supportED group for Suicide

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
High School, Meriden, CTSuicide+2 MoresupportED - Other
Eligibility
13 - 19
All Sexes
What conditions do you have?
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Study Summary

This trial aims to design and create a digital game to reduce suicide risk among adolescents misusing opioids. Focus groups and interviews will inform the game development and a pilot study will assess user experience.

Eligible Conditions
  • Substance Abuse
  • Suicide
  • Opioid Abuse

Treatment Effectiveness

Study Objectives

4 Primary · 16 Secondary · Reporting Duration: Baseline, Immediately after Gameplay, up to 30 minutes, and at 3-months

Baseline, Immediately after Gameplay, up to 30 minutes, and at 3-Months
Change from Baseline in Knowledge about the Safety Planning Approach at post-gameplay and 3-months.
Baseline, Immediately after Gameplay, up to 30 minutes, and at 3-Months.
Change from Baseline in Adolescent Well-Being at post-gameplay and 3-months.
Anxiety
Change from Baseline in Coping Strategies on brief COPE Scale at post-gameplay and 3-months
Mental Depression
Change from Baseline in Help-Seeking Behavior at post-gameplay and 3-months.
Change from Baseline in Intentions to Use a Safety Approach at post-gameplay and 3-months.
Change from Baseline in Severity of Suicidal Thoughts and Associative Behaviors on Concise Health Risk Tracking Self-Report (CHRT-SR) at post-gameplay and 3-months.
Change from Baseline in Substance Misuse in the Past 30-Days at post-gameplay, and 3-months
Baseline, Immediately after Gameplay, up to 30 minutes, and at 3-months
Change from Baseline in Emotion Regulation at post-gameplay and 3-months
Change from Baseline in Mindfulness at post gameplay and 3-months
Baseline, and at 3-Months.
Change from Baseline in Anxiety at 3-months.
Change from Baseline in Depression at 3-months.
Change from Baseline in Severity of Suicidal Thoughts and Associative Behaviors on Concise Health Risk Tracking Self-Report (CHRT-SR) at 3-months.
Change from Baseline in Substance Misuse in the Past 30-Days at 3-months
Change from Baseline in Suicide Risk at 3-months
Immediately after Gameplay, up to 30 minutes
Measuring Acceptability at Post-Gameplay
Measuring Feasibility at Post-Gameplay
Measuring Usability at Post-Gameplay
Measuring User Experience at Post-Gameplay

Trial Safety

Trial Design

1 Treatment Group

supportED group
1 of 1

Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: supportED group · No Placebo Group · N/A

supportED group
Other
Experimental Group · 1 Intervention: supportED · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, immediately after gameplay, up to 30 minutes, and at 3-months

Who is running the clinical trial?

National Center for Advancing Translational Science (NCATS)NIH
99 Previous Clinical Trials
39,835 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
199 Previous Clinical Trials
355,894 Total Patients Enrolled
1 Trials studying Suicide
24 Patients Enrolled for Suicide
Yale UniversityLead Sponsor
1,711 Previous Clinical Trials
20,477,967 Total Patients Enrolled
4 Trials studying Suicide
308 Patients Enrolled for Suicide
Claudia-Santi F Fernandes, Ed.D., LPCPrincipal InvestigatorYale School of Medicine

Eligibility Criteria

Age 13 - 19 · All Participants · 4 Total Inclusion Criteria

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Frequently Asked Questions

Is participation available to individuals over the age of 30 in this trial?

"The investigation requires volunteers who are between the ages of 13 and 19." - Anonymous Online Contributor

Unverified Answer

Have any fresh participants been enrolled for this research endeavor?

"Per the clinicaltrials.gov website, this research is currently accepting participants. The study was initially posted on December 21st 2022 and updated most recently on January 11th 2023." - Anonymous Online Contributor

Unverified Answer

What is the scope of participant recruitment for this trial?

"Indeed, clinicaltrials.gov confirms that recruitment for this medical study is underway. This trial was initially posted on December 21st 2022 and last updated on January 11th 2023; 60 patients are needed from one site to complete the experiment." - Anonymous Online Contributor

Unverified Answer

Is my profile compatible with the requirements of this medical experiment?

"This medical study seeks 60 adolescents aged 13-19 who have struggled with suicidal thoughts or behaviors. To qualify, they must attend a school that has a provider for behavioral health, possess prior experience of substance misuse in their lifetime, be willing to complete pre and post assessments during one session (~45 minutes), engage with the game provided as part of the trial (if assigned to experimental group) and take part in a focus group following gameplay (60 mins). Additionally, minors require both parental/guardian consent and assent." - Anonymous Online Contributor

Unverified Answer

What are the primary goals of this healthcare study?

"The primary result of this investigation, measured over an immediate-to-30 minute timeframe post gameplay and is assessing User Experience. Secondary outcomes are Change from Baseline in Depression (as evaluated through the Patient Health Questionnaire-9 scale), Knowledge about Safety Planning Approach (based on 6 custom items) and Severity of Suicidal Thoughts/Behaviors as assessed by Concise Health Risk Tracking Self Report with data collected via a secured RedCap system." - 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.