Mobile Phone Intervention to Reduce Youth Suicide in Rural Communities
2017年7月17日 更新者：Anthony Pisani、University of Rochester
The goal of this research project is to conduct a pilot RCT of Text4Strength, an interactive automated text messaging extension of Sources of Strength (SoS), a universal school-based suicide prevention program that prepares diverse 'key opinion leaders' to conduct public health messaging and activities with peers to increase school-wide positive coping norms, communication with trusted adults, and seeking help for suicidal peers (Wyman et al., 2010).
The investigators previously developed and field tested Text4Strength messages (RSRB#00047481 and 53924 closed) to demonstrate feasibility, safety, student engagement, and student-perceived relevance for a universal texting extension.
The investigators will now conduct a pilot randomized controlled trial in one large school in Western New York that has implemented Sources of Strength for the past two years.
The school will continue with Sources of Strength in the 2016-17 school, and add this school-wide texting component as part of this research study.
Consistent with Leon's guidelines on pilot studies, the primary focus will be to identify areas of promise, success in reaching proximate targets, and the need for additional modifications (Leon, Davis, & Kraemer, 2011).
Findings from this study will inform further refinement of the text messaging program and provide preliminary data for a larger efficacy trial.
研究概览
研究类型
介入性
注册 (实际的)
222
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
13年 至 19年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 9th-12th grade students in study school
- must have own cell phone
Exclusion Criteria:
- no cell phone
- not sufficiently English-speaking to complete surveys
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Intervention
receive interactive text messages
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The intervention group will receive 2-5 interactive text message sequences per week.
These messages will invite students to reply using keywords and short free text replies.
Messages come from a library of strength-based peer quotations (reviewed for safety), psychoeducational interactions, and games designed to promote emotional skills and use of resources.
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有源比较器：Control
Receive informational text messages
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The control group will receive 1-2 (non-interactive) text messages per week containing general SoS concepts (e.g., "Remember: more strengths are better when times get tough").
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Emotion self-regulation skills
大体时间：change from baseline to three-month follow-up
|
Difficulties with Emotion Regulation Scales (DERS) (Gratz & Roemer, 2004)
|
change from baseline to three-month follow-up
|
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Resources for Coping
大体时间：change from baseline to three-month follow-up
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uptake of Sources of Strength concepts (Wyman et al., 2010)
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change from baseline to three-month follow-up
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Help-Seeking norms
大体时间：change from baseline to three-month follow-up
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Help-seeking from adults at school (Schmeelk-Cone, et al, 2012)
|
change from baseline to three-month follow-up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Depression
大体时间：baseline, immediate follow-up, three-month follow-up
|
Mood and Feelings Questionnaire (MFQ: Angold, et al., 1996; Costello & Angold, 1988)
|
baseline, immediate follow-up, three-month follow-up
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Suicidal Ideation
大体时间：baseline, immediate follow-up, three-month follow-up
|
one question from the MFQ about suicidal ideation in the past two weeks
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baseline, immediate follow-up, three-month follow-up
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Anthony R Pisani, PhD、University of Rochester Medical Center, Psychiatry Dept
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Terwee CB, Roorda LD, de Vet HC, Dekker J, Westhovens R, van Leeuwen J, Cella D, Correia H, Arnold B, Perez B, Boers M. Dutch-Flemish translation of 17 item banks from the patient-reported outcomes measurement information system (PROMIS). Qual Life Res. 2014 Aug;23(6):1733-41. doi: 10.1007/s11136-013-0611-6. Epub 2014 Jan 9.
- Neacsiu AD, Rizvi SL, Vitaliano PP, Lynch TR, Linehan MM. The dialectical behavior therapy ways of coping checklist: development and psychometric properties. J Clin Psychol. 2010 Jun;66(6):563-82. doi: 10.1002/jclp.20685.
- Gould MS, Greenberg T, Munfakh JL, Kleinman M, Lubell K. Teenagers' attitudes about seeking help from telephone crisis services (hotlines). Suicide Life Threat Behav. 2006 Dec;36(6):601-13. doi: 10.1521/suli.2006.36.6.601.
- Hahn EA, DeWalt DA, Bode RK, Garcia SF, DeVellis RF, Correia H, Cella D; PROMIS Cooperative Group. New English and Spanish social health measures will facilitate evaluating health determinants. Health Psychol. 2014 May;33(5):490-9. doi: 10.1037/hea0000055. Epub 2014 Jan 20.
- Pisani AR, Wyman PA, Petrova M, Schmeelk-Cone K, Goldston DB, Xia Y, Gould MS. Emotion regulation difficulties, youth-adult relationships, and suicide attempts among high school students in underserved communities. J Youth Adolesc. 2013 Jun;42(6):807-20. doi: 10.1007/s10964-012-9884-2. Epub 2012 Dec 18.
- Schmeelk-Cone K, Pisani AR, Petrova M, Wyman PA. Three scales assessing high school students' attitudes and perceived norms about seeking adult help for distress and suicide concerns. Suicide Life Threat Behav. 2012 Apr;42(2):157-72. doi: 10.1111/j.1943-278X.2011.00079.x. Epub 2012 Feb 10.
- Simons, J. S., & Gaher, R. M. (2005). The Distress Tolerance Scale: Development and Validation of a Self-Report Measure. Motivation and Emotion, 29(2), 83-102. doi:10.1007/s11031-005-7955-3
- Wyman PA, Brown CH, LoMurray M, Schmeelk-Cone K, Petrova M, Yu Q, Walsh E, Tu X, Wang W. An outcome evaluation of the Sources of Strength suicide prevention program delivered by adolescent peer leaders in high schools. Am J Public Health. 2010 Sep;100(9):1653-61. doi: 10.2105/AJPH.2009.190025. Epub 2010 Jul 15.
- Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of Psychopathology and Behavioral Assessment, 26(1), 41-54. doi:10.1023/B:JOBA.0000007455.08539.94
- Angold, A., Costello, E. J., Messer, S., Pickles, A., Winder, F., & Silver, D. (1996). Development of a short questionnaire for use in epidemiological studies of depression in children and adolescents. International Journal of Methods in Psychiatric Research, 5, 237-249.
- Costello EJ, Angold A. Scales to assess child and adolescent depression: checklists, screens, and nets. J Am Acad Child Adolesc Psychiatry. 1988 Nov;27(6):726-37. doi: 10.1097/00004583-198811000-00011. No abstract available.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年6月29日
初级完成 (实际的)
2017年5月26日
研究完成 (实际的)
2017年5月26日
研究注册日期
首次提交
2017年4月25日
首先提交符合 QC 标准的
2017年5月4日
首次发布 (实际的)
2017年5月9日
研究记录更新
最后更新发布 (实际的)
2017年7月19日
上次提交的符合 QC 标准的更新
2017年7月17日
最后验证
2017年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Intervention的临床试验
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Ege Miray Topcu完全的
-
University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)尚未招聘
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University完全的
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人