The purpose of this clinical trial is to develop and test whether a text- and web-based tool called FamilyCHESS - designed for individuals with opioid use disorder (OUD) and a concerned significant other (CSO) - can help the identified patient (IP) begin and stay on medication for opioid use disorder (MOUD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
338
Participants will have access to the FamilyCHESS system on their personal smartphone. FamilyCHESS incorporates Invitation to Change (ITC), a combination of Community Reinforcement and Family Training (CRAFT), Acceptance and Commitment Therapy (ACT), and Motivational Interviewing (MI) training principles and components for a CSO (e.g., parent, spouse/romantic partner, adult child, other family member or friend) to encourage and support the patient to engage in treatment.
Participants will receive links to Substance Abuse and Mental Health Services Administration (SAMHSA) resources for MOUD
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
University of Wisonsin-Madison
Madison, Wisconsin, United States
Initiation of MOUD
Number of days between study start date and MOUD initiation date.
Time frame: 12 months
Continuity on MOUD
Collected through self-report. Percentage of days IPs in the intervention arm are on MOUD compared to control arm.
Time frame: 4, 8, and 12 months
Change in IP Quality of Life
Quality of life (QOL) is measured using the SF-12 Health Survey, which is a 12-item questionnaire. It is scored on a variable Likert scale. Scores range from 12 to 47 where higher scores indicate greater quality of life.
Time frame: Baseline, 4, 8, and 12 months
Change in number of opioid overdoses
IPs will self-report whether, and how many, overdoses they experienced in the previous 30 days. An opioid overdose occurs when someone turns blue, has little or no breathing, or passes out and cannot be woken up without help after using opioids.
Time frame: Baseline, 4, 8, and 12 months
Change in number of emergency room visits
Time frame: Baseline to 12 months
Change in percentage of days of opioid use
IPs will self-report the number of days they used any illegal/street drugs, abuse any prescription medications, or drink alcohol over the previous 30 days. It will be reported as a percentage of overall days of use
Time frame: Baseline, 4, 8, and 12 months
Change in McMaster Family Functioning Scale (FAD-GF)
FAD-GF is a 12 item questionnaire using a 4-point Likert scale. 1 = strongly agree and 4 = strongly disagree. Odd items are reverse scored. Once the odd items have been reverse scored the participant's family functioning score is the sum of the 12 items, which ranges from 12-48, where higher scores indicate better family functioning.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline, 4, 8, and 12 months
Change in CSO coping styles
CSOs will complete a 30-item survey about coping strategies. It is scored on a 3-point Likert scale where no = 0 and often = 3. Scores range from 0-90, where higher scores indicate better coping strategies.
Time frame: Baseline, 4, 8, and 12 months
Change in CSO perceptions of social support
Using the Alcohol, Drugs and the Family Support Scale, CSOs will rate their perception of social support. The scale is a 25 item survey which uses a 3-point Likert scale where 0 = never and 3 = often (some items are reverse scored). Scores range from 0-75. Higher scores indicate greater sense of support.
Time frame: Baseline, 4, 8, and 12 months
Change in CSO Quality of Life
QOL is measured using the SF-12 Health Survey, which is a 12-item questionnaire. It is scored on a variable Likert scale. Scores range from 12 to 47 where higher scores indicate greater quality of life.
Time frame: Baseline, 4, 8, and 12 months