My Pathway to Healing

NCT04585906 | Completed Results

• 3 other identifiers: JHSPH-95001S06GM127981IRB00009500
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. "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.

Conditions

Suicide; Trauma; Binge Drinking

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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).

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.

Behavioral: Common Elements Treatment Approach

Interventions

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.

Case management; Sessions with a community mental health specialist

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to provide informed consent
• Have a serious developmental disorder
• Have active psychosis

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Native American Research Center for Health: collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Johns Hopkins Center for American Indian Health Whiteriver Office

Whiteriver, Arizona, 85941, United States

Location

MeSH Terms

Conditions

Suicide; Wounds and Injuries; Binge Drinking

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol Drinking; Drinking Behavior; Mental Disorders

Limitations and Caveats

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.

Results Point of Contact

• Title: Emily E. Haroz, PhD, Co-Director of Research
• Organization: Johns Hopkins Center for Indigenous Health

eharoz1@jhu.edu

410-960-9503

Study Officials

• Emily Haroz, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Investigators will use a randomized control design.

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: October 14, 2020
• Study Start: July 19, 2022
• Primary Completion: March 28, 2024
• Study Completion: November 12, 2024
• Last Updated: April 24, 2025
• Results First Posted: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)