START NOW WebApp-promoting emotion regulation and resilience in residential youth care and correctional institutions: study protocol for a cluster randomized controlled trial

Abstract

Background: Adolescents and young adults in residential care and correctional institutions face various challenges, leading to negative life outcomes. Implementation barriers within these institutions, such as limited financial and spatial resources, pose significant hurdles to providing necessary support. Web-based approaches address these challenges by offering cost-effective, accessible solutions. This study aims to assess the efficacy of a newly developed web-based version of the existing evidence-based START NOW skills training in fostering emotion regulation and resilience among institutionalized adolescents and young adults. We present the study protocol (Version 5, August 2023) of the trial titled "Implementation of an e-version of the skills training START NOW for promoting emotion regulation and resilience in residential youth care and correctional institutions".

Methods: The study is a monocentric, prospective, confirmatory randomized controlled trial with 150 institutionalized adolescents and young adults with a need to improve resilience (predefined cut-offs). Participating institutions will be randomized to one of three conditions: (i) 9-week web-based group training guided by a facilitator, (ii) 9-week web-based self-help training, (iii) and treatment as usual. The primary endpoint is the change in psychological flexibility, assessed by the Avoidance and Fusion Questionnaire for Youth score, from baseline to follow-up 12 weeks post skills training. Secondary objectives encompass assessing pre-post changes in psychological flexibility and other psychological health-related outcome measures in participating adolescents, young adults, and caretakers from baseline, to post training, and to 12- and 24-week follow-ups.

Discussion: This study evaluates the efficacy of START NOW as web-based training for institutionalized adolescents and young adults, providing valuable insights into web-based interventions and aiming to optimize support levels. TRIAL REGISTRATION {2A AND 2B}: ClinicalTrials.gov NCT05313581. Registered on 6 April 2022.

Keywords: Adolescents; Emotion regulation; Intervention; Psychological flexibility; Randomized controlled trial; Residential youth care; Resilience; Young adults.