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

NCT ID: NCT04056884

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2024-09-30

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.

Conditions

Siblings of Children With Chronic Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

SIBS intervention

Intervention Type: BEHAVIORAL

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

Waitlist

Waitlist is 12 week of no intervention/usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SIBS intervention

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sykehuset Innlandet HF

OTHER

Sponsor Role: collaborator

Lovisenberg Diakonale Hospital

OTHER

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: lead

Responsible Party

Krister W Fjermestad

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Oslo

Oslo, Norge, Norway

Countries

Norway

References

Schumann A, Vatne TM, Dalton L, Rapa E, Fjermestad KW. "It's like a car that doesn't like gasoline" - a qualitative study of siblings' understanding of anorexia nervosa in childhood: perspectives from siblings and parents. J Eat Disord. 2025 Oct 21;13(1):231. doi: 10.1186/s40337-025-01263-5.

Reference Type: DERIVED

PMID: 41121407 (View on PubMed)

Kirchhofer SM, Fredriksen T, Orm S, Botta M, Zahl E, Cogo-Moreira H, Prentice CM, Vatne TM, Haukeland YB, Silverman WK, Fjermestad KW. Effectiveness of a group intervention to improve mental health in siblings of children with chronic disorders: a cluster randomized controlled trial. J Pediatr Psychol. 2025 Jun 1;50(6):443-453. doi: 10.1093/jpepsy/jsaf021.

Reference Type: DERIVED

PMID: 40146207 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33054825 (View on PubMed)

Related Links

http://www.sibs.no

Project website

Other Identifiers

2018/2461

Identifier Type: -

Identifier Source: org_study_id