ER + NH + CM Interventions for Suicide Prevention

Overseen By Victoria O'Keefe, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Severe medical, psychiatric, drug problems, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

304 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

1. To use a SMART design to evaluate which of four sequences of New Hope (NH), Elders Resilience (ER) and Case Management (CM) have the greater effects on immediate and longer-term suicidal ideation (primary outcome) and resilience (secondary outcome) among American Indian (AI) adolescents ages 10-24 identified at risk for suicide. Hypotheses: i. New Hope vs. CM alone will significantly reduce participant suicidal ideation. ii. Elders Resilience vs. CM alone will significantly improve participant resilience. iii. New Hope followed by Elders Resilience will have the strongest effects on suicidal ideation and resilience. iv. CM alone will have the weakest effects of all combinations. Secondary Aims: 2. To examine mediators and moderators of treatment effectiveness and sequencing in order to determine which types and sequence of interventions is best suited for which youth. 3. To assess the acceptability, feasibility and capacity for sustainability of the Hub's key intervention components (Surveillance/Case Management, New Hope and Elders' Resilience) from the perspective of multiple stakeholders as they are implemented across different tribes.

Who Is on the Research Team?

Mary Cwik, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline and Initial Randomization

Youth complete baseline assessment and are randomized to New Hope plus Case Management or Case Management alone

1 day

1 visit (in-person)

First Treatment Phase

Participants receive New Hope intervention plus Case Management or Case Management alone, followed by assessment after 30 days

4 weeks

1 visit (in-person) for assessment

Second Treatment Phase

Participants are re-randomized to Elders' Resilience intervention plus Case Management or Case Management alone, followed by assessment after another 30 days

4 weeks

1 visit (in-person) for assessment

Follow-up

Participants are monitored for long-term outcomes, including suicidal ideation and resilience, with a final assessment 6 months post-enrollment

3 months

1 visit (in-person) for final assessment

What Are the Treatments Tested in This Trial?

Interventions

• Case Management
• Elders Resilience
• New Hope

Trial Overview 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.

How Is the Trial Designed?

Group I: New Hope (NH), Elders' Resiliency (ER), Case Management (CM) Experimental Treatment 3 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 Treatment 2 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 Treatment 2 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 Condition Experimental Treatment 1 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.

Case Management is already approved in United States for the following indications:

Approved in United States as Case Management for:

• Hoarding Disorder

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+