Southwest Hub for American Indian Youth Suicide Prevention Research

NCT03543865 | Completed Results DMC

• 2 other identifiers: IRB00008138-25U19MH113136-02
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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 10-29 identified at risk for suicide.
2. 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. 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.

Conditions

Suicide; Surveillance; Mental Health; Substance Use; Depressive Symptoms

Keywords

American Indian; Resilience; Native American

Outcome Measures

Primary Outcomes (2)

• Suicide Ideation Questionnaire (SIQ)

  The SIQ for adults (ages \>14; 27 items) and SIQ-Junior for youth (ages ≤14; 13 items). Both measure frequency of suicidal thoughts on a 7-point Likert scale (0=Never to 6=Almost Every Day). Raw scores range from 0-162 (SIQ) and 0-78 (SIQ-JR); higher raw scores indicate greater suicidal ideation. Raw scores of ≥30 on the SIQ and ≥23 on the SIQ-JR indicate clinically severe suicidal ideation. To create comparable scores across age groups, raw scores were converted to z-scores based on the study sample's baseline distribution, calculated separately for adults and youth using their respective scale versions. A constant of 10 was added to all z-scores to facilitate interpretation. Interpretation of Z-scores: * Each unit change represents one standard deviation from the sample * Z-scores \>10 indicate above-average suicidal ideation (worse outcome) * Z-scores \<10 indicate below-average suicidal ideation (better outcome) A Z-score of 0 represents the population mean

  Baseline, 30 days, 60 days, 90 days, 180 days

• The Resiliency Scales

  Resilience Scales for Children and Adolescents (RSCA), adapted and validated with community input. The RSCA measures 3 domains of resilience using a 4-point Likert scale (0=Not at All, 1=A little bit, 2=A medium amount, 3=A lot): * Sense of Mastery: 20 items assessing self-efficacy and control (range: 0-60; higher better) * Sense of Relatedness: 18 items assessing trust and support from relationships (range: 0-54; higher better) * Emotional Reactivity: 24 items assessing vulnerability to stress and negative emotions (range: 0-72; lower better) 1. Items are summed within each subscale 2. Mastery and Relatedness subscales are summed to create a Resource Index (range: 0-114) 3. The Total Resilience Score is calculated as: Resource Index minus Emotional Reactivity Total Resilience Score Range: -72 to 114 Interpretation: * Higher scores indicate greater resilience (better outcome) * Better scores reflect more personal and relational resources combined with lower emotional vulnerab

  Baseline, 30 days, 60 days, 90 days, 180 days

Secondary Outcomes (5)

• Centers for Epidemiologic Studies of Depression (CESDR-10)

  Baseline, 30 days, 60 days, 90 days, 180 days

• The Children's Hope Scale (CHS)

  Baseline, 30 days, 60 days, 90 days, 180 days

• Multicultural Mastery Scale

  Baseline, 30 days, 60 days, 90 days, 180 days

• Rosenberg Self Esteem Scale

  Baseline, 30 days, 60 days, 90 days, 180 days

• Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Risk Score

  Baseline, 30 days, 60 days, 90 days, 180 days

Study Arms (4)

New Hope (NH)

EXPERIMENTAL

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 10-29 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.

Behavioral: New Hope (NH); Other: Case Management (CM)

Elders' Resiliency (ER)

EXPERIMENTAL

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 10-29 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).

Behavioral: Elders Resilience (ER); Other: Case Management (CM)

Control Condition

OTHER

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 10-29 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.

Other: Case Management (CM)

New Hope (NH), Elders' Resiliency (ER), Case Management (CM)

EXPERIMENTAL

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 10-29 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.

Behavioral: New Hope (NH); Behavioral: Elders Resilience (ER); Other: Case Management (CM)

Interventions

New Hope (NH) BEHAVIORAL

New Hope will be implemented over 1 visit (2-4 hours) in a youth-preferred setting after Emergency Department (ED) discharge for a suicide attempt, and in the past few years has been updated to also target suicide ideation and binge behavior. NH emphasizes the seriousness of a suicide attempt; teaches coping skills to reduce risk, including emotion regulation, cognitive restructuring, social support, and safety planning; and helps participants overcome barriers to treatment motivation, initiation, and adherence. A center-piece of the intervention is a 20-minute video produced by with Native actors, vignettes specific to this community, and Elders speaking in Apache (with sub-titles) about the seriousness of suicide, its impact on the community, their concern for the adolescent, and beliefs about the communal importance of each individual's life.Youth will be encouraged to choose a support person from his/her family to take part in the intervention.

