NCT03145363

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2017

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

April 25, 2017

Last Update Submit

July 17, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • Emotion self-regulation skills

    Difficulties with Emotion Regulation Scales (DERS) (Gratz \& Roemer, 2004)

    change from baseline to three-month follow-up

  • Resources for Coping

    uptake of Sources of Strength concepts (Wyman et al., 2010)

    change from baseline to three-month follow-up

  • Help-Seeking norms

    Help-seeking from adults at school (Schmeelk-Cone, et al, 2012)

    change from baseline to three-month follow-up

Secondary Outcomes (2)

  • Depression

    baseline, immediate follow-up, three-month follow-up

  • Suicidal Ideation

    baseline, immediate follow-up, three-month follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

receive interactive text messages

Behavioral: Intervention

Control

ACTIVE COMPARATOR

Receive informational text messages

Behavioral: Control

Interventions

InterventionBEHAVIORAL

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
ControlBEHAVIORAL

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").

Control

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • th-12th grade students in study school
  • must have own cell phone

You may not qualify if:

  • no cell phone
  • not sufficiently English-speaking to complete surveys

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • 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.

    PMID: 17250466BACKGROUND
  • 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.

    PMID: 24447188BACKGROUND
  • 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.

    PMID: 20455249BACKGROUND
  • 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.

    PMID: 23666604BACKGROUND
  • 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.

    PMID: 22324773BACKGROUND
  • 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

    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.

    PMID: 24402179BACKGROUND
  • 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.

    PMID: 20634440BACKGROUND
  • 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

    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.

    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.

    PMID: 3058677BACKGROUND
  • 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.

MeSH Terms

Conditions

Help-Seeking BehaviorSuicide

Interventions

Methods

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorSelf-Injurious BehaviorBehavioral Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Anthony R Pisani, PhD

    University of Rochester Medical Center, Psychiatry Dept

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants do not know which group they were randomized into.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Intervention group (receives interactive text messages) and control group (receives informative text messages)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 25, 2017

First Posted

May 9, 2017

Study Start

June 29, 2016

Primary Completion

May 26, 2017

Study Completion

May 26, 2017

Last Updated

July 19, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share