Southwest Hub for American Indian Youth Suicide Prevention Research

Depressive Symptoms Clinical Trial

Official title:

Southwest Hub for American Indian Youth Suicide Prevention Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03543865
• Other study ID #: 8138
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2023
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: Mary Cwik, PhD
• Phone: 443-287-5172
• Email: mcwik1[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT03132766

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

AIM 1

Inclusion Criteria:

• Native American youth ages 10 to 24 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.

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Mental Health
• Substance Use
• Substance-Related Disorders
• Suicide
• Surveillance

Intervention

Behavioral:
• New Hope (NH)
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.
• Elders Resilience (ER)
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.

Other:
• Case Management (CM)
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.

Locations

Country	Name	City	State
United States	Johns Hopkins Center for American Indian Health	Whiteriver	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suicide Ideation Questionnaire (SIQ/SIQ-JR)	The SIQ is a 15-item scale that analyzes frequency and severity of suicidal ideation over the past 6 months. Items are scored on a 7-point scale ranging from 0 "I never had this thought" to 6 "Almost every day." Scores of 30 for the SIQ and 23 for the SIQ-JR indicate severe suicidal ideation and need for clinical intervention. The scale has been used among AI adolescents with sound psychometric properties (Cronbach's alpha=0.97).	Baseline - 6 months
Primary	The Resiliency Scales	Measured by The Resiliency Scales, these are self-report scales measuring the individual's Sense of Mastery (MAS; composed of 20 items), the Sense of Relatedness (REL; 24 items), and the Emotional Reactivity (REA; 20 items). Each item has five response choices ranging from 0 (Never) to 4 (Almost Always).	Baseline - 6 months
Secondary	Centers for Epidemiologic Studies of Depression (CESDR-10)	The Centers for Epidemiologic Studies of Depression (CESDR-10) is a self-report scale used to measure depressive symptoms (Cronbach's alpha ranged from 0.90 to 0.91 in a validation study). Scores on the CESDR-10 range from 0 (minimum) to 40 (maximum) with higher scores representing higher frequency of experiencing depression symptoms. CESDR-10 score is summed to provide an overall total for each participant. The full version has been widely used among adolescent and AI populations, including Apache youth.	Baseline - 6 months
Secondary	Children's Negative Cognitive Errors Scale	The Children's Negative Cognitive Errors Scale is a 17-item self-report scale that has 5 subscales (underestimation of the ability to cope; personalizing without mind reading; mind reading; selective abstraction; overgeneralizing) assessing cognitions about social/peer rejection, group activity competence and academic competence, and demonstrated excellent internal consistency reliability (Cronbach's alpha=0.89). The participant indicates on a 5-point scale how similarly he/she would think in this situation ranging from "almost exactly like I would think" (5 points) to "not at all like I would think (1 point). Item scores are summed to produce a total score ranging from 16 to 80; higher scores indicate higher levels of negative cognitive errors. It has been previously used in a sample of Apache youth.	Baseline - 6 months
Secondary	Problem-oriented screening instrument (POSIT)	The Problem-oriented screening instrument (POSIT) is a 139-item scale assessing 10 potential problem areas (with associated subscales) including substance use and abuse, physical health, mental health, family relations, peer relations, educational status, vocational status, social skills, leisure/recreation, aggressive behavior/delinquency. For the current study, the team will only administer the Family Relations subscale, which includes 11 items measuring poor family functioning around parenting, communication and monitoring. Each item has a "yes" or "no" response and each "yes" item contributes to a total risk score for this functional area; the cut-off risk score for Family Relations is 4. It has been used with Apache adolescents and demonstrated adequate internal consistency reliability (alpha=0.73).	Baseline - 6 months
Secondary	Urgency to Act, Lack of Perseverance, Lack of Premeditation, and Sensation Seeking (UPPS) Impulsive Behavior Scale	UPPS is a 45-item inventory designed to measure four personality pathways to impulsive behavior: Urgency to Act, Lack of Perseverance, Lack of Premeditation, and Sensation Seeking. Each item is rated on a 4-point scale from 1= strongly disagree to 4 = strongly agree. Internal consistency has been established for each of the four pathways, with have high internal consistency reliability among Apache youth (Cronbach's alpha=0.92).	Baseline - 6 months
Secondary	Multicultural Mastery Scale	This scale is an adapted version of the self- and communal mastery scales for adolescents. This measure explores a wide parameter of topics, including youth resilience, stress and coping, and protection from substance abuse and psychopathology. Each item is rated on a 3-point scale from 0 = not at all, 1 = somewhat, and 2 = a lot.	Baseline - 6 months
