NCT04585906: MP2H

My Pathway to Healing

Completed NA Results posted Last updated 24 April 2025

What this trial tests

NA trial testing Common Elements Treatment Approach in Suicide; Trauma in 36 participants. Completed in 12 November 2024.

Timeline

19 July 2022

Primary endpoint
28 March 2024

12 November 2024

Quick facts

Lead sponsor	Johns Hopkins Bloomberg School of Public Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	19 July 2022
Primary completion	28 March 2024
Estimated completion	12 November 2024
Sites	1 location across United States

Drugs / interventions tested

• Common Elements Treatment Approach

Conditions studied

• Suicide; Trauma — all drugs for Suicide; Trauma →
• Binge Drinking — all drugs for Binge Drinking →

Sponsor

Johns Hopkins Bloomberg School of Public Health

Who can join

Adults 25 to 65, any sex, with Suicide; Trauma or Binge Drinking. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Completing Visits Primary · 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.

Group	Value	95% CI
Sessions With a Community Mental Health Specialist	7
Case Management	11

Number of People Approached Who Consented or Declined Primary · 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.

Group	Value	95% CI
Declined	32
Consented	36

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sessions With a Community Mental Health Specialist

Serious: 0/15 (0%)

Deaths: 1/15

Case Management

Serious: 0/16 (0%)

Deaths: 0/16

Other adverse events (2 terms — click to expand)

Reaction	System	Sessions With a Community …	Case Management
Binge substance use	Social circumstances	—	—
Suicide ideation	Psychiatric disorders	—	—

Data from ClinicalTrials.gov NCT04585906 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Stifter M, Grubin F, Goklish N, Sinquah FL, et al · · 2026 · PMID 41673888 · DOI 10.1186/s40814-026-01779-w