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Mobile Phone Intervention to Reduce Youth Suicide in Rural Communities

Sponsor
University of Rochester (Other)
Overall Status
Completed
CT.gov ID
NCT03145363
Collaborator
National Institute of Mental Health (NIMH) (NIH)
222
Enrollment
2
Arms
10.9
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intervention
  • Behavioral: Control
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
222 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Intervention group (receives interactive text messages) and control group (receives informative text messages)Intervention group (receives interactive text messages) and control group (receives informative text messages)
Masking:
Single (Participant)
Masking Description:
Participants do not know which group they were randomized into.
Primary Purpose:
Prevention
Official Title:
Mobile Phone Intervention to Reduce Youth Suicide in Rural Communities
Actual Study Start Date :
Jun 29, 2016
Actual Primary Completion Date :
May 26, 2017
Actual Study Completion Date :
May 26, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

receive interactive text messages

Behavioral: 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.
Active Comparator: Control

Receive informational text messages

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").

Outcome Measures

Primary Outcome Measures

  1. Emotion self-regulation skills [change from baseline to three-month follow-up]

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

  2. Resources for Coping [change from baseline to three-month follow-up]

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

  3. Help-Seeking norms [change from baseline to three-month follow-up]

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

Secondary Outcome Measures

  1. Depression [baseline, immediate follow-up, three-month follow-up]

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

  2. Suicidal Ideation [baseline, immediate follow-up, three-month follow-up]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 19 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Rochester
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Anthony R Pisani, PhD, University of Rochester Medical Center, Psychiatry Dept

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Anthony Pisani, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier:
NCT03145363
Other Study ID Numbers:
  • K23MH101449
First Posted:
May 9, 2017
Last Update Posted:
Jul 19, 2017
Last Verified:
Jul 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Suicide

Study Results

No Results Posted as of Jul 19, 2017