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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 baseline - 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

Select...

I am a Native American between 10 and 24 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline - 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline - 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline - 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Suicide Ideation Questionnaire (SIQ/SIQ-JR)

The Resiliency Scales

Secondary study objectives

Centers for Epidemiologic Studies of Depression (CESDR-10)

Nootropic Agents

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

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.

0 / 1Eligibility criteria met