Combined for Suicide and Self-Harm

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Ronald Reagan Medical Center, Los Angeles, CASuicide and Self-HarmSAFETY-A within usual ED Care - Behavioral
Eligibility
15 - 24
All Sexes
What conditions do you have?
Select

Study Summary

This trialwill compare 2 treatments for suicidal youth in the ED. Outcomes monitored at 3, 6 & 12 months.

Eligible Conditions
  • Suicide and Self-Harm

Treatment Effectiveness

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Through 12 months of follow-up

Month 12
Quality of life and functioning: Clinical
Month 12
Mental Health Treatment Initiation: Primary Service Use Outcome
Ordinal suicidality scale: Clinical
Self-Harm: Secondary Clinical Outcome
Suicide
Treatment engagement: Secondary Service Use Outcome

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Combined
1 of 2
SAFETY-Acute within Usual ED Care
1 of 2

Active Control

1516 Total Participants · 2 Treatment Groups

Primary Treatment: Combined · No Placebo Group · Phase 2

Combined
Behavioral
ActiveComparator Group · 1 Intervention: Combined SAFETY-A within usual ED Care + CLASP Therapeutic Follow-Up Contacts · Intervention Types: Behavioral
SAFETY-Acute within Usual ED Care
Behavioral
ActiveComparator Group · 1 Intervention: SAFETY-A within usual ED Care · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through 12 months of follow-up

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,420 Previous Clinical Trials
6,747,330 Total Patients Enrolled
Duke UniversityOTHER
2,207 Previous Clinical Trials
3,219,098 Total Patients Enrolled
Brown UniversityOTHER
421 Previous Clinical Trials
520,758 Total Patients Enrolled
Olive View-UCLA Education & Research InstituteOTHER
31 Previous Clinical Trials
1,212,027 Total Patients Enrolled
RANDOTHER
126 Previous Clinical Trials
489,690 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
497 Previous Clinical Trials
29,837,630 Total Patients Enrolled
University of UtahOTHER
1,008 Previous Clinical Trials
1,785,866 Total Patients Enrolled
David Goldston, PhDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
220 Total Patients Enrolled
Joan R Asarnow, PhDPrincipal InvestigatorUniversity of California, Los Angeles
1 Previous Clinical Trials
418 Total Patients Enrolled

Eligibility Criteria

Age 15 - 24 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between the ages of 15 and 24.
You have had thoughts of harming yourself or made plans to do so within the past week.

Who else is applying?

What state do they live in?
Rhode Island100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Brown University100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "I actively meditate after years of struggling with depression and suicidal ideation. I am currently trying an antidepressant and seeking to further research in this area"
What questions have other patients asked about this trial?
  • "How long does screening visits take? When will i hear from you? What are the variables being tested?"
How many prior treatments have patients received?
2100.0%

How responsive is this trial?

Typically responds via
Email100.0%
Average response time
  • < 1 Day
Most responsive sites:
  1. Brown University: < 24 hours

Frequently Asked Questions

How many medical centers are administering this experiment?

"This clinical trial is available in 5 different venues, such as Duke University located in Durham, Olive View UCLA Education and Research Center situated in Sylmar, the University of Utah based out of Salt Lake City, plus two other locations." - Anonymous Online Contributor

Unverified Answer

Is the recruitment process for this experiment currently ongoing?

"As per the clinicaltrials.gov record, this medical trial is currently searching for participants. The initial post was published on October 17th 2022 and underwent an update on November 1st of that same year." - Anonymous Online Contributor

Unverified Answer

What is the total number of participants receiving treatment in this research?

"This clinical trial requires 1516 qualified participants to complete the study, with possible recruitment sites located at Duke University in Durham, North Carolina and Olive View UCLA Education and Research Center in Sylmar, Utah." - Anonymous Online Contributor

Unverified Answer

Am I eligible to join this experiment?

"To be eligible for the study, individuals must have attempted suicide and fall between the ages of 15 to 24. Approximately 1,516 participants are needed to complete this trial." - Anonymous Online Contributor

Unverified Answer

Are participants of advanced age eligible for this experimental procedure?

"The parameters of acceptance for this clinical trial dictate that participants must be between 15 and 24 years old." - Anonymous Online Contributor

Unverified Answer

Has the FDA granted authorization to Combined?

"We at Power have assigned Combined a safety rating of 2, as the data collected thus far indicates an acceptable level of security yet no proof of efficacy." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.