Text-based Support for Suicide Prevention

(TESP Trial)

Recruiting at 1 trial location

Overseen By Ewa Czyz, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Medically unstable, Severe cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

420 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the text-based intervention treatment for suicide prevention?

Research shows that text messaging outreach after a suicide attempt is technically feasible and accepted by patients, who found it to have a positive preventive impact. Additionally, technology-enhanced interventions, including text messaging, have demonstrated effectiveness in reducing suicidal thoughts and improving mental health. ^{1 2 3 4 5}

Is text-based support for suicide prevention safe for humans?

Text-based support for suicide prevention, like smartphone apps and text messaging, has been found to be generally safe and well-received by users. Studies show high satisfaction and acceptability, with no specific safety concerns reported. ^{1 6 7 8 9}

How does the text-based intervention treatment for suicide prevention differ from other treatments?

The text-based intervention for suicide prevention is unique because it uses personalized text messages to support individuals, allowing them to create and access their own self-efficacy messages during times of crisis. This approach is distinct from traditional methods as it emphasizes individualization and user involvement in the design process, making it a flexible and low-cost alternative to other contact-based interventions. ^{1 3 4 7 10}

What is the purpose of this trial?

The goal of this study is to determine the effectiveness of an adaptive text-based intervention for parents of adolescents seeking emergency department services for suicide risk concerns.

Research Team

Ewa Czyz, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for parents of adolescents aged 13-17 who have visited the emergency department due to recent suicidal thoughts or attempts. The adolescent must be accompanied by a legal guardian, stable enough medically, and not severely cognitively impaired or aggressive.

Inclusion Criteria

I am a teenager who recently thought about or attempted suicide and I have a caregiver.

Exclusion Criteria

Adolescents presenting without a legal guardian

My parent does not own a cell phone.

I am a teenager and my health is currently unstable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Parents receive up to 3 text messages per day over six weeks after ED discharge, including an embedded micro-randomized trial component

6 weeks

Daily virtual interactions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Text-based intervention

Trial Overview The study is testing an adaptive text-based support system aimed at helping parents manage after their teen has been in the ED for suicide risk. It's designed to see if texts can effectively provide guidance and support.

Participant Groups

Group I: Standard ED care with a text-based intervention Experimental Treatment 1 Intervention

This arm incorporates adolescent-centered (A-C) and parent-centered (P-C) texting components Parents in the intervention arm will receive up to 3 text messages per day over six weeks after ED discharge: daily A-C text and up to two P-C messages. The P-C component includes an embedded micro-randomized trial (MRT), and parents will be randomized twice each day over the six-week intervention to either receive or not receive a P-C message.

Group II: Standard ED care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

A pilot study involving 18 post-suicidal patients demonstrated that text messaging outreach is technically feasible and was well-accepted by participants, who reported a positive impact on their recovery.

Text messaging offers a cost-effective and convenient alternative to traditional post-acute care strategies, suggesting potential for broader implementation and the need for further research to evaluate its efficacy in preventing post-acute suicidal behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-acute crisis text messaging outreach for suicide prevention: a pilot study. Berrouiguet, S., Gravey, M., Le Galudec, M., et al.[2018]

The Virtual Hope Box (VHB) app was found to be more regularly used and preferred by high-risk patients and their clinicians compared to a traditional hope box, indicating its potential effectiveness in helping patients cope with negative thoughts and stress.

Patients reported that the VHB was beneficial, easy to set up, and expressed a strong likelihood of continued use and recommendation to others, suggesting its practicality as a therapeutic tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Virtual Hope Box smartphone app as an accessory to therapy: proof-of-concept in a clinical sample of veterans. Bush, NE., Dobscha, SK., Crumpton, R., et al.[2022]

The pilot phase of the SmartCrisis 2.0 trial demonstrated that a smartphone-based safety plan for patients with recent suicidal behavior is feasible and well-accepted, with a participation rate of 77% and high satisfaction ratings (overall satisfaction score of 9.6 out of 10).

Patients found the safety plan useful (7.4/10) and easy to use (8.9/10), with common coping strategies including walking and exercise, indicating that the app could be a valuable tool in clinical practice for supporting mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based safety plan for suicidal crisis: The SmartCrisis 2.0 pilot study. Porras-Segovia, A., De Granda-Beltrán, AM., Gallardo, C., et al.[2023]

An automated, self-guided Internet-based safety plan (IBSP) was developed and evaluated by 150 participants who reported suicidality, showing moderate perceived utility among users.

Participants generally believed the IBSP could be more helpful for others than for themselves, indicating a potential gap in personal recognition of its benefits, and males were less likely to complete the safety plan steps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived Utility of the Internet-Based Safety Plan in a Sample of Internet Users Screening Positive for Suicidality. Spangler, DA., Muñoz, RF., Chu, J., et al.[2022]

A qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

A pilot study of a text-messaging intervention for youths discharged from the hospital after suicidal thoughts showed it was feasible and well-received, helping to reduce suicidal thoughts and behaviors.

The positive results of this intervention led to the Maryland Department of Health expanding the program to offer similar support to all Maryland residents, highlighting its potential effectiveness in suicide prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Text-Messaging Intervention for Suicidal Youths After Emergency Department Discharge. Ryan, TC., Chambers, S., Gravey, M., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of helping suicidal people using text messaging: An evaluation of effects and best practices of the Canadian suicide prevention Service's text helpline. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Post-acute crisis text messaging outreach for suicide prevention: a pilot study. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Information and communication technology-based interventions for suicide prevention implemented in clinical settings: a scoping review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Technology-enhanced suicide prevention interventions: A systematic review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A Virtual Hope Box smartphone app as an accessory to therapy: proof-of-concept in a clinical sample of veterans. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Smartphone-based safety plan for suicidal crisis: The SmartCrisis 2.0 pilot study. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Perceived Utility of the Internet-Based Safety Plan in a Sample of Internet Users Screening Positive for Suicidality. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A Brief Text-Messaging Intervention for Suicidal Youths After Emergency Department Discharge. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Involving service users in intervention design: a participatory approach to developing a text-messaging intervention to reduce repetition of self-harm. [2022]