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| ID | Type | Description | Link |
|---|---|---|---|
| 1S06GM127981 | U.S. NIH Grant/Contract | View source | |
| IRB00009500 | Other Identifier | JHSPH IRB |
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| Name | Class |
|---|---|
| Native American Research Center for Health | OTHER |
| National Institute of General Medical Sciences (NIGMS) | NIH |
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The goal of this project is to test the feasibility and acceptability of a common elements intervention delivered by community mental health workers for adults with a history of adverse childhood experiences. "Common elements" interventions build cognitive, emotional, interpersonal, and behavioral skills to help address trauma-related distress and build resilience. This will be accomplished using a randomized control trial with Apache adults ages 25-65 with recent suicidal behaviors, self-injurious behaviors, and/or binge substance use.
This is a mixed-methods study with qualitative data informing adaptation and evaluation of a common elements intervention delivered by community mental health specialists, named "My Pathway to Healing." The study includes a pilot trial and CAB discussions to inform our understanding of the feasibility of scaling up the intervention.
The investigators randomized some participants to receive the interventions and some to receive control case manager visits, to pilot what a future effectiveness RCT might be. This intervention integrates psychoeducation, relaxation techniques, problem solving and cognitive coping, and addresses safety (when identified as a problem area). The intervention used in the intervention arm of our study has been developed for the specific context and culture of White Mountain Apache.
Those randomized into the My Pathway to Healing group will receive 4-8 hour-long sessions with a community mental health specialist, taking place over 8-12 weeks. The exact number of sessions will depend on presentation and symptom level using a stepped care approach where participants receive only what they need, but the provider can provide additional sessions if needed (i.e., increased element dosage; additional optional elements for specific issues). Those randomized into the control will continue to receive the standard case management via the Apache surveillance system. These control participants will be offered the My Pathway to Healing Program upon completion of the study.
Participants will be asked to partake in 5 study assessments. For intervention participants these assessments will take place at: baseline, after their last intervention session (endline; approximately 8-12 weeks post-baseline) and 4, 8, and 12 weeks post-endline. For control participants, these assessments will take place at: baseline, 8-12 weeks post-baseline (the maximum time the intervention would last; will be referred to as an endline) and 4, 8 and 12 weeks post-endline. These assessment visits will be conducted by Research Program Assistants. Assessments will take approximately 45-90 minutes to complete. In the feasibility study, assessments are not being statistically analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sessions with a community mental health specialist | Experimental | Those randomized into the intervention group will receive 4-8 hour-long sessions with a community mental health specialist, taking place over approximately 12 weeks. The common elements treatment approach intervention (called "My Pathway to Healing") includes psychoeducation and addresses safety (when identified as a problem area). It also includes relaxation techniques, problem solving, and cognitive coping. The exact number of sessions delivered will depend on presentation and symptom level using a stepped care approach where participants receive only what they need, but the provider can provide additional sessions if needed (i.e., increased element dosage; additional optional elements for specific issues). |
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| Case management | Active Comparator | This study employs a randomized control design in which participants in the control group will receive case management and offered the intervention upon completion of their enrollment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Common Elements Treatment Approach | Behavioral | The intervention integrates psychoeducation and addresses safety (when identified as a problem area). It also includes relaxation techniques, problem solving, and cognitive coping. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Completing Visits | Feasibility as assessed by the number of participants completing sessions; 0, 0% reflects lowest feasibility, 100% reflects highest feasibility. | Up to 12 weeks post-baseline |
| Number of People Approached Who Consented or Declined | This timepoint is pre-randomization. 68 potential participants were approached to join the study; feasible if those who decline participation is less than 20%, a lower decline percentage indicates greater feasibility. A higher consent percentage indicates greater feasibility. | At consent |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Haroz, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Center for American Indian Health Whiteriver Office | Whiteriver | Arizona | 85941 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41673888 | Derived | Stifter M, Grubin F, Goklish N, Sinquah FL, Suttle R, Garcia M, Kaytoggy C, Minjarez T, Tessay R, Cwik M, Haroz EE. My Pathway to Healing (MP2H): a pilot randomized implementation trial to promote healing from the impacts of adverse childhood experiences, trauma, and suicide risk among Native American adults-trial rationale and protocol. Pilot Feasibility Stud. 2026 Feb 11;12(1):40. doi: 10.1186/s40814-026-01779-w. |
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Data collected as part of this project is protected by tribal sovereignty. Any requests for data sharing must be approved by all relevant tribal authorities (tribal council, health board, etc.) before data can be shared.
