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ER + NH + CM Interventions for Suicide Prevention
N/A
Recruiting
Led By Mary Cwik, PhD
Research Sponsored by Johns Hopkins Bloomberg School of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Native American youth ages 10 to 24 years old.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months - 24 months
Awards & highlights
Study Summary
This trial will test which combination of three interventions (New Hope, Elders Resilience, and Case Management) is most effective at reducing suicidal ideation and increasing resilience in American Indian adolescents.
Who is the study for?
This trial is for Native American youth aged 10-24 living near the Fort Apache Indian Reservation, who have had suicidal thoughts or behaviors, or substance use issues in the last 3 months. Participants under 18 need parental consent. Those with recent suicide attempts are also eligible.Check my eligibility
What is being tested?
The study tests sequences of three interventions: New Hope (NH), Elders Resilience (ER), and Case Management (CM) to see which combination best reduces suicidal thoughts and increases resilience in at-risk American Indian adolescents.See study design
What are the potential side effects?
Since this trial involves psychological support programs rather than medications, traditional side effects are not expected. However, participants may experience emotional discomfort when discussing sensitive topics like suicide and substance abuse.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a Native American between 10 and 24 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months - 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months - 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Suicide Ideation Questionnaire (SIQ/SIQ-JR)
The Resiliency Scales
Secondary outcome measures
Applied Mental Health Research Group's Measures of Acceptability and Feasibility
Centers for Epidemiologic Studies of Depression (CESDR-10)
Nootropic Agents
+11 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: New Hope (NH), Elders' Resiliency (ER), Case Management (CM)Experimental Treatment3 Interventions
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type. All youth will complete another study assessment after 30 days.After another 30-days, all participants will be re-assessed/re-randomized, using the same blocking and 1:1 ratio to either the ER intervention plus CM, or CM alone.
Group II: New Hope (NH)Experimental Treatment2 Interventions
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
Group III: Elders' Resiliency (ER)Experimental Treatment2 Interventions
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation.
All youth will complete another study assessment after 30 days. The 30-day time frame will allow ample time to complete the NH intervention with participants and assess any changes in youth's mental health status for all study arms. Following another 30-day period, all participants will be re-assessed and re-randomized, using the same blocking and 1:1 ratio to either the Elders' Resilience (ER) intervention plus CM, or CM alone. To track long term outcomes, all youth will complete a final assessment 3 month later (6 months post-enrollment).
Group IV: Control ConditionExperimental Treatment1 Intervention
The control condition will only receive Case Management (CM) (n=76).
The investigators will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders' Resilience intervention (ER), Case Management (CM) and the combination of these approaches on reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are confirmed by surveillance case managers to have recently experienced suicide ideation, attempt or a binge substance use and ideation. Youth who assent will complete the baseline (CM visit 1 and will be referred to mental health care). During the same visit, youth will be randomized 1:1 to either New Hope (NH) plus Case Management (CM), or CM alone, using a blocked randomized design, stratifying participants by age and event type.
Find a Location
Who is running the clinical trial?
Johns Hopkins Bloomberg School of Public HealthLead Sponsor
410 Previous Clinical Trials
2,116,626 Total Patients Enrolled
Mary Cwik, PhDPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health
4 Previous Clinical Trials
479 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The study uses specific definitions to classify certain behaviors related to suicide. If you have intentionally hurt yourself with the intention of ending your life, have had thoughts of taking your own life, or have recently used drugs or alcohol in a harmful way while experiencing suicidal thoughts, you may not be eligible for the study.You have had thoughts of suicide, have recently engaged in heavy drug or alcohol use along with thoughts of suicide within the last 3 months, or have attempted suicide in the past 30 days.I am a Native American between 10 and 24 years old.You live in or close to the Fort Apache Indian Reservation.My parent or guardian agrees to my participation if I'm under 18.This is not a criterion. It appears to be a label or reference to a specific section or goal of the clinical trial.
Research Study Groups:
This trial has the following groups:- Group 1: Control Condition
- Group 2: Elders' Resiliency (ER)
- Group 3: New Hope (NH), Elders' Resiliency (ER), Case Management (CM)
- Group 4: New Hope (NH)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the ultimate aim of this clinical investigation?
"The primary outcome being monitored over the 6-month period is The Resiliency Scales. Secondary objectives are measured via the Opioid Risk Tool (ORT), World Health Organization's Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) and a selection of locally derived items chosen by the research team to capture changes in youth behaviour as result of interventions under study."
Answered by AI
Are there any opportunities for people to enroll in this experiment presently?
"Affirmative. Clinicaltrials.gov reports that the clinical study in question, which was initially posted on March 25th 2019, is still actively recruiting participants. A total of 304 individuals are sought to participate at 1 site."
Answered by AI
How many individuals are engaged in this research effort?
"That is correct. According to clinicaltrials.gov, this medical trial was initially posted on March 25th 2019 and has been actively searching for participants ever since its last update in July 15th 2022. A total of 304 patients are required at a single location."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
What portion of applicants met pre-screening criteria?
Did not meet criteria
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