Using Ecological Momentary Data to Inform a Web Intervention for Romantic Partners Concerned About Their Loved Ones' Drinking

NCT06670794 | Not Yet Recruiting

• 2 other identifiers: IRB2024012221R34AA030182-01A1
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim 1. Couples (N=50 dyads) with a Concerned Partner (CP) and a Drinking Partner (DP) will independently complete baseline and follow-up surveys and a 21-day EMA with three daily reports on their communication and DP's drinking. Aim 2. Iteratively develop a four-session web based intervention and evaluate the WBI's feasibility and acceptability with 15 CPs. Aim 3. Perform a pilot randomized controlled trial (RCT) comparing WBI to psychoeducation control in 110 couples.

Conditions

Experimental; Control Condition

Keywords

alcohol; alcohol use disorder; community reinforcement and family training; concerned partners; concerned significant others; communication

Outcome Measures

Primary Outcomes (11)

• CP Depression Symptoms Questionnaire

  Patient Health Questionnaire. 8 items. Scores range from 0-32. Higher scores indicate more depressive symptoms.

  1 month post-intervention.

• CP Anxiety Symptoms Questionnaire

  Generalized Anxiety Disorder scale. 7 items. Higher scores indicate more anxiety symptoms.

  1 month post-intervention.

• CP Anger expression questionnaire

  Dimensions of Anger Reactions - 5 item (DAR-5). Scores range 1-5 with higher scores indicating greater anger.

  1 month post-intervention.

• CP Loneliness Questionnaire

  Measure: UCLA 3-item Loneliness Scale (Hughes, M. E., Waite, L. J., Hawkley, L. C., \& Cacioppo, J. T. (2004). A Short Scale for Measuring Loneliness in Large Surveys. Research on Aging, 26(6), 655-672. https://doi.org/10.1177/0164027504268574) Scores are 1-9. Higher scores indicate more loneliness.

  1 month post-intervention.

• CP Partner Social Support Questionnaire

  Marital Perceived Social Support (Cohen et al., 1985). Scored 0-3. Higher scores mean more social support.

  1 month post-intervention.

• CP-DP Relationship Functioning Questionnaire

  Quality of Marriage Index (Norton, 1983). Higher scores indicate greater relationship satisfaction.

  1 month post-intervention.

• DP AUDIT Questionnaire

  Drinking Partner's AUDIT score. 10 items. Items are summed. Greater scores indicate greater alcohol use.

  1 month post-intervention.

• CP General Social Support Questionnaire

  MOS Social Support Survey (Sherbourne \& Stewart, 1991). Scored 1-5. Higher scores indicate more social support. Sherbourne, C. D., \& Stewart, A. L. (1991). The MOS social support survey. Social science \& medicine, 32(6), 705-714.

  1 month post-intervention.

• DP Alcohol Use Questionnaire

  Drinking Partner's: Alcohol consumption via the Quantity/Frequency/Peak Alcohol Use Index (Dimeff et al., 1991). Six items measure the drinking partner's alcohol consumption. The items are not scored together but evaluated individually (e.g., frequency, typical quantity, peak quantity, etc.). Higher scores denote greater consumption.

  1 month post-intervention.

• DP Drinking Motives Questionnaire

  Drinking Partner's Drinking Motives using the Drinking Motives Questionnaire (Cooper et al., 1992). Subscales for coping, enhancement, social, and conformity. Items are averaged. Higher scores indicate greater endorsement of that motive.

  1 month post-intervention.

• DP Alcohol-related Consequences Questionnaire

  Drinking Partner's Alcohol-related Consequences assess via the Brief Young Adult Alcohol Related Consequences measure. 24 items. Scores are created by summing the items. Higher scores denote greater consequences endorsed.

  1 month post-intervention.

Secondary Outcomes (4)

• CP-DP Communication Questionnaire

  1 month post-intervention.

• CP-DP Perceived Partner Responsiveness Questionnaire

  1 month post-intervention.

• CP Communication about Drinking Questionnaire

  1 month post-intervention.

• CP-DP Communication: Number of conflicts

  1 month post-intervention.

Study Arms (2)

Psychoeducation control

OTHER

Psychoeducation control CPs will be routed to visit self-help resources on NIAAA's website ("Alcohol's Effects on Health") and asked to spend the same amount of time (20-30 minutes) reviewing site content.

Behavioral: Psychoeducation control

Experimental web-based intervention

EXPERIMENTAL

CPs in the experimental web-based intervention condition will complete web-based sessions including personalized feedback and information about how communication and self-care affect their own well-being and their partner's alcohol use behaviors.

Behavioral: Web-based intervention for concerned partners

Interventions

Web-based intervention for concerned partners BEHAVIORAL

The web-based intervention will comprise sessions focusing on community reinforcement and family therapy principles including: (1) self-care, (2) positive communication including ways to increase responsiveness to their partner (PPR; i.e., actively listening, showing understanding, expressing interest in what their partner is thinking and feeling, and trying to see where their partner is coming from), (3) understanding their partner's drinking reinforcers, and (4) supporting their partner if they want help and engaging in positive, healthy activities with their partner.

Experimental web-based intervention

Psychoeducation control BEHAVIORAL

This is a psychoeducation control condition.

Psychoeducation control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be at least 18 years old
• be in a romantic relationship with their partner
• be living with their partner,
• have a computer, tablet, or mobile phone with Internet access
• have no plans to separate from their partner in the next 60 days
• indicate no concerns they would be physically hurt by their partner on the Intimate Partner Screen

You may not qualify if:

• drinking scores at or above the threshold for DP participation
• be at least 18 years old
• misuses alcohol as defined by their scores (4+ for women/non-gender confirming, 5+ for men) on the consumption portion of the Alcohol Use Disorder Identification Test (AUDIT-C) (Dawson et al., 2005)
• has a computer, tablet, or mobile phone with Internet access
• indicates no concerns they would be physically hurt by their partner
• current alcohol treatment
• currently concerned about their partner's drinking

Sponsors & Collaborators

• Stanford University: collaborator
• Portland State University: collaborator
• University of Florida: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

MeSH Terms

Conditions

Alcoholism; Communication

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Lindsey Rodriguez, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsey Rodriguez, Ph.D.

CONTACT

650-613-3484; lmrodriguez@ufl.edu

Karen Osilla, Ph.D.

CONTACT

kosilla@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 1, 2024
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 30, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available within 2 years of the award end date, as required by the NIAAA Data Archive. Data will also be grouped based on publication, which will be shared when the pre-print is available. These publications will have DOIs to aid in findability. Raw data will include a GUID to help with indexing. The NIAAA Data Archive will make decisions about how long to preserve data.
• Access Criteria: Any scientific researcher may access our de-identified data, as consistent with the NIAAA Data Archive. To request access of the data, researchers will use the standard processes for the NIAAA Data Archive, and the Data Access Committee will decide which requests to grant. The standard NIAAA data access process allows access for one year and is renewable. Data will be findable for the research community through utilization of the NIAAA Data Archive, which is a public data repository housed under the NIMH. All participants will be assigned a GUID to allow for standard indexing. Research publications and manuscripts will be assigned a digital object identifier (DOI), which will be referenced in the data, to allow for the research community to access the exact information used for this publication.