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The Elders' Resilience Curriculum

Primary Purpose

Suicidal Ideation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Elders' Resilience Curriculum
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicidal Ideation focused on measuring American Indian, Alaska Native, Suicide prevention

Eligibility Criteria

9 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ages 9-14 years Enrolled in a school where the Elders' Resilience Curriculum is delivered Participating in the Elders' Resilience Curriculum Program Exclusion Criteria: Parent/Guardian objection to youth participation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Elders' Resilience Curriculum Recipients

    Arm Description

    Youth aged 9-14 who receive the Elders' Resilience Curriculum

    Outcomes

    Primary Outcome Measures

    Change in reasons for life as assessed by the Reasons for Life Scale
    11 self-report items from the Reasons for Life scale, measures beliefs and experiences that make youth feel like life is enjoyable, worthwhile, and meaningful. Responses range from 0 (not at all) to 2 (a lot) with higher scores indicating more reasons for life.
    Change in cultural connectedness as assessed by the Cultural Connectedness Scale - Short Form
    The Cultural Connectedness Scale-short version is a 9-item self-report measure that assesses connection to cultural identity, traditions, and spirituality among First Nations youth. Responses vary - five questions are yes/no, three questions range from 0 (disagree) to 2 (agree) and the last question ask about frequency, ranging from 0 (never) to 4 (every day). Higher agreement (i.e., "yes" or "agree" responses) indicate greater levels of cultural connectedness.

    Secondary Outcome Measures

    Change in awareness of connectedness as assessed by the Awareness of Connectedness Scale
    The Awareness of Connectedness Scale is a 12-item self-report measure that evaluates awareness of connection with self, family, community, and the natural environment. Responses range from 0 (not at all) to 2 (a lot) with higher scores representing greater levels of awareness of connectedness.

    Full Information

    First Posted
    September 13, 2023
    Last Updated
    October 10, 2023
    Sponsor
    Johns Hopkins Bloomberg School of Public Health
    Collaborators
    National Institute of Mental Health (NIMH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06045273
    Brief Title
    The Elders' Resilience Curriculum
    Official Title
    The Elders' Resilience Curriculum: Toward Building Empirical Evidence Around a Culturally-Grounded, Strengths-Based Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 15, 2023 (Anticipated)
    Primary Completion Date
    May 31, 2024 (Anticipated)
    Study Completion Date
    May 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins Bloomberg School of Public Health
    Collaborators
    National Institute of Mental Health (NIMH)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The overall goal of this research is to better understand if and how the Elders' Resilience Curriculum (ERC), a culturally grounded, school-based upstream suicide prevention program taught by White Mountain Apache Tribe (WMAT) Elders to youth, promotes connectedness, cultural strengths, and reasons for living among American Indian youth.
    Detailed Description
    The overall goal of this research is to better understand if and how the Elders' Resilience Curriculum (ERC), a culturally grounded, school-based upstream suicide prevention program taught by White Mountain Apache Tribe (WMAT) Elders to youth, promotes connectedness, cultural strengths, and reasons for living among American Indian youth. Prior to this trial, the investigators collaborated with WMAT research partners to gather qualitative data to identify key protective factors and core components of the ERC. After identifying key protective factors and core components of the ERC, the investigators developed a culturally adapted assessment battery and theoretical model to assess the ERC. This study works with White Mountain Apache tribal community partners to collaboratively pilot test a rigorous evaluation of the ERC.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicidal Ideation
    Keywords
    American Indian, Alaska Native, Suicide prevention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Elders' Resilience Curriculum Recipients
    Arm Type
    Experimental
    Arm Description
    Youth aged 9-14 who receive the Elders' Resilience Curriculum
    Intervention Type
    Behavioral
    Intervention Name(s)
    Elders' Resilience Curriculum
    Other Intervention Name(s)
    ERC
    Intervention Description
    The Elders' Resilience Curriculum (ERC) is a culturally grounded, school-based program taught by White Mountain Apache Tribe (WMAT) Elders to youth. It is designed to prevent suicide ideation and behaviors for American Indian youth
    Primary Outcome Measure Information:
    Title
    Change in reasons for life as assessed by the Reasons for Life Scale
    Description
    11 self-report items from the Reasons for Life scale, measures beliefs and experiences that make youth feel like life is enjoyable, worthwhile, and meaningful. Responses range from 0 (not at all) to 2 (a lot) with higher scores indicating more reasons for life.
    Time Frame
    Baseline, 12 weeks, 34 weeks
    Title
    Change in cultural connectedness as assessed by the Cultural Connectedness Scale - Short Form
    Description
    The Cultural Connectedness Scale-short version is a 9-item self-report measure that assesses connection to cultural identity, traditions, and spirituality among First Nations youth. Responses vary - five questions are yes/no, three questions range from 0 (disagree) to 2 (agree) and the last question ask about frequency, ranging from 0 (never) to 4 (every day). Higher agreement (i.e., "yes" or "agree" responses) indicate greater levels of cultural connectedness.
    Time Frame
    Baseline, 12 weeks, 34 weeks
    Secondary Outcome Measure Information:
    Title
    Change in awareness of connectedness as assessed by the Awareness of Connectedness Scale
    Description
    The Awareness of Connectedness Scale is a 12-item self-report measure that evaluates awareness of connection with self, family, community, and the natural environment. Responses range from 0 (not at all) to 2 (a lot) with higher scores representing greater levels of awareness of connectedness.
    Time Frame
    Baseline, 12 weeks, 34 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ages 9-14 years Enrolled in a school where the Elders' Resilience Curriculum is delivered Participating in the Elders' Resilience Curriculum Program Exclusion Criteria: Parent/Guardian objection to youth participation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Victoria O'Keefe, PhD
    Phone
    410-955-9849
    Email
    vokeefe3@jhu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fiona Grubin, MSPH
    Phone
    406-518-1909
    Email
    fgrubin1@jhu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Victoria O'Keefe, PhD
    Organizational Affiliation
    Johns Hopkins Bloomberg School of Public Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Elders' Resilience Curriculum

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