New Hope (NH); New Hope (NH), Elders' Resiliency (ER), Case Management (CM)

Elders Resilience (ER) BEHAVIORAL

Elders' Resiliency is a monthly manualized curriculum taught by Elders in the community intended to bolster Apache youths' resilience to suicide ideation, attempts and substance abuse by promoting Apache cultural identity and values, youth's self-worth and role in the community, and fostering connectedness to society and community, with an emphasis on extended family as a nexus of strength. Each lesson introduces youth to cultural knowledge, stories, and songs with an emphasis on respect and the sacredness of each life. Our community-based Apache staff will select Elders who both express an interest in the current project and have demonstrated affinity and skill for teaching the current curriculum in the schools. After this group of Elders is recruited and agree to participate, they will be paired with our paraprofessional Apache study staff.

Elders' Resiliency (ER); New Hope (NH), Elders' Resiliency (ER), Case Management (CM)

Case Management (CM) OTHER

Research Program Assistants, who are trained Surveillance System Staff, will conduct the monitoring and case management visits in participants' homes or other private settings at baseline, 1, 2, 3 and 6 months post-enrollment. The CM visit includes rapport-building, use of the Suicide Ideation Questionnaire (SIQ) to assess imminent risk, and if youth report not yet having connected to services, referral to Apache Behavioral Health Services (ABHS), the local community mental health center. At CM visits, the Research Program Assistants will also monitor participants' completion of the study battery, which will be self-administered using tablets. In addition, Research Program Assistants will score the SIQ before leaving the youth. If the SIQ reveals the participant is at imminent risk, Research Program Assistants will employ a protocol for rescue services, which involves triaging youth immediately to the ED for further assessment and care.

Control Condition; Elders' Resiliency (ER); New Hope (NH); New Hope (NH), Elders' Resiliency (ER), Case Management (CM)

Eligibility Criteria

• Age: 16 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Native American youth ages 10 to 29 years old.
• Reside on or near the Fort Apache Indian Reservation.
• Parent/guardian consent for youth under 18 years old.
• Suicide ideation, binge substance use with recent (i.e. within the last 3 months) suicide ideation, or suicide attempt in the past 30 days as identified and verified by the surveillance system or release from inpatient care related to suicide ideation or attempt within past 30 days.
• Terms and Definitions: Definitions for reportable behaviors are modeled on the Columbia Classification Algorithm for Suicide Assessment (C- CASA).\[11\] Suicide attempt: intentional self-injury with intent to die. (Aborted and interrupted suicide attempts are included as part of this category). Suicidal ideation: thoughts to take one's own life with or without preparatory action. Binge substance use with recent ideation, defined by Apache stakeholders, as consuming substances with the intention of modifying consciousness and resulting in being found unresponsive or requiring ED treatment and answering positively to a 1-item screening question on the assessment indicating suicide ideation within the past three months.

You may not qualify if:

• Factors identified at baseline that preclude full participation, including: unstable and severe medical, psychiatric or drug use problem that necessitates inpatient treatment; acute suicidal or homicidal ideation requiring immediate intervention; recent, severe stressful life events such as physical or sexual abuse, or violent crime victimization that requires specific and high intensity interventions or out of home placement. Participants must speak English and not be severely visually impaired. Foster children will not be included. Ambiguous cases will be reviewed by one of the co-PIs before being deemed eligible for recruitment.
• Aim 3
• Youth over the age of 16 or adults over the age of 18.
• A person with an interest or concern related to youth suicide among AI populations.
• Factors identified at baseline that preclude full participation including: being under the influence of a substance; active psychosis or mania; any other condition that makes an individual lack capacity to give consent. Foster children will not be included. Participants must speak English and not be severely visually impaired. Ambiguous cases will be reviewed by one of the co-PIs before being deemed eligible for recruitment.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Johns Hopkins Center for American Indian Health

Whiteriver, Arizona, 85941, United States

Location

Related Publications (1)

• O'Keefe VM, Haroz EE, Goklish N, Ivanich J; Celebrating Life Team; Cwik MF, Barlow A. Employing a sequential multiple assignment randomized trial (SMART) to evaluate the impact of brief risk and protective factor prevention interventions for American Indian Youth Suicide. BMC Public Health. 2019 Dec 12;19(1):1675. doi: 10.1186/s12889-019-7996-2.

  PMID: 31830933 DERIVED

MeSH Terms

Conditions

Suicide; Psychological Well-Being; Substance-Related Disorders; Depression

Interventions

Case Management

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Personal Satisfaction; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Limitations and Caveats

Study limitations include constraints on generalizability, as our sample was predominantly female (73%) and conducted within a single Tribal Nation, limiting the generalizability of our findings. The study design did not permit isolation of the specific effects of case management alone; this was intentional and ethically necessary. The pandemic fundamentally compromised ERC implementation, and the intervention's full potential should be evaluated in a future study.

Results Point of Contact

• Title: Mary Cwik
• Organization: Johns Hopkins University

mcwik1@jhu.edu

(410) 960-9503

Study Officials

• Mary Cwik, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: June 1, 2018
• Study Start: March 25, 2019
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: January 23, 2026
• Results First Posted: January 23, 2026

Record last verified: 2026-01

Locations

US (1)