Suicidal IdeationNCT06045273
The Elders' Resilience Curriculum
A study testing Elders' Resilience Curriculum in people with Suicidal Ideation, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Elders' Resilience Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to 16 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 9-14 years
- Enrolled in a school where the Elders' Resilience Curriculum is delivered
- Participating in the Elders' Resilience Curriculum Program
Who cannot join
- Parent/Guardian objection to youth participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Elders' Resilience Curriculum: Toward Building Empirical Evidence Around a Culturally-Grounded, Strengths-Based Intervention
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.
Read the 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.
- Conditions
- Suicidal Ideation
- Being tested
- Elders' Resilience Curriculum
- Keywords
- American Indian, Alaska Native, Suicide prevention
- Medical subject headings
- Suicidal Ideation, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elders' Resilience CurriculumBehavioural
Also called ERC
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
| Study group | Role | What they receive |
|---|---|---|
| Elders' Resilience Curriculum Recipients | Experimental | Youth aged 9-14 who receive the Elders' Resilience Curriculum Receives: Behavioral: Elders' Resilience Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 1 (not at all) to 3 (a lot) with higher scores indicating more reasons for life. Total scores range from 11-33 with higher scores indicating more reasons for life. Change was calculated from the difference between endline and baseline responses.
Measured: Baseline, 26 weeks
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 1 (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. Total scores range from 0-12 with higher scores indicating greater levels of cultural connectedness. Change was calculated from the difference between endline and baseline responses.
Measured: Baseline, 26 weeks
Secondary outcomes (1)
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. Total scores range from 0-24 with higher scores representing greater levels of awareness of connectedness. Change was calculated from the difference between endline and baseline responses.
Measured: Baseline, 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start15 Nov 2023
- Primary completion16 May 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Victoria O'Keefe, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045273
- Sponsor's protocol ID
- IRB00018615
- Other IDs
- K01MH122702
- Status last verified
- May 2025
- First submitted
- 13 Sep 2023
- Last updated
- 4 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Elders' Resilience Curriculum: Toward Building Empirical Evidence Around a Culturally-Grounded, Strengths-Based Intervention
- ClinicalTrials.gov ID
- NCT06045273
- Acronym / sponsor ID
- IRB00018615
- Conditions
- Suicidal Ideation
- Keywords
- American Indian, Alaska Native, Suicide prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Posted 4 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elders' Resilience Curriculum Recipients | Experimental | Behavioral: Elders' Resilience CurriculumYouth aged 9-14 who receive the Elders' Resilience Curriculum |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Ages 9-14 years
- Enrolled in a school where the Elders' Resilience Curriculum is delivered
- Participating in the Elders' Resilience Curriculum Program
Key exclusion criteria (1 listed)
- Parent/Guardian objection to youth participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elders' Resilience CurriculumAlso: ERCThe 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 | Behavioural | Elders' Resilience Curriculum Recipients |
Primary outcome
Change in Reasons for Life as Assessed by the Reasons for Life Scale
Time frame: Baseline, 26 weeks
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 1 (not at all) to 3 (a lot) with higher scores indicating more reasons for life. Total scores range from 11-33 with higher scores indicating more reasons for life. Change was calculated from the difference between endline and baseline responses.
Change in Cultural Connectedness as Assessed by the Cultural Connectedness Scale - Short Form
Time frame: Baseline, 26 weeks
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 1 (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. Total scores range from 0-12 with higher scores indicating greater levels of cultural connectedness. Change was calculated from the difference between endline and baseline responses.
1 secondary outcome
Change in Awareness of Connectedness as Assessed by the Awareness of Connectedness Scale
Time frame: Baseline, 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria O'Keefe, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elders' Resilience Curriculum in people with Suicidal Ideation, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Reasons for Life as Assessed by the Reasons for Life Scale (time frame: Baseline, 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025; AzTrials last refreshed its copy on 27 Oct 2026.