Group intervention for siblings and parents of children with chronic disorders (SIBS-RCT): study protocol for a randomized controlled trial

Fjermestad et al. Trials (2020) 21:851 https://doi.org/10.1186/s13063-020-04781-6 STUDY PROTOCOL Open Access Group intervention for siblings and parents of children with chronic disorders (SIBSRCT): study protocol for a randomized controlled trial Krister W. Fjermestad1* , Wendy K. Silverman2,3 and Torun M. Vatne1,4 Abstract Background: Siblings and parents of children with neurodevelopmental disorders are at risk of mental health problems and poorer family communication. Some group interventions for siblings exist, but few have clearly described parent components and none are considered evidence-based. Methods: We are conducting a randomized controlled trial comparing a five-session manual-based group intervention for siblings (aged 8 to 16 years) and parents of children with neurodevelopmental disorders to a 12week waitlist, called SIBS-RCT. The intervention comprises three separate sibling and parent group sessions and two joint sessions in which each sibling talks to their parent alone. The intervention aims at improving parent-child communication and covers themes such as siblings’ understanding of the neurodevelopmental disorder, siblings’ emotions, and perceived family challenges. Participants are recruited through municipal and specialist health centers across Norway. The primary outcome is sibling mental health. Quality of life and family communication are secondary outcomes. Participants are block-randomized to the intervention or 12-week waitlist in groups of six. Measures are collected electronically at pre- and post-intervention/waitlist, as well as 3, 6, and 12 months postintervention. The main effect to be examined is the difference between the intervention and waitlist at 12 weeks post. All outcomes will also be examined using growth curve analyses. We plan to include 288 siblings and their parents by the end of 2022. Discussion: SIBS-RCT represents a major contribution to the research and practice field towards establishing an evidence-based intervention for siblings. In the event that intervention and waitlist are no different, the impact of SIBS-RCT is still substantial in that we will aim to identify participant subgroups that show positive response and effective components of the SIBS manual by examining group leader adherence as an outcome predictor. This will allow us to continue to re-engineer the SIBS manual iteratively to improve outcomes, and avoid the promotion of a less-than-optimal intervention. Trial registration: ClinicalTrials.gov NCT04056884. Registered in August 2019 Keywords: Randomized controlled trial, Study protocol, Group intervention, Siblings, Young carers, Neurodevelopmental disorders, Family communication, Mental health * Correspondence: 1 Department of Psychology, University of Oslo, New Haven, Norway Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Fjermestad et al. Trials (2020) 21:851 Administrative information The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standardprotocol-items-for-clinical-trials/). Title {1} Group intervention for siblings and parents of children with chronic disorders (SIBS-RCT): Study protocol for a randomized controlled trial Trial registration {2a and 2b}. ClinicalTrials.gov. Project identifier: NCT04056884 Protocol version {3} Version 1; September 2019 Funding {4} Internal funding by the main project organizers: Department of Psychology, University of Oslo, Norway: and Frambu Resource Centre for rare disorders, Norway. In-kind contributions from intervention sites (i.e., no major external funding sponsor). Author details {5a} Department of Psychology, University of Oslo, Norway, and Frambu Resource Centre for rare disorders, Norway. Name and contact information for the trial sponsor {5b} Department of Psychology, University of Oslo, Po Box 1094 Blindern, 0317 Oslo, Norway. joakim.dyrnes@psykologi. uio.no Frambu Resource Centre for rare disorders, Sandbakkveien 18, 1404 Siggerud, Norway. National Advisory Unit for Rare Disorders, Oslo University Hospital, Kirkeveien 166, Oslo, Norway. Role of sponsor {5c} The sponsors are jointly responsible for design, data collection, data analyses and results dissemination. All contributing intervention sites can use their own data, after agreement with the project management. Introduction Background and rationale {6a} Sibling relationships, our longest lasting bonds, represent a unique source of learning, support, and rivalry. Chronic illness in children involves risk for reduced well-being among siblings [1]. The mechanisms behind this risk are associated with (1) the chronic illness itself (e.g., behavior problems), (2) siblings’ lack of illness knowledge (e.g., misunderstandings), (3) poor parental mental health due to extra care responsibilities, and (4) poor family communication (e.g., less open and warm communication [2–4]). Previous sibling interventions have shown positive outcomes for siblings’ well-being (e.g., [5, 6]). However, systematic reviews have demonstrated that no intervention has an established evidence-base [7, 8]. Therefore, we plan to examine a group intervention for siblings and parents of children with chronic illness in a randomized Page 2 of 12 controlled trial (SIBS-RCT). SIBS-RCT is based on preliminary studies conducted by our consortium. First, we conducted a qualitative study of group sessions for 58 siblings of children with rare disorders. We found that siblings have limited disorder knowledge [4], conflictual emotions and passive coping strategies [9], and unique perspectives on their brothers and sisters with disorders [10]. Based on user feedback and these preliminary findings, we developed the SIBS intervention, a 5-session manual-based program with parallel sibling and parent groups. A unique feature of t (...truncated)