Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19

Study Overview
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Brief Summary
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this R01 project titled Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19 is a Hybrid II RCT/implementation study to modify and test two of our alcohol smartphone interventions to address the fallout from COVID. We propose a three-arm RCT comparing a smartphone control group vs. a drinker-focused intervention vs. a family-focused intervention. All study arms recruit dyads comprising a person who drinks and a family partner.

Official Title
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Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19

Conditions
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Alcohol Use Disorder, Family Members, Behavior, Addictive

Intervention / Treatment
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* Behavioral: PartnerCHESS
* Behavioral: ACHESS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Drinkers and their family partners must give informed consent; agree to complete interviews at baseline, 4, 8, and 12 months; and not have a mental or physical condition that limits smartphone use. Drinkers must be age 18 or older and meet criteria for risky drinking (for men, >14 standard drinks in a week or >4 in a day; for women, >7 in a week or >3 in a day),76 or meet criteria for AUD (any severity) defined by DSM-5 and have had at least 1 drink in the past 3 months .77 Partner must be a committed romantic partner, spouse, or family member (e.g. sibling, parent, grandparent, adult child age 21 or older). Exclusion Criteria: Current (last 6 months) evidence of unstabilized serious mental illness (active psychosis, delusions, hallucinations, active manic phase). We will also exclude dyads if either partner reports serious interpersonal violence in the past year, because of potential safety risk owing to access to a partner's smartphone or computer.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ACHESS-C<br>In ACHESS-C, both the drinker and the partner will receive a smartphone, but only the drinker will receive the ACHESS-C app. The partner will receive a smartphone with contact information for standard AUD, SUD, and crisis support. | Behavioral: ACHESS<br>* ACHESS-C offers the following, which are also available in FamCHESS-C: Covid content, Instant Library, Discussion Groups, Personal Stories, Location Monitor, Surveys and Ecological Momentary Assessments, Guided Relaxation, Healthy Activities, Crisis Button, Skills Reminders<br>|
| Experimental: FamCHESS-C<br>In the FamCHESS-C arm, drinker and partner will both receive a smartphone with the FamCHESS-C app, which contains ACHESS-C services plus ABCT/ PartnerCHESS services. | Behavioral: PartnerCHESS<br>* The following ABCT services, from PartnerCHESS, will be available in the FamCHESS-C app but not in ACHESS-C: ABCT tutorials. Interactive e-learning modules explaining key ABCT skills. Agreements between drinker and partner to follow key principles. Trigger identification and removal. Cravings discussion. Relapse plan. Reminders.<br>|
| No Intervention: Control<br>Both the drinker and family partner will receive a smartphone with pre-programmed contact information for Alcoholics Anonymous (AA), Narcotics Anonymous (NA), Al-Anon, Adult Children of Alcoholics (ACOA), and crisis hot lines. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of patient risky drinking days | Risky drinking day will be defined as greater than 4 drinks for men and greater than 3 drinks for women in 2 hours and will be measured through the Timeline Followback every 120 days. | Baseline, 4, 8, and 12 months | 
| Change in psychological distress | The OQ45 measures the patient's and partner's outcomes during treatment by assessing three sub-domains, Symptom Distress, Interpersonal Relations, and Social Role. Scores from the Outcomes Questionnaire-45 range from 0-180, the higher the score, the higher the symptoms of distress | Baseline, 4, 8, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in % days drinking & other drug use | % days drinking & other drug use will be measured through the Timeline Followback every 120 days. | Baseline, 4, 8, and 12 months | 
| Change in no risky drinking days | No risky drinking days will be measured through the Timeline Followback every 120 days. | Baseline, 4, 8, and 12 months | 
| Change in number of alcohol problems | The Short Inventory of Problems (SIP) assess consequences of drinking and is based on the Drinker Inventory of Consequences and measures consequences in 5 domains: interpersonal, intrapersonal, physical, impulse control, and social. Respondents indicate whether each item occurred in the last 30 days. Responses are summed across the 15 items to yield a total score. The higher the number the greater degree of consequences being experienced by the drinker. | Baseline, 4, 8, and 12 months | 
| Change in couple alcohol-related communication | The 20-item Partner Interaction Questionnaire (PIQ-20) will be used to assess social support for adults wanting to stop drinking. | Baseline, 4, 8, and 12 months | 
| Change in relationship satisfaction | Determined by use of the Dyadic Adjustment Scale - 7 (DAS-7) which is a brief version of the 32 question Dyadic Adjustment Scale (DAS) and assesses the quality of marriage and similar dyads. The DAS-7 includes 4 subscales: Affectional Expression where the total range of scores is 0-12, the higher the score, the higher the affection; Cohesion subscale ranging from 0-24, the higher the score the more cohesive a relationship is; Consensus subscale ranging from 0-65, the higher the score the more consensus in the relationship; and the Satisfaction subscale ranging from 0-51, the higher the score the more satisfying the relationship. | Baseline, 4, 8, and 12 months | 
| Change in depressive symptoms | The PHQ-8 is the depression module, which scores each of the eight DSM-IV criteria as 0 (not at all) to 3 (nearly every day). It has been validated for use in primary care. It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment. | Baseline, 4, 8, and 12 months | 
| Change in partner abusive behaviors | A 15-item version of the Composite Abuse Scale (Revised)-Short Form, CASR-SF is brief self-report measure of IPV experiences among women that has demonstrated initial reliability and validity and is suitable for use in population studies or other studies. | Baseline, 4, 8, and 12 months | 
| Change in Covid Vaccination/Infection | 2 questions asking if the individual has been vaccinated or had covid greater then 4 months ago. | Baseline, 4, 8, and 12 months |