An interventional study of Common Elements Treatment Approach in Suicide; Trauma and Binge Drinking, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in United States. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Treatment
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.
607 studies on the registry are indexed under Suicide; 162 are open to participants now.
This study's enrollment of 36 is below the median of 104 across 490 interventional studies indexed under Suicide.
Browse Suicide studies →Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 371 studies on the registry; 42 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Compared within Suicide, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Behavioral: Common Elements Treatment Approach
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.
Behavioral: 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.
Number of Participants Completing Visits
Feasibility as assessed by the number of participants completing sessions; 0, 0% reflects lowest feasibility, 100% reflects highest feasibility.
Time frame: 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.
Time frame: At consent
| Milestone | Sessions With a Community Mental Health Specialist | Case Management |
|---|---|---|
| Started | 15 | 16 |
| Completed | 7 | 11 |
| Not completed | 8 | 5 |
| Withdrew: Lost to follow-up | 8 | 5 |
Feasibility as assessed by the number of participants completing sessions; 0, 0% reflects lowest feasibility, 100% reflects highest feasibility.
| Participants | Sessions With a Community Mental Health Specialist | Case Management |
|---|---|---|
| Number of Participants Completing Visits | 7 | 11 |
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.
| Participants | Declined | Consented |
|---|---|---|
| Number of People Approached Who Consented or Declined | 32 | 36 |
Collected over Up to 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sessions With a Community Mental Health Specialist | 1/15 (6.7%) | 0/15 (0%) | 1/15 (6.7%) |
| Case Management | 0/16 (0%) | 0/16 (0%) | 2/16 (12.5%) |
| Event | Sessions With a Community Mental Health Specialist | Case Management |
|---|---|---|
| Binge substance useSocial circumstances | 0/15 | 2/16 |
| Suicide ideationPsychiatric disorders | 1/15 | 0/16 |
| Age, Categorical(Participants) | Sessions With a Community Mental Health Specialist | Case Management | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 16 | 31 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Sessions With a Community Mental Health Specialist | Case Management | Total |
|---|---|---|---|
| Female | 7 | 4 | 11 |
| Male | 8 | 12 | 20 |
| Race (NIH/OMB)(Participants) | Sessions With a Community Mental Health Specialist | Case Management | Total |
|---|---|---|---|
| American Indian or Alaska Native | 15 | 16 | 31 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Sessions With a Community Mental Health Specialist | Case Management | Total |
|---|---|---|---|
| United States | 15 | 16 | 31 |
| Index event behavior(Participants) | Sessions With a Community Mental Health Specialist | Case Management | Total |
|---|---|---|---|
| Binge substance use | 5 | 8 | 13 |
| Self-injury | 1 | 1 | 2 |
| Suicide ideation | 7 | 6 | 13 |
| Suicide attempt | 2 | 1 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Johns Hopkins Bloomberg School of Public Health →