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Employing a sequential multiple assignment randomized trial (SMART) to evaluate the impact of brief risk and protective factor prevention interventions for American Indian Youth Suicide.

ABSTRACT: BACKGROUND:This study is built on a long-standing research partnership between the Johns Hopkins Center for American Indian Health and the White Mountain Apache Tribe to identify effective interventions to prevent suicide and promote resilience among American Indian (AI) youth. The work is founded on a tribally-mandated, community-based suicide surveillance system with case management by local community mental health specialists (CMHSs) who strive to connect at-risk youth to treatment and brief, adjunctive interventions piloted in past research. METHODS:Our primary aim is to evaluate which brief interventions, alone or in combination, have the greater effect on suicide ideation (primary outcome) and resilience (secondary outcome) among AI youth ages 10-24 ascertained for suicide-related behaviors by the tribal surveillance system. We are using a Sequential Multiple Assignment Randomized Trial with stratified assignment based on age and suicidal-behavior type, and randomizing N?= 304 youth. Brief interventions are delivered by AI CMHSs, or by Elders with CMHS support, and include: 1) New Hope, an evidence-based intervention to reduce immediate suicide risk through safety planning, emotion regulation skills, and facilitated care connections; and 2) Elders' Resilience, a culturally-grounded intervention to promote resilience through connectedness, self-esteem and cultural identity/values. The control condition is Optimized Case Management, which all study participants receive. We hypothesize that youth who receive: a) New Hope vs. Optimized Case Management will have significant reductions in suicide ideation; b) Elders' Resilience vs. Optimized Case Management will have significant gains in resilience; c) New Hope followed by Elders' Resilience will have the largest improvements on suicide ideation and resilience; and d) Optimized Case Management will have the weakest effects of all groups. Our secondary aim will examine mediators and moderators of treatment effectiveness and sequencing. DISCUSSION:Due to heterogeneity of suicide risk/protective factors among AI youth, not all youth require the same types of interventions. Generating evidence for what works, when it works, and for whom is paramount to AI youth suicide prevention efforts, where rates are currently high and resources are limited. Employing Native paraprofessionals is a means of task-shifting psychoeducation, culturally competent patient support and continuity of care. TRIAL REGISTRATION:Clinical Trials NCT03543865, June 1, 2018.

SUBMITTER: O'Keefe VM

PROVIDER: S-EPMC6909588 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Employing a sequential multiple assignment randomized trial (SMART) to evaluate the impact of brief risk and protective factor prevention interventions for American Indian Youth Suicide.

O'Keefe Victoria M VM Haroz Emily E EE Goklish Novalene N Ivanich Jerreed J Cwik Mary F MF Barlow Allison A

BMC public health 20191212 1

<h4>Background</h4>This study is built on a long-standing research partnership between the Johns Hopkins Center for American Indian Health and the White Mountain Apache Tribe to identify effective interventions to prevent suicide and promote resilience among American Indian (AI) youth. The work is founded on a tribally-mandated, community-based suicide surveillance system with case management by local community mental health specialists (CMHSs) who strive to connect at-risk youth to treatment an ...[more]

PMID: 31830933

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Project description:IntroductionThe postdischarge suicide risk among psychiatric patients is significantly higher than it is among patients with other diseases and general population. The brief contact interventions (BCIs) are recommended to decrease suicide risk in areas with limited mental health service resources like China. This study aims to develop a postdischarge suicide intervention strategy based on BCIs and evaluate its implementability under the implementation outcome framework.Methods and analysisThis study will invite psychiatric patients and family members, clinical and community mental health service providers as the community team to develop a postdischarge suicide intervention strategy. The study will recruit 312 patients with psychotic symptoms and 312 patients with major depressive disorder discharged from Shenzhen Kangning Hospital (SKH) in a Sequential Multiple Assignment Randomised Trial. Participants will be initially randomised into two intervention groups to receive BCIs monthly and weekly, and they will be rerandomised into three intervention groups to receive BCIs monthly, biweekly and weekly at 3 months after discharge according to the change of their suicide risk. Follow-ups are scheduled at 1, 3, 6 and 12 months after discharge. With the intention-to-treat approach, generalised estimating equation and survival analysis will be applied. This study will also collect qualitative and quantitative information on implementation and service outcomes from the community team.Ethics/disseminationThis study has received ethical approval from the Ethics Committee Review Board of SKH. All participants will provide written informed consent prior to enrolment. The findings of the study will be disseminated through peer-reviewed scientific journals, conference presentations. A project report will be submitted to the National Natural Science Foundation of China as the concluding report of this funded project, and to the mental health authorities in the Shenzhen to refine and apply evidence-based and pragmatic interventions into health systems for postdischarge suicide prevention.Trial registration numberNCT04907669.

Project description:BACKGROUND:Youth living with HIV (YLH) aged 13 to 24 years made up over a fifth (21%) of new HIV diagnoses in 2016, yet only 27% of YLH are virally suppressed. YLH have been shown to be poorly adherent to antiretroviral therapy (ART); however, there has been limited research investigating how to increase adherence in YLH. Mobile health (mHealth) interventions may be one promising way to do this. OBJECTIVE:This study (ATN [Adolescent Trials Network] 144 SMART) aimed to compare adaptive interventions that could increase ART adherence in YLH aged 15 to 24 years. This includes mHealth initiatives, the tapering of interventions, and the use of incentives. Cost-effectiveness of sequencing the interventions without incentives before providing incentives and the savings on societal costs due to suppressed viral loads will be determined. This protocol is part of the ATN Scale It Up program described in this issue by Naar et al. METHODS:This study uses a Sequential Multiple Assignment Randomized Trial design. Approximately 190 participants are being recruited, enrolled, and randomized to either cell phone support or text message support. Both intervention groups receive 3 months of intervention, followed by a second randomization based on response to the intervention. Responders test tapering their intervention, and nonresponders test receiving incentives. RESULTS:Data collection for this study is projected to begin in August 2018 and last until June 2020. CONCLUSIONS:This is an innovative study, particularly in terms of population, intervention types, focus on cost-effectiveness, and recruitment. This study could be particularly effective in improving adherence in YLH while reducing long-term individual and societal costs. TRIAL REGISTRATION:ClinicalTrials.gov NCT03535337; https://clinicaltrials.gov/ct2/show/NCT03535337 (Archived by WebCite at http://www.webcitation.org/74alXb92z). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/11183.

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Employing a sequential multiple assignment randomized trial (SMART) to evaluate the impact of brief risk and protective factor prevention interventions for American Indian Youth Suicide.

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Employing a sequential multiple assignment randomized trial (SMART) to evaluate the impact of brief risk and protective factor prevention interventions for American Indian Youth Suicide.

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