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OpenTrials
Completed

NCT Number: NCT03145363

Mobile Phone Intervention to Reduce Youth Suicide in Rural Communities

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.

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Key information

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

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

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").

Primary outcomes

  1. Emotion self-regulation skills

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

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

  2. Resources for Coping

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

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

  3. 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

  1. Depression

    Time frame: baseline, immediate follow-up, three-month follow-up

    Mood and Feelings Questionnaire (MFQ: Angold, et al., 1996; Costello & Angold, 1988)

  2. Suicidal Ideation

    Time frame: baseline, immediate follow-up, three-month follow-up

    one question from the MFQ about suicidal ideation in the past two weeks

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 9, 2017
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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