跳至主要内容
临床试验/NCT03136094
NCT03136094招募中不适用

Collaborative Hub to Reduce the Burden of Suicide Among Urban American Indian and Alaska Native Young Adults

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 698 人开始时间: 2020年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
698
试验地点
1
主要终点
Change in Suicidal Ideation

研究概览

简要总结

This study compares the effectiveness of a program to detect and manage suicide risk among American-Indian and Alaska Native (AI/AN) youth. Half of the participants will receive caring text messages to reduce suicidal thoughts, attempts, and hospitalizations and to increase engagement, social connectedness, and resilience in at-risk youth. The other half will receive usual care that does not include the caring text messages.

详细描述

The study, "Suicide in Urban Natives: Detection and Networks to Combat Events," builds on Screening, Brief Intervention and Referral to treatment (SBIRT), carried out through the primary care setting, to detect and manage suicide risk. This approach is multilevel, targeting both the healthcare system and the individual, and links screening to existing mobile phone technologies shown to promote resilience and to tap the protective benefits of social connectedness. This Collaborative Hub will conduct a randomized control trial that compares the effectiveness of enhancing these SBIRT programs by sending caring text messages to reduce suicidal ideation, attempts, and hospitalizations, and to increase engagement, social connectedness, and resilience. The Investigators' long-term goal is to disseminate and translate the lessons learned into practical policy, organizational changes, and preventive innovations that optimize patient-centered health outcomes and ultimately reduce or eliminate the dramatic and tragic suicide-related health disparities among urban AI/AN youth and young adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Patients will not be given details about how text messaging differs for the 2 study groups. Instead, patients will be told that the clinic is testing a program to support people who are having hard times, and that they will receive periodic text messages from the Site Coordinator for the next 12 months.

入排标准

年龄范围
18 Years 至 34 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Self-identify as American Indian or Alaska Native;
  • •Screen positive for mild, moderate, or severe risk of suicidality (referred by a clinical provider);
  • •Have a text-enabled mobile phone;
  • •Willing to be contacted by text;
  • •Able to participate voluntarily;
  • •Speak and read English;
  • •Cognitively able to independently provide written informed consent

排除标准

  • •Under age 18
  • •In danger of imminent self-harm;
  • •Hospitalized

研究组 & 干预措施

SBIRT+Usual Care

Placebo Comparator

The control arm of the trial will receive the usual care prescribed in the Screening, Brief Intervention and Referral to Treatment (SBIRT) model.

干预措施: SBIRT+Usual Care (Behavioral)

SBIRT+12

Experimental

The standard SBIRT model is augmented by a 12 month period following identification of suicide risk during which participants will receive caring text messages adapted from empirically-based, effective interventions for suicide prevention among American Indian and Alaska Native young adults.

干预措施: SBIRT+12 (Behavioral)

结局指标

主要结局

Change in Suicidal Ideation

时间窗: Baseline, 6 months, 12 months

The 15-item Suicidal Ideation Questionnaire Jr. assesses frequency of suicidal thoughts in the past month. Item content ranges from general thoughts of death and wishes that one were dead to specific thoughts of self-injurious behavior. Responses are on a 7-point scale ranging from never to almost daily. Items are summed for a total score (range 0-90).

Change in Self-Reported Suicide Attempts

时间窗: Baseline, 6 months, 12 months

The investigators will use the interviewer-administered Suicide Attempt and Self-Injury Count to assess the method, intent, treatment received, and lethality for all suicide attempts over the respondent's lifetime.

Change in Hospitalizations and Behavioral Health Treatment

时间窗: Baseline, 6 months, 12 months

The investigators will assess self-reported hospitalizations over the previous 12 months with a measure of health service use previously applied to AI/ANs. It captures information on inpatient and outpatient medical care, emergency room visits, and use of traditional practices.

次要结局

  • Change in Social Connectedness(Baseline, 6 months, 12 months)
  • SBIRT Retention and Uptake of Referral to Therapy(6 months, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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