Study protocol for a sequential multiple assignment randomized trial to reduce risky drinking among service members and their partners

Karen Chan Osilla; Kristie L Gore; Eric R Pedersen; Justin F Hummer; Maria DeYoreo; Jennifer K Manuel; James R McKay; Jane P Kim; Katherine Nameth

doi:10.1016/j.cct.2023.107324

Study protocol for a sequential multiple assignment randomized trial to reduce risky drinking among service members and their partners

Contemp Clin Trials. 2023 Oct:133:107324. doi: 10.1016/j.cct.2023.107324. Epub 2023 Aug 29.

Authors

Karen Chan Osilla¹, Kristie L Gore², Eric R Pedersen³, Justin F Hummer⁴, Maria DeYoreo⁴, Jennifer K Manuel⁵, James R McKay⁶, Jane P Kim⁷, Katherine Nameth⁷

Affiliations

¹ Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences, 1070 Arastradero Road, Palo Alto, CA 94304, USA. Electronic address: kosilla@stanford.edu.
² RAND Corporation, 1200 S Hayes St, Arlington, VA 22202, USA.
³ University of Southern California Keck School of Medicine, Department of Psychiatry and Behavioral Sciences, 2250 Alcazar Street, Suite 2200, Los Angeles, CA 90033, USA.
⁴ RAND Corporation, 1776 Main Street, PO Box 2136, Santa Monica, CA 90407-2138, USA.
⁵ San Francisco VA Health Care System, 4150 Clement St, San Francisco, CA 94121, USA; University of California San Francisco, Department of Psychiatry and Behavioral Sciences, 401 Parnassus Ave, San Francisco, CA 94143, USA.
⁶ Center for Studies of Addiction, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Crescenz VAMC, Philadelphia, PA, USA.
⁷ Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences, 1070 Arastradero Road, Palo Alto, CA 94304, USA.

PMID: 37652360
PMCID: PMC10591961 (available on 2024-10-01)
DOI: 10.1016/j.cct.2023.107324

Abstract

Background: Military spouses and partners in relationships with a heavy drinking service member report high levels of mental health concerns and consequences, which are compounded when both partners drink heavily. Military spouses and partners -termed "concerned partners" (CPs)-may be an important gateway for motivating service members (SMs) to seek care. However, CPs may first need to reduce their own drinking and improve their communication to effectively support and encourage changes for their service member partner. Partners Connect is a web-based intervention aimed at improving communication and relationship quality and increasing SM help-seeking.

Methods: The current study design is a two-stage Sequential Multiple Assignment Randomized Trial (SMART) to develop an adaptive CP intervention to decrease CP drinking and increase SM help-seeking. CPs aged 18 and older (n = 408) will be recruited via social media and followed for six months. In stage one, we will randomize CPs to either a 4-session web-based intervention (Partners Connect) or to receive communication resources from the Gottman Institute website. The goal is to have CPs invite their SM to complete an online personalized normative feedback (PNF) session. If their SM completes the PNF at stage one, CPs will be considered "responders," if the SM does not complete, CPs who are "non-responders" will be re-randomized during stage two to receive either (1) a CRAFT workbook or (2) phone-based CRAFT if in Partners Connect; or (1) Partners Connect or (2) a CRAFT workbook if in Gottman.

Discussion: By first intervening with the service member's CP, we aim to better equip them to engage their service member partner in treatment services. In doing so, we develop a model that increases treatment accessibility and appeal among a group that may not otherwise seek care.

Clinicaltrials: gov Identifier: NCT05619185.

Keywords: Alcohol use disorder; CRAFT; Military; Unilateral family therapy; Web-based intervention.

Associated data

ClinicalTrials.gov/NCT05619185

Grants and funding

R01 AA030258/AA/NIAAA NIH HHS/United States