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supportED group for Substance Abuse

N/A

Waitlist Available

Led By Claudia-Santi F Fernandes, Ed.D., LPC

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, immediately after gameplay (up to 30 minutes), and at 3-months.

Awards & highlights

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, immediately after gameplay (up to 30 minutes), and at 3-months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, immediately after gameplay (up to 30 minutes), and at 3-months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately after gameplay (up to 30 minutes), and at 3-months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessing the Digital Experience at Post-Gameplay

Measuring Acceptability at Post-Gameplay

Measuring Feasibility at Post-Gameplay

+2 more

Secondary outcome measures

Change From Baseline in Anxiety at 3-months.

Change From Baseline in Coping Strategies on Brief COPE Scale at Post-gameplay and 3-months

Change From Baseline in Depression at 3-months.

+8 more

Other outcome measures

Change From Baseline in Suicide Risk at 3-months

Trial Design

2Treatment groups

Experimental Treatment

Group I: supportED groupExperimental Treatment1 Intervention

Participants in this group will engage with the digital game for one session (~45min) and will receive NIDA and NIMH pamphlets on substance misuse and mental health for youth at the end of the session. Participants will use a dedicated device (e.g., tablet, laptop, or desktop) to access their digital experience on the web. The research staff and a school-based provider will be present to monitor gameplay, to provide support, if needed, and to field questions in person.

Group II: Control groupExperimental Treatment1 Intervention

Participants in this group will engage with a non-health-related game for one session (~45min) and will receive NIDA and NIMH pamphlets on substance misuse and mental health for youth at the end of the session. Participants will use a dedicated device (e.g., tablet, laptop, or desktop) to access their digital experience on the web. The research staff and a school-based provider will be present to monitor gameplay, to provide support, if needed, and to field questions in person.

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Who is running the clinical trial?

National Center for Advancing Translational Science (NCATS)NIH

99 Previous Clinical Trials

36,248 Total Patients Enrolled

Yale UniversityLead Sponsor

1,847 Previous Clinical Trials

2,736,467 Total Patients Enrolled

17 Trials studying Substance Abuse

3,402 Patients Enrolled for Substance Abuse

National Center for Advancing Translational Sciences (NCATS)NIH

320 Previous Clinical Trials

401,669 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Digital Game Targeting Suicide Prevention in Adolescents Who Report Substance Misuse

2022. "A Digital Game Targeting Suicide Prevention in Adolescents Who Report Substance Misuse". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05517382.