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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
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Help-Seeking Behavior

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    April 25, 2017
    Last Updated
    July 17, 2017
    Sponsor
    University of Rochester
    Collaborators
    National Institute of Mental Health (NIMH)
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    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
    background
    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
    background
    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
    background

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    Mobile Phone Intervention to Reduce Youth Suicide in Rural Communities

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