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The study consented n=36 adults, then n=5 were lost to followup (LTFU) before baseline assessment; n=31 completed baseline assessment and were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sessions With a Community Mental Health Specialist | Those randomized into the intervention group will receive 4-8 hour-long sessions with a community mental health specialist, taking place over approximately 12 weeks. The common elements treatment approach intervention (called "My Pathway to Healing") includes psychoeducation and addresses safety (when identified as a problem area). It also includes relaxation techniques, problem solving, and cognitive coping. The exact number of sessions delivered will depend on presentation and symptom level using a stepped care approach where participants receive only what they need, but the provider can provide additional sessions if needed (i.e., increased element dosage; additional optional elements for specific issues). Common Elements Treatment Approach: The intervention integrates psychoeducation and addresses safety (when identified as a problem area). It also includes relaxation techniques, problem solving, and cognitive coping. |
| FG001 | Case Management | This study employs a randomized control design in which participants in the control group will receive case management and offered the intervention upon completion of their enrollment period. Common Elements Treatment Approach: The intervention integrates psychoeducation and addresses safety (when identified as a problem area). It also includes relaxation techniques, problem solving, and cognitive coping. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sessions With a Community Mental Health Specialist | Those randomized into the intervention group will receive 4-8 hour-long sessions with a community mental health specialist, taking place over approximately 12 weeks. The common elements treatment approach intervention (called "My Pathway to Healing") includes psychoeducation and addresses safety (when identified as a problem area). It also includes relaxation techniques, problem solving, and cognitive coping. The exact number of sessions delivered will depend on presentation and symptom level using a stepped care approach where participants receive only what they need, but the provider can provide additional sessions if needed (i.e., increased element dosage; additional optional elements for specific issues). Common Elements Treatment Approach: The intervention integrates psychoeducation and addresses safety (when identified as a problem area). It also includes relaxation techniques, problem solving, and cognitive coping. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Completing Visits | Feasibility as assessed by the number of participants completing sessions; 0, 0% reflects lowest feasibility, 100% reflects highest feasibility. | Posted | Count of Participants | Participants | Up to 12 weeks post-baseline |
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Up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sessions With a Community Mental Health Specialist | Those randomized into the intervention group will receive 4-8 hour-long sessions with a community mental health specialist, taking place over approximately 12 weeks. The common elements treatment approach intervention (called "My Pathway to Healing") includes psychoeducation and addresses safety (when identified as a problem area). It also includes relaxation techniques, problem solving, and cognitive coping. The exact number of sessions delivered will depend on presentation and symptom level using a stepped care approach where participants receive only what they need, but the provider can provide additional sessions if needed (i.e., increased element dosage; additional optional elements for specific issues). Common Elements Treatment Approach: The intervention integrates psychoeducation and addresses safety (when identified as a problem area). It also includes relaxation techniques, problem solving, and cognitive coping. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Binge substance use | Social circumstances | Systematic Assessment | Participant had binge substance use reported |
Investigators received sponsor approval to transition the randomized control trial to a feasibility study with smaller sample size. Investigators aimed to recruit 30 participants and understand the feasibility of scaling this study at a larger size and understand the challenges of implementing this intervention with this population of adults experiencing suicide, self-injury, and substance use. The rest of the study design, aside from the sample size, remained the same throughout the project.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily E. Haroz, PhD, Co-Director of Research | Johns Hopkins Center for Indigenous Health | 410-960-9503 | eharoz1@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 27, 2025 | Mar 31, 2025 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 27, 2022 | Apr 22, 2025 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D014947 | Wounds and Injuries |
| D063425 | Binge Drinking |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019973 | Alcohol-Related Disorders |
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Investigators will use a randomized control design.
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| BG001 | Case Management | This study employs a randomized control design in which participants in the control group will receive case management and offered the intervention upon completion of their enrollment period. Common Elements Treatment Approach: The intervention integrates psychoeducation and addresses safety (when identified as a problem area). It also includes relaxation techniques, problem solving, and cognitive coping. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Index event behavior | Participants were eligible for the study with self-injury, binge substance use, suicide ideation or attempt. | Count of Participants | Participants |
|
| OG001 | Case Management | This study employs a randomized control design in which participants in the control group will receive case management and offered the intervention upon completion of their enrollment period. Common Elements Treatment Approach: The intervention integrates psychoeducation and addresses safety (when identified as a problem area). It also includes relaxation techniques, problem solving, and cognitive coping. |
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| Primary | Number of People Approached Who Consented or Declined | This timepoint is pre-randomization. 68 potential participants were approached to join the study; feasible if those who decline participation is less than 20%, a lower decline percentage indicates greater feasibility. A higher consent percentage indicates greater feasibility. | Potential participants approached | Posted | Count of Participants | Participants | At consent |
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|
|
| 1 |
| 15 |
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | Case Management | This study employs a randomized control design in which participants in the control group will receive case management and offered the intervention upon completion of their enrollment period. Common Elements Treatment Approach: The intervention integrates psychoeducation and addresses safety (when identified as a problem area). It also includes relaxation techniques, problem solving, and cognitive coping. | 0 | 16 | 0 | 16 | 2 | 16 |
|
| Suicide ideation | Psychiatric disorders | Systematic Assessment | Suicide ideation reported |
|
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| D019966 |
| Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D000428 | Alcohol Drinking |
| D004327 | Drinking Behavior |
| D001523 | Mental Disorders |