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ExperimentalNCT06670794

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

A study testing Web-based intervention for concerned partners in people with Experimental and Control Condition, run by University of Florida.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Experimental, Control Condition
What is being tested?
Web-based intervention for concerned partners
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
No sites listed yet
Study dates
29 Sep 2026to 28 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

CP Inclusion Criteria:

  • 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

CP Exclusion Criteria:

  • drinking scores at or above the threshold for DP participation

DP Inclusion Criteria:

  • 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

DP Exclusion Criteria:

  • current alcohol treatment
  • currently concerned about their partner's drinking

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Lindsey Rodriguez, Ph.D. contact

650-613-3484

lmrodriguez@ufl.edu

Karen Osilla, Ph.D. contact

kosilla@stanford.edu

About this study

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.

Read the detailed description

Alcohol misuse negatively affects relationships and is significantly correlated with higher rates of relationship conflict, distress, and dissolution as well as other serious negative interpersonal consequences (e.g., domestic violence, sexual assaults). Encouragement from concerned partners (CPs) is a common motivator for those who misuse alcohol to pursue care and often the most helpful mechanism in supporting change. The goals of this proposal are to: Identify how specific CP behaviors influence their partner's alcohol craving, motives, drinking, and problems on a daily basis using dyadic ecological momentary assessment techniques (Aim 1); use the knowledge from EMA analysis to iteratively develop a CP-focused web-based intervention (WBI) that provides psychoeducation about communication patterns that influence DP drinking and by integrating personalized feedback about CPs' own communication behaviors that may be working against their goals (Aim 2); and pilot the WBI's efficacy on CP outcomes (depression, anxiety, social support), their partner's drinking behavior (alcohol consumption, motives, related consequences), and both partners' relationship distress and conflict (Aim 3). The investigators expect the WBI will yield significant improvements in all outcomes. This project is significant because intervening with CPs has strong potential to change relationship dynamics that may reduce problems and prevent future problems associated with alcohol misuse. It also develops a new prevention model that does not rely on the drinking partner attending a clinical facility to access care. The proposed study is innovative because it uses dyadic and ecological momentary assessment designs to test dynamic questions about interdependence in relationship interactions and alcohol use between partners and employs the generated knowledge to inform intervention adaptation. Teaching CPs to effectively communicate their concerns may be a necessary catalyst for decreasing their partner's alcohol use and preventing alcohol use disorders. The potential reach of this intervention is large such that it can be easily implemented over the web to those who may need help but would not otherwise seek care.

Being tested
Web-based intervention for concerned partners, Psychoeducation control
Keywords
alcohol, alcohol use disorder, community reinforcement and family training, concerned partners, concerned significant others, communication
Medical subject headings
Alcoholism, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Web-based intervention for concerned partnersBehavioural

    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.

  • Psychoeducation controlBehavioural

    This is a psychoeducation control condition.

Study groups in NCT06670794
Study groupRoleWhat they receive
Psychoeducation controlOtherPsychoeducation 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.
Receives: Behavioral: Psychoeducation control
Experimental web-based interventionExperimentalCPs 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.
Receives: Behavioral: Web-based intervention for concerned partners

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CP Depression Symptoms Questionnaire

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

    Measured: 1 month post-intervention.

  2. CP Anxiety Symptoms Questionnaire

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

    Measured: 1 month post-intervention.

  3. CP Anger expression questionnaire

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

    Measured: 1 month post-intervention.

  4. 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.

    Measured: 1 month post-intervention.

  5. CP Partner Social Support Questionnaire

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

    Measured: 1 month post-intervention.

  6. CP-DP Relationship Functioning Questionnaire

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

    Measured: 1 month post-intervention.

  7. DP AUDIT Questionnaire

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

    Measured: 1 month post-intervention.

  8. 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.

    Measured: 1 month post-intervention.

  9. 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.

    Measured: 1 month post-intervention.

  10. 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.

    Measured: 1 month post-intervention.

  11. 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.

    Measured: 1 month post-intervention.

Secondary outcomes (4)

  1. CP-DP Communication Questionnaire

    Family Environment via the Brief Family Relationship Scale. Fok, C. C., Allen, J., Henry, D., \& People Awakening Team (2014). The brief family relationship scale: a brief measure of the relationship dimension in family functioning. Assessment, 21(1), 67-72. https://doi.org/10.1177/1073191111425856. Cohesion, expressiveness, and conflict subscales. Items are averaged. For each subscale, greater scores reflect greater cohesion, expressiveness, and constructive ways of handling conflict.

    Measured: 1 month post-intervention.

  2. CP-DP Perceived Partner Responsiveness Questionnaire

    Measures perceived partner responsiveness. Scores range from 1-5. Greater scores mean greater responsiveness perceived about the partner.

    Source articles:

    Laurenceau, J. P., Barrett, L. F., \& Pietromonaco, P. R. (1998). Intimacy as an interpersonal process: The importance of self-disclosure, partner disclosure, and perceived partner responsiveness in interpersonal exchanges. Journal of Personality and Social Psychology, 74(5), 1238-1251. https://doi.org/10.1037//0022-3514.74.5.1238 O'Neill, A.S., Mohr, C.D., Bodner, T., \& Hammer, L. (2020). Perceived Partner Responsiveness, Sleep and Pain: A Dyadic Study of Military-Connected Couples. Health Psychology, 39(12), 1089-1099. https://doi.org/10.1037/hea0001035

    Measured: 1 month post-intervention.

  3. CP Communication about Drinking Questionnaire

    We have created a measure adapted from the Spouse Behavior Questionnaire (Love et al., 1991) and the Partner Management Strategies Questionnaire (Rodriguez et al., 2013) that will assess different behaviors CPs use to attempt to change their partner's drinking. Subscales include punishing drinking, rewarding sobriety, withdrawing, and supporting drinking. Items are averaged. Higher scores mean greater endorsement of these subscales.

    Measured: 1 month post-intervention.

  4. CP-DP Communication: Number of conflicts

    We will ask participants the number of disagreements they have had with their partner. Higher numbers denote more disagreements.

    Measured: 1 month post-intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2024
  2. Study start29 Sep 2026 (estimated)
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06670794
Sponsor's protocol ID
IRB202401222
Other IDs
1R34AA030182-01A1
Status last verified
Jul 2026
First submitted
30 Oct 2024
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data will be deidentified, but shared data will be at the individual level.

Questions about this trial

What is this clinical trial studying?

A study testing Web-based intervention for concerned partners in people with Experimental and Control Condition, run by University of Florida.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lindsey Rodriguez, Ph.D. (650-613-3484, lmrodriguez@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CP Depression Symptoms Questionnaire (time frame: 1 month post-intervention.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06670794.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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