The effects of a transdiagnostic ecological momentary intervention for improving self-esteem (SELFIE) in youth exposed to childhood adversity: data analysis plan for a multi-center randomized controlled trial

Autor: Reininghaus, Ulrich, Daemen, Maud, Schick, Anita, Postma, Mary, Volbragt, Nele, Lindauer, Ramon, van der Meulen, Iris, Nieman, Dorien, Delespaul, Philippe, Breedvelt, Josefien, van der Gaag, Mark, Viechtbauer, Wolfgang, van den Berg, David, Bockting, Claudi, van Amelsvoort, Therese
Rok vydání: 2022
Předmět:
DOI: 10.17605/osf.io/8e4bc
Popis: For a detailed description of the study, please see our published study protocol (1). This preregistration includes the Statistical Analysis Plan (see sections 21-25) for this multicenter randomized controlled trial, which must be read and considered in conjunction with the published study protocol (1). Targeting low self-esteem in youth exposed to childhood adversity is a promising strategy for preventing adult mental disorder, but psychological help remains difficult to access and accept for youth, calling for novel, youth-friendly approaches. Mobile Health (mHealth) and, most prominently, ecological momentary interventions (EMIs) provide a unique opportunity to deliver youth-friendly, personalized, real-time, guided self-help interventions. The aim of the SELFIE trial is to investigate the efficacy of a novel, accessible, transdiagnostic ecological momentary intervention for improving self-esteem (‘SELFIE’) in youth aged 12-26 years with prior exposure to childhood adversity. (Preliminary remarks) Sections of this pre-registration are taken from the SELFIE study protocol (please refer to Daemen, Postma (1) for further details). The present preregistration focuses on the main hypotheses on primary and secondary outcomes at 6-month follow-up that will be tested and reported in the first manuscript. In addition, we will report the statistical analysis plan for hypotheses relating to outcomes at 18-month and 24-month follow-up, which will be reported in a subsequent manuscript. The statistical analysis plan for hypotheses relating to hypotheses on cost effectiveness and cost utility will be described in a subsequent preregistration report.
Databáze: OpenAIRE