conditions for accelerating women's resolution of depression. BO of 3.2-6.6 favored NC and no treatment over SC and CC for resolving men's depression. BO of 3.1-7.0 favored all three interventions over no treatment for accelerating women's PG resolution, and BO of 18.7-22.6 favored NC and CC over SC or no treatment for resolving men's PG. BO ranging from 2.4 to 6.1 favored NC and SC over CC or no treatment for hastening women's resolution of GRE. BO from 3.5 to 17.9 favored NC, CC, and control over SC for resolving men's GRE. CONCLUSIONS: NC had the overall broadest positive impact on couples' resolution of grief and depression. In addition, grief resolution (PG and GRE) was accelerated by SC for women and CC for men.