Depressive Symptoms Clinical Trial
Official title:
Southwest Hub for American Indian Youth Suicide Prevention Research
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.
Status | Recruiting |
Enrollment | 304 |
Est. completion date | November 30, 2024 |
Est. primary completion date | November 30, 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. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Center for American Indian Health | Whiteriver | Arizona |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins Bloomberg School of Public Health | National Institute of Mental Health (NIMH) |
United States,
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 |
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