Citation

Dworkin ER, Ruzek JI, Cordova MJ, Fitzpatrick S, Merchant L, Stewart T, Santos JP, Mohr J, Bedard-Gilligan M. Contemp. Clin. Trials 2022; ePub(ePub): ePub.

Copyright

(Copyright © 2022, Elsevier Publishing)

DOI

10.1016/j.cct.2022.106848

PMID

35817294

Abstract

INTRODUCTION: Sexual assault is a common form of trauma that is associated with elevated risk for negative psychosocial 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 inadvertently 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 randomized controlled trial is warranted.

Language: en

Keywords

*Acute stress; *Dyadic intervention; *Prevention; *Relationships; *Social support