Mobile Phone Intervention to Reduce Youth Suicide in Rural Communities
Primary Purpose
Help-Seeking Behavior, Emotions, Trusted Adults
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention
Control
Sponsored by
About this trial
This is an interventional prevention trial for Help-Seeking Behavior
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
receive interactive text messages
Receive informational text messages
Outcomes
Primary Outcome Measures
Emotion self-regulation skills
Difficulties with Emotion Regulation Scales (DERS) (Gratz & Roemer, 2004)
Resources for Coping
uptake of Sources of Strength concepts (Wyman et al., 2010)
Help-Seeking norms
Help-seeking from adults at school (Schmeelk-Cone, et al, 2012)
Secondary Outcome Measures
Depression
Mood and Feelings Questionnaire (MFQ: Angold, et al., 1996; Costello & Angold, 1988)
Suicidal Ideation
one question from the MFQ about suicidal ideation in the past two weeks
Full Information
NCT ID
NCT03145363
First Posted
April 25, 2017
Last Updated
July 17, 2017
Sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03145363
Brief Title
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 29, 2016 (Actual)
Primary Completion Date
May 26, 2017 (Actual)
Study Completion Date
May 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Help-Seeking Behavior, Emotions, Trusted Adults, Suicide, Positive Affect
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention group (receives interactive text messages) and control group (receives informative text messages)
Masking
Participant
Masking Description
Participants do not know which group they were randomized into.
Allocation
Randomized
Enrollment
222 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
receive interactive text messages
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Receive informational text messages
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
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").
Primary Outcome Measure Information:
Title
Emotion self-regulation skills
Description
Difficulties with Emotion Regulation Scales (DERS) (Gratz & Roemer, 2004)
Time Frame
change from baseline to three-month follow-up
Title
Resources for Coping
Description
uptake of Sources of Strength concepts (Wyman et al., 2010)
Time Frame
change from baseline to three-month follow-up
Title
Help-Seeking norms
Description
Help-seeking from adults at school (Schmeelk-Cone, et al, 2012)
Time Frame
change from baseline to three-month follow-up
Secondary Outcome Measure Information:
Title
Depression
Description
Mood and Feelings Questionnaire (MFQ: Angold, et al., 1996; Costello & Angold, 1988)
Time Frame
baseline, immediate follow-up, three-month follow-up
Title
Suicidal Ideation
Description
one question from the MFQ about suicidal ideation in the past two weeks
Time Frame
baseline, immediate follow-up, three-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony R Pisani, PhD
Organizational Affiliation
University of Rochester Medical Center, Psychiatry Dept
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17250466
Citation
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.
Results Reference
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PubMed Identifier
24447188
Citation
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.
Results Reference
background
PubMed Identifier
20455249
Citation
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.
Results Reference
background
PubMed Identifier
23666604
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.
Results Reference
background
PubMed Identifier
22324773
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.
Results Reference
background
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
Results Reference
background
PubMed Identifier
24402179
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.
Results Reference
background
PubMed Identifier
20634440
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.
Results Reference
background
Citation
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
Results Reference
background
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.
Results Reference
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PubMed Identifier
3058677
Citation
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.
Results Reference
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Mobile Phone Intervention to Reduce Youth Suicide in Rural Communities
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