Mobile Phone Intervention to Reduce Youth Suicide in Rural Communities

NCT ID: NCT03145363

Last Updated: 2017-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-29

Study Completion Date

2017-05-26

Brief Summary

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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.

Detailed Description

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Conditions

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Help-Seeking Behavior Emotions Trusted Adults Suicide Positive Affect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention group (receives interactive text messages) and control group (receives informative text messages)
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Participants do not know which group they were randomized into.

Study Groups

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Intervention

receive interactive text messages

Group Type EXPERIMENTAL

Intervention

Intervention Type BEHAVIORAL

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.

Control

Receive informational text messages

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

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").

Interventions

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Intervention

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

Control

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").

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Anthony Pisani

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anthony R Pisani, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester Medical Center, Psychiatry Dept

References

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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.

Reference Type BACKGROUND
PMID: 17250466 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24447188 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20455249 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23666604 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22324773 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 24402179 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20634440 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 3058677 (View on PubMed)

Pisani AR, Wyman PA, Cero I, Kelberman C, Gurditta K, Judd E, Schmeelk-Cone K, Mohr D, Goldston D, Ertefaie A. Text Messaging to Extend School-Based Suicide Prevention: Pilot Randomized Controlled Trial. JMIR Ment Health. 2024 Dec 6;11:e56407. doi: 10.2196/56407.

Reference Type DERIVED
PMID: 39642360 (View on PubMed)

Other Identifiers

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K23MH101449

Identifier Type: NIH

Identifier Source: org_study_id

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