Secondary	Voices of Indian Teens Cultural Issues and Interest	This is a sub-set of 5 items that assesses the importance following traditional AI practices and values. Questions are drawn from the Voices of Indian Teens Survey (NIAAA grant R01 AA 08474) and have been used widely with AI teens including the Apache.	Baseline - 6 months
Secondary	Rosenberg Self Esteem Scale	This scale is a widely used 10-item self-report scale measuring feelings of self-worth, acceptance and self-esteem. Respondents rate how much they agree/disagree on a 5-point scale ranging from 1= strongly disagree to 5 = strongly agree. The scale has been used with adolescent AIs with good reliability (alpha=0.84)	Baseline - 6 months
Secondary	The Children's Hope Scale (CHS)	The Children's Hope Scale (CHS) consists of 6 items and is based on a conceptualization of hope as consisting of two factors: agency and pathways. Agency is defined as the perception by the child that he or she is able to initiate and sustain action toward a goal. The pathways factor involves the child's capability of producing the means to achieve these goals. The CHS includes two subscales measuring agency (3 items) and pathways (3 items). Each item asks the respondent to choose how he/she thinks about himself/herself and how they do things in general on a 6-point scale ranging from "none of the time" to "all of the time". Scores range from 0 to 18 on each of the two subscales, higher level scores indicate higher levels of agency or pathways respectively. The two subscales are scored to produce an overall hope score for each participant, with higher scores indicating higher levels of overall hope as conceptualized by the CHS.	Baseline - 6 months
Secondary	The ASSIST	The World Health Organization (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) is a questionnaire that screens for all levels of problem or risky substance use in adults. A risk score can be provided for each substance, and scores are grouped into 'low risk', 'moderate risk' or 'high risk'. It has been validated in youth and adolescents, as well as adults.	Baseline - 6 months
Secondary	Locally created items	During initial research meetings, the investigators asked the team about changes the study team had observed in children as a result of the New Hope and Elders curriculum. The investigators then generated a list of items to include on the research study to help in capturing locally relevant changes in youth's thoughts, feelings and behaviors that could occur as a result of the interventions under study.	Baseline - 6 months
Secondary	Applied Mental Health Research Group's Measures of Acceptability and Feasibility	Acceptability and feasibility will be measured using 2 subscales from the Applied Mental Health Research Group's Implementation Science Research Measures. The acceptability scale has 13-items and the Feasibility scale has 20-item scales. Both scales were developed by researchers at Johns Hopkins to measure implementation of mental health programs in low resource settings. Items included in these scales are based on leading implementation science frameworks (Consolidated Framework for Implementation; Reach, Effectiveness, Adoption, Implementation, and Maintenance; and a conceptual model of evidence based implementation in public services sectors), and knowledge gathered from health systems, dissemination and implementation science experts. The scales have demonstrated good psychometric properties across a range of stakeholder groups in low income settings internationally (alpha=0.79, alpha=0.77). Each scale is scored on a 4-point ordinal scale ranging from 0 "not at all" to 3 "a lot."	12 months - 24 months
Secondary	Program Sustainability Assessment Tool (PSAT)	The PSAT was developed based on the Public Health Program Capacity for Sustainability framework. Researchers at Johns Hopkins have adapted this for use in low resource settings related to mental health programming. Adaptations included simplification of language, additions of items, inclusion of a leadership domain, and reductions in number of response categories. The adapted version of the PSAT has been validated in a sample of community-based mental health providers, using a novel vignette based testing approach. Results from the validation study indicated high internal consistency reliability across all subscales (0.93-0.97) and strong correlations of each subscale to overall ratings of program sustainability.	12 months - 24 months
Secondary	Opioid Risk Tool (ORT)	The Opioid Risk Tool (ORT) is a brief, self-report screening tool designed for use with adult patients in primary care settings to assess risk for opioid abuse among individuals prescribed opioids for treatment of chronic pain. Patients categorized as high-risk are at increased likelihood of future abusive drug-related behavior. The ORT can be administered and scored in less than 1 minute and has been validated in both male and female patients, but not in non-pain populations.	Baseline - 6 months
Secondary	Opioid Questions	The Opioid questions ask about lifetime and past year use of opioids, history of overdose, knowledge about others' drug overdoses, medical assisted treatment, and Southwest Native American adapted questions related to treatment history and effectiveness.	Baseline - 6 months