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Clinical Trials/NCT03145363
NCT03145363CompletedNot Applicable

Mobile Phone Intervention to Reduce Youth Suicide in Rural Communities

University of Rochester0 sites222 target enrollmentStarted: June 29, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
222
Primary Endpoint
Resources for Coping

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Masking Description

Participants do not know which group they were randomized into.

Eligibility Criteria

Ages
13 Years to 19 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Intervention

Experimental

receive interactive text messages

Intervention: Intervention (Behavioral)

Control

Active Comparator

Receive informational text messages

Intervention: Control (Behavioral)

Outcomes

Primary Outcomes

Resources for Coping

Time Frame: change from baseline to three-month follow-up

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

Emotion self-regulation skills

Time Frame: change from baseline to three-month follow-up

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

Help-Seeking norms

Time Frame: change from baseline to three-month follow-up

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

Secondary Outcomes

  • Suicidal Ideation(baseline, immediate follow-up, three-month follow-up)
  • Depression(baseline, immediate follow-up, three-month follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anthony Pisani

Associate Professor

University of Rochester

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