Supporter-focused early intervention for recent sexual assault survivors: Study protocol for a pilot randomized clinical trial

Introduction: Sexual assault is a common form of trauma that is associated with elevated risk for negative psy-chosocial outcomes. Although survivors' social relationships could serve as a major protective factor against negative outcomes, survivors' supporters often lack knowledge regarding effective responses and may inad-vertently respond in ways that are detrimental to healing. Communication and Recovery Enhancement (CARE) is a 2-session early intervention for survivors of a past-10-week sexual assault and their supporters that aims to improve supporters' ability to respond effectively.Objective: In this paper, we present a study protocol for a pilot randomized clinical trial of CARE (NCT05345405). The goal of this pilot trial is to understand the feasibility, acceptability, and preliminary efficacy of two versions of CARE: a version in which survivors and supporters attend sessions together (dyadic version) and a version in which supporters attend sessions alone (supporter-only version).Methods: Survivors aged 14+ with elevated posttraumatic stress will enroll with a supporter of their choosing. Dyads will be randomized to dyadic CARE, supporter-only CARE, or waitlist control, and will complete self -report assessments at baseline, post-session-1, and follow-ups (1, 2, and 3 months post-baseline). We will use descriptive statistics, effect sizes, and exploratory statistical tests to characterize the acceptability of both CARE versions, impact on knowledge change from baseline to 1 month, impact on disclosure experiences at 1 month, and impact on functional outcomes at 3 months. Discussion: Results will be used to inform future changes to CARE and determine whether a fully-powered ran-domized controlled trial is warranted.