Clinical trial NCT03543865: Southwest Hub for American Indian Youth Suicide Prevention Research
Official title: Southwest Hub for American Indian Youth Suicide Prevention Research
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Suicide
Surveillance
Mental Health
Substance Use
Depressive Symptoms
Keywords: American Indian
Resilience
Native American
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-06-01
Enrollment: 304
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: The overall goal of the research component of the National Institute of Mental Health funded Southwest Hub for American Indian Youth Suicide Prevention Research is to identify effective, feasible and sustainable interventions to prevent suicide and promote resilience among American Indian (AI) youth. The proposed study will build on 20+ years of behavioral and mental health research and partnerships undertaken by the Center for American Indian Health (CAIH) at Johns Hopkins with the White Mountain Apache Tribe (WMAT).

The investigators primary research aim, to be undertaken with the White Mountain Apache, includes: 1) identification and voluntary enrollment of youth 10-24 years old using the WMAT established surveillance and case-management (CM) system who recently had a validated suicide attempt, ideation, or binge substance use episode with recent suicidal ideation; and 2) implementation of a Sequential Multiple Assignment Randomized Trial (SMART) to inform how to combine and tailor two brief interventions delivered by paraprofessional community mental health workers (CMHWs), with promising pilot data, to prevent further suicidal thoughts and behavior and promote resilience; and 3) evaluate what are the cost savings per study participant with the implementation of the Southwest Hub interventions: NH, ER, NH and ER. A secondary aim will be to evaluate the acceptability, feasibility and sustainability of the two brief interventions with other Southwest Hub partners, including the Navajo, San Carlos Apache, Hualapai, and Cherokee nations, who will have support from the Administrative Core of the Southwest Hub to implement their own local tribal suicide surveillance systems for community-based identification of at-risk youth.

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 (case management visit 1 and will be referred to mental health care-the standard protocol for the Apache system). 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. 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). This study will occur on the White Mountain Apache Tribe's Fort Apache reservation.

Eligibility criteria: Aim 1

Inclusion Criteria:

* 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.

Exclusion Criteria:

• 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

Inclusion Criteria:

* 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.

Exclusion Criteria:

• 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.

Primary outcomes:
measure: Suicide Ideation Questionnaire (SIQ/SIQ-JR)
timeFrame: Baseline - 6 months
measure: The Resiliency Scales
timeFrame: Baseline - 6 months
Secondary outcomes:
measure: Centers for Epidemiologic Studies of Depression (CESDR-10)
timeFrame: Baseline, 6 months
measure: The Children's Hope Scale (CHS)
timeFrame: Baseline, 6 months
measure: Multicultural Mastery Scale
timeFrame: Baseline, 6 months
measure: Rosenberg Self Esteem Scale
timeFrame: Baseline, 6 months
measure: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Risk Score
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Whiteriver
country: United States
facility: Johns Hopkins Center for American Indian Health
state: Arizona
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Mary Cwik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.