Suicide; Trauma, Binge Drinking
Conditions
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.
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.
Interventions
BEHAVIORALCommon 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.
Sponsors
Native American Research Center for Health
National Institute of General Medical Sciences (NIGMS)
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Investigators will use a randomized control design.
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Unable to provide informed consent * Have a serious developmental disorder * Have active psychosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Completing Visits | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 16 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 5 |
Baseline characteristics
| Characteristic | Sessions With a Community Mental Health Specialist | Case Management | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 16 Participants | 31 Participants |
| Index event behavior Binge substance use | 5 Participants | 8 Participants | 13 Participants |
| Index event behavior Self-injury | 1 Participants | 1 Participants | 2 Participants |
| Index event behavior Suicide attempt | 2 Participants | 1 Participants | 3 Participants |
| Index event behavior Suicide ideation | 7 Participants | 6 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 15 Participants | 16 Participants | 31 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 8 Participants | 12 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 15 | 0 / 16 |
| other Total, other adverse events | 1 / 15 | 2 / 16 |
| serious Total, serious adverse events | 0 / 15 | 0 / 16 |
Outcome results
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.
Time frame: Up to 12 weeks post-baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sessions With a Community Mental Health Specialist | Number of Participants Completing Visits | 7 Participants |
| Case Management | Number of Participants Completing Visits | 11 Participants |
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.
Time frame: At consent
Population: Potential participants approached
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sessions With a Community Mental Health Specialist | Number of People Approached Who Consented or Declined | 32 Participants |
| Case Management | Number of People Approached Who Consented or Declined | 36 Participants |