Clinical trial NCT04056884: SIBS-Intervention for Siblings and Parents of Children With Chronic Illness
Official title: A Randomized Controlled Group Intervention Trial for Siblings and Parents of Children With Chronic Illness (SIBS-RCT)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Siblings of Children With Chronic Illness
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Sykehuset Innlandet HF
name: Lovisenberg Diakonale Hospital
First posted: 2019-08-14
Enrollment: 288
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants are randomized to intervention or 12-week waitlist. All participants who are randomized to waitlist will receive the intervention after waitlist.
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Strengths and difficulties questionnaire (SDQ)
timeFrame: Pre to 12-months follow-up
Secondary outcomes:
measure: Parent Child Communication Scale (PCCS)
timeFrame: Pre to 12-months follow-up
measure: KINDL Fragebogen (KINDL)
timeFrame: Pre to 12-months follow-up
measure: Sibling Knowledge Interview (SKI)
timeFrame: Pre to 12-months follow-up
measure: Negative Adjustment Scale (NAS)
timeFrame: Pre to 12-months follow-up
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
state: Norge
Study officials:
References:
citation: 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.