Clinical trial NCT03145363: Mobile Phone Intervention to Reduce Youth Suicide in Rural Communities
Official title: Mobile Phone Intervention to Reduce Youth Suicide in Rural Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Help-Seeking Behavior
Emotions
Trusted Adults
Suicide
Positive Affect
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-05-09
Enrollment: 222
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group (receives interactive text messages) and control group (receives informative text messages)
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Emotion self-regulation skills
timeFrame: change from baseline to three-month follow-up
measure: Resources for Coping
timeFrame: change from baseline to three-month follow-up
measure: Help-Seeking norms
timeFrame: change from baseline to three-month follow-up
Secondary outcomes:
measure: Depression
timeFrame: baseline, immediate follow-up, three-month follow-up
measure: Suicidal Ideation
timeFrame: baseline, immediate follow-up, three-month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: University of Rochester Medical Center, Psychiatry Dept
name: Anthony R Pisani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
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citation: 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.
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