Suicide; TraumaMP2HNCT04585906
My Pathway to Healing
A study testing Common Elements Treatment Approach in people with Suicide; Trauma and Binge Drinking, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Suicide; Trauma, Binge Drinking
- What is being tested?
- Common Elements Treatment Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2022to 12 Nov 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 25-65
- Suicide ideation, suicide attempt, self-injurious behavior, and/or binge alcohol and/or drug use within past 90 days confirmed by the Apache suicide surveillance system
- Experienced at least 2 adverse childhood experiences
- Native American
- Reside on or near the Fort Apache Indian Reservation.
- An average score of 1 or above on a measure of symptoms of posttraumatic stress
Who cannot join
- Unable to provide informed consent
- Have a serious developmental disorder
- Have active psychosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Center for American Indian Health Whiteriver Office
Whiteriver, Arizona, 85941
About this study
Official title: My Pathway to Healing: Adaptation and Testing of a Common Elements Treatment Approach to Address Trauma, Suicide Ideation and Substance Abuse
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.
Read the detailed description
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.
- Conditions
- Suicide; Trauma, Binge Drinking
- Being tested
- Common Elements Treatment Approach
- Medical subject headings
- Suicide, Wounds and Injuries, Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Common Elements Treatment ApproachBehavioural
The intervention integrates psychoeducation and addresses safety (when identified as a problem area). It also includes relaxation techniques, problem solving, and cognitive coping.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Common Elements Treatment Approach |
| 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. Receives: Behavioral: Common Elements Treatment Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Completing Visits
Feasibility as assessed by the number of participants completing sessions; 0, 0% reflects lowest feasibility, 100% reflects highest feasibility.
Measured: 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.
Measured: At consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start19 Jul 2022
- Primary completion28 Mar 2024
- Study completion12 Nov 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicide; TraumaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigators will use a randomized control design.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Native American Research Center for Health, National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Emily Haroz, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585906
- Sponsor's protocol ID
- JHSPH-9500
- Other IDs
- 1S06GM127981, IRB00009500
- Acronym
- MP2H
- Status last verified
- Apr 2025
- First submitted
- 26 Aug 2020
- Last updated
- 24 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 41673888
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Pathway to Healing: Adaptation and Testing of a Common Elements Treatment Approach to Address Trauma, Suicide Ideation and Substance Abuse
- ClinicalTrials.gov ID
- NCT04585906
- Acronym / sponsor ID
- MP2H / JHSPH-9500
- Conditions
- Suicide; Trauma, Binge Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Native American Research Center for Health, National Institute of General Medical Sciences (NIGMS)
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Posted 24 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Investigators will use a randomized control design.
| Arm | Type | Receives |
|---|---|---|
| Sessions with a community mental health specialist | Experimental | Behavioral: Common Elements Treatment ApproachThose 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). |
| Case management | Active comparator | Behavioral: Common Elements Treatment ApproachThis 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 25-65
- Suicide ideation, suicide attempt, self-injurious behavior, and/or binge alcohol and/or drug use within past 90 days confirmed by the Apache suicide surveillance system
- Experienced at least 2 adverse childhood experiences
- Native American
- Reside on or near the Fort Apache Indian Reservation.
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- Have a serious developmental disorder
- Have active psychosis
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 |
|---|---|---|
| Common Elements Treatment ApproachThe intervention integrates psychoeducation and addresses safety (when identified as a problem area). It also includes relaxation techniques, problem solving, and cognitive coping. | Behavioural | Case management, Sessions with a community mental health specialist |
Primary outcome
Number of Participants Completing Visits
Time frame: Up to 12 weeks post-baseline
Feasibility as assessed by the number of participants completing sessions; 0, 0% reflects lowest feasibility, 100% reflects highest feasibility.
Number of People Approached Who Consented or Declined
Time frame: At consent
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41673888Stifter 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.
- Individual participant dataSharing planned: No. 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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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.
Emily Haroz, 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 Common Elements Treatment Approach in people with Suicide; Trauma and Binge Drinking, 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 6 inclusion and 3 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 24 Apr 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 24 Apr 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?
Number of Participants Completing Visits (time frame: Up to 12 weeks post-baseline). 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?
On the ClinicalTrials.gov record for NCT04585906, which also lists 1 linked publication.
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 24 Apr 2025.