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Help-Seeking BehaviorNCT03145363

Mobile Phone Intervention to Reduce Youth Suicide in Rural Communities

A study testing Intervention in people with Help-Seeking Behavior and Emotions, run by University of Rochester.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 13 to 19 yearsHealthy volunteers can take part
Conditions the study is for
Help-Seeking Behavior, Emotions, Trusted Adults
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
222 participants
Where
No sites listed yet
Study dates
29 Jun 2016to 26 May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 9th-12th grade students in study school
  • must have own cell phone

Who cannot join

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

About this study

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.

Being tested
Intervention, Control
Medical subject headings
Help-Seeking Behavior, Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterventionBehavioural

    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.

  • ControlBehavioural

    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").

Study groups in NCT03145363
Study groupRoleWhat they receive
InterventionExperimentalreceive interactive text messages
Receives: Behavioral: Intervention
ControlActive comparatorReceive informational text messages
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Emotion self-regulation skills

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

    Measured: change from baseline to three-month follow-up

  2. Resources for Coping

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

    Measured: change from baseline to three-month follow-up

  3. Help-Seeking norms

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

    Measured: change from baseline to three-month follow-up

Secondary outcomes (2)

  1. Depression

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

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

  2. Suicidal Ideation

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2017
  2. Study start29 Jun 2016
  3. Primary completion26 May 2017
  4. Study completion26 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Intervention group (receives interactive text messages) and control group (receives informative text messages)
Masking
Single blind
Who is masked
Participant
Enrolment
222 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03145363
Sponsor's protocol ID
K23MH101449
Status last verified
Jul 2017
First submitted
25 Apr 2017
Last updated
19 Jul 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17250466

  • 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.

    PubMed 24447188

  • 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.

    PubMed 20455249

  • 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.

    PubMed 23666604

  • 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.

    PubMed 22324773

  • 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

  • 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.

    PubMed 24402179

  • 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.

    PubMed 20634440

  • 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

  • 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.

  • 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.

    PubMed 3058677

  • 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.

    PubMed 39642360

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Help-Seeking Behavior and Emotions, run by University of Rochester.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emotion self-regulation skills (time frame: change from baseline to three-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03145363, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.

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