SIBS-Intervention for Siblings and Parents of Children With Chronic Illness

Overview

SIBS-RCT is a randomized controlled trial comparing the effect of a 5-session group intervention for siblings and parents of children with chronic illness to 12-week waitlist. Participants randomized to waitlist will receive the intervention after waitlist. The main outcome is sibling mental health, and secondary outcomes include family communication, sibling disorder knowledge, quality of life, and adaption. Outcomes will be examined at pre-, post, 3-, 6- and 12- month follow-up.

Full Title of Study: “A Randomized Controlled Group Intervention Trial for Siblings and Parents of Children With Chronic Illness (SIBS-RCT)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2022

Detailed Description

Siblings' wellbeing is at risk when one's brother or sister has a neurodevelopmental disorder. Neurodevelopmental disorders are enduring somatic and/or mental conditions affecting the central nervous system, such as autism, intellectual disability, and cerebral palsy. The mechanisms behind the wellbeing risk for siblings are linked to siblings' lack of disorder knowledge, poor parental mental health due to extra care responsibilities, and impaired family communication. No evidence-based interventions to improve sibling wellbeing exist. To address this gap, we propose examining a group intervention for siblings and parents of children with neurodevelopmental disorders in a randomized controlled trial (SIBS-RCT). SIBS-RCT compares a 5-session manual-based sibling-parent group intervention delivered over two weeks, to 3-month "treatment as usual" waitlist. The planned sample is 288 siblings and 288 parents. Recruitment and intervention will take place in specialist and municipal health services. Inclusion criteria are being the sibling (aged 8-16 years) of a child (aged 0-18 years) who is diagnosed with neurodevelopmental disorder and who receives specialist or municipal health services. Participants will be randomized in blocks of 6 to intervention or waitlist. The primary outcome is sibling mental health. Secondary outcomes include quality of life, disorder knowledge, and family communication. Predictor measures include biological stress levels, parent mental health, disorder impairment, and group leader adherence to the SIBS-manual. Measures will be electronically rated by siblings, parents, and teachers at pre-intervention, post-intervention, and 3, 6, and 12 months follow-up. Main effects of the intervention will be measured as the mean mental health change difference between intervention and waitlist from pre-intervention to 3-month follow-up. We will also apply growth curve models to examine trajectories of outcomes from pre-intervention to 12-month follow-up. Expected outcomes include improved sibling wellbeing, improved health services for siblings and families of children with neurodevelopmental disorders, and better integration between municipal and specialist services.

Interventions

  • Behavioral: SIBS intervention
    • SIBS is a manual-based group intervention for siblings and parents of children with chronic illness

Arms, Groups and Cohorts

  • Active Comparator: SIBS intervention
    • SIBS intervention is a 5-session group intervention for siblings and parents of children with chronic illness. Sessions 1-3 are delivered in one day, and sessions 4-5 are delivered in one day one week later.
  • No Intervention: Waitlist
    • Waitlist is 12 week of no intervention/usual care

Clinical Trial Outcome Measures

Primary Measures

  • Strengths and difficulties questionnaire (SDQ)
    • Time Frame: Pre to 12-months follow-up
    • Sibling mental health, reported by siblings, parents, and main teacher

Secondary Measures

  • Parent Child Communication Scale (PCCS)
    • Time Frame: Pre to 12-months follow-up
    • Family communication, reported by siblings and parents
  • KINDL Fragebogen (KINDL)
    • Time Frame: Pre to 12-months follow-up
    • Sibling quality of life, rated by siblings and parents
  • Sibling Knowledge Interview (SKI)
    • Time Frame: Pre to 12-months follow-up
    • Sibling disorder knowledge based on brief interview
  • Negative Adjustment Scale (NAS)
    • Time Frame: Pre to 12-months follow-up
    • Sibling adaption, reported by siblings

Participating in This Clinical Trial

Inclusion Criteria

1. Being the sibling of a child diagnosed with chronic illness who is aged 0 to 18 years and receives specialist and/or municipal health services. 2. One parent able to attend the intervention. Exclusion Criteria:

1. Being enrolled as primary patients in specialist health services; 2. Chronic illness diagnosis.

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Oslo
  • Collaborator
    • Sykehuset Innlandet HF
  • Provider of Information About this Clinical Study
    • Principal Investigator: Krister W Fjermestad, Professor – University of Oslo

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.