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

A Randomized Controlled Group Intervention Trial for Siblings and Parents of Children With Chronic Illness (SIBS-RCT)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Siblings of Children With Chronic Illness
• Intervention / Treatment: Behavioral: SIBS intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 288
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Norge
    • Oslo, Norge, Norway, 0317
      • University of Oslo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: SIBS intervention; SIBS is a manual-based group intervention for siblings and parents of children with chronic illness
No Intervention: Waitlist; Waitlist is 12 week of no intervention/usual care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: Sykehuset Innlandet HF; Lovisenberg Diakonale Hospital

Publications and helpful links

General Publications

• Fjermestad KW, Silverman WK, Vatne TM. Group intervention for siblings and parents of children with chronic disorders (SIBS-RCT): study protocol for a randomized controlled trial. Trials. 2020 Oct 14;21(1):851. doi: 10.1186/s13063-020-04781-6.

Helpful Links

• Project website

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2032

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 2018/2461

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The scientific advisory board for this trial involves researchers from multiple sites, and de-identified data will be shared although details are not set.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No