- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06670794
Using Ecological Momentary Data to Inform a Web Intervention for Romantic Partners Concerned About Their Loved Ones' Drinking
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lindsey Rodriguez, Ph.D.
- Phone Number: 650-613-3484
- Email: lmrodriguez@ufl.edu
Study Contact Backup
- Name: Karen Osilla, Ph.D.
- Email: kosilla@stanford.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Psychoeducation control
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.
|
This is a psychoeducation control condition.
|
|
Experimental: Experimental web-based intervention
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CP Depression Symptoms Questionnaire
Time Frame: 1 month post-intervention.
|
Patient Health Questionnaire.
8 items.
Scores range from 0-32.
Higher scores indicate more depressive symptoms.
|
1 month post-intervention.
|
|
CP Anxiety Symptoms Questionnaire
Time Frame: 1 month post-intervention.
|
Generalized Anxiety Disorder scale.
7 items.
Higher scores indicate more anxiety symptoms.
|
1 month post-intervention.
|
|
CP Anger expression questionnaire
Time Frame: 1 month post-intervention.
|
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
Time Frame: 1 month post-intervention.
|
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
Time Frame: 1 month post-intervention.
|
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
Time Frame: 1 month post-intervention.
|
Quality of Marriage Index (Norton, 1983).
Higher scores indicate greater relationship satisfaction.
|
1 month post-intervention.
|
|
DP AUDIT Questionnaire
Time Frame: 1 month post-intervention.
|
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
Time Frame: 1 month post-intervention.
|
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
Time Frame: 1 month post-intervention.
|
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
Time Frame: 1 month post-intervention.
|
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
Time Frame: 1 month post-intervention.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CP-DP Communication Questionnaire
Time Frame: 1 month post-intervention.
|
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.
|
1 month post-intervention.
|
|
CP-DP Perceived Partner Responsiveness Questionnaire
Time Frame: 1 month post-intervention.
|
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 |
1 month post-intervention.
|
|
CP Communication about Drinking Questionnaire
Time Frame: 1 month post-intervention.
|
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.
|
1 month post-intervention.
|
|
CP-DP Communication: Number of conflicts
Time Frame: 1 month post-intervention.
|
We will ask participants the number of disagreements they have had with their partner.
Higher numbers denote more disagreements.
|
1 month post-intervention.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lindsey Rodriguez, Ph.D., University of Florida
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB202401222
- 1R34AA030182-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Experimental
-
University of British ColumbiaOttawa Hospital Research Institute; Government of AlbertaCompleted
-
Philipps University Marburg Medical CenterCompletedControl Group | Experimental Group 1 (Video Personal Expert) | Experimental Group 2 (Video Factual Expert)Germany
-
University of California, San DiegoUniversity of Central Florida; Pacific Institute for Research and Evaluation; Chestnut Health SystemsCompletedExperimental | ControlUnited States
-
Peking UniversityPeking University International Hospital; Hebei Medical University Fourth HospitalUnknown
-
University of OttawaRecruiting
-
Universiti Putra MalaysiaEnrolling by invitationExperimental MyastheniaChina
-
Universiti Putra MalaysiaCompletedExperimental MyastheniaChina
-
Anwita BiosciencesShanghai Junshi Bioscience Co., Ltd.RecruitingLymphoma | Solid Tumor, Adult | Neoplasm Malignant | Neoplasm, ExperimentalTaiwan
-
University of Maryland, College ParkEnrolling by invitationExperimental | Waitlist ControlUnited States
-
Florida State UniversityCompletedExperimental | Placebo ContolUnited States
Clinical Trials on Psychoeducation control
-
TAO AnCompletedFrailty | Well-Being, PsychologicalHong Kong
-
TAO AnRecruitingFrailty | Well-Being, PsychologicalHong Kong
-
West Virginia UniversityCompletedBreast Feeding | Maternal Behavior | Infant Behavior | Lactation Puerperal IncreasedUnited States
-
St. Joseph's Healthcare HamiltonNot yet recruitingCannabis Use | Eating DisordersCanada
-
Mayo ClinicCompleted
-
Basque Health ServiceCarlos III Health InstituteCompleted
-
University of ReginaCompletedDepression, AnxietyCanada
-
Toronto Metropolitan UniversityRecruitingCaregiver Burden | Caregiver StressCanada
-
I.R.C.C.S. Fondazione Santa LuciaRecruiting
-
Technical University of MunichCompletedSchizophrenia | Schizoaffective DisorderGermany