NCT04056884

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

September 16, 2025

Status Verified

April 1, 2024

Enrollment Period

4.1 years

First QC Date

August 12, 2019

Last Update Submit

September 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Strengths and difficulties questionnaire (SDQ)

    Sibling mental health, reported by siblings, parents, and main teacher

    Pre to 12-months follow-up

Secondary Outcomes (4)

  • Parent Child Communication Scale (PCCS)

    Pre to 12-months follow-up

  • KINDL Fragebogen (KINDL)

    Pre to 12-months follow-up

  • Sibling Knowledge Interview (SKI)

    Pre to 12-months follow-up

  • Negative Adjustment Scale (NAS)

    Pre to 12-months follow-up

Study Arms (2)

SIBS intervention

ACTIVE COMPARATOR

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

Waitlist

NO INTERVENTION

Waitlist is 12 week of no intervention/usual care

Interventions

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

SIBS intervention

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • One parent able to attend the intervention.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, Norge, 0317, Norway

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
N/A, not possible
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Participants are randomized to intervention or 12-week waitlist. All participants who are randomized to waitlist will receive the intervention after waitlist.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 14, 2019

Study Start

September 1, 2019

Primary Completion

September 30, 2023

Study Completion

September 30, 2024

Last Updated

September 16, 2025

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

The scientific advisory board for this trial involves researchers from multiple sites, and de-identified data will be shared although details are not set.

Locations