SIBS-Intervention for Siblings and Parents of Children With Chronic Illness (SIBS-RCT)
Primary Purpose
Siblings of Children With Chronic Illness
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
SIBS intervention
Sponsored by
About this trial
This is an interventional prevention trial for Siblings of Children With Chronic Illness
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Being enrolled as primary patients in specialist health services;
- Chronic illness diagnosis.
Sites / Locations
- University of Oslo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
SIBS intervention
Waitlist
Arm Description
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.
Waitlist is 12 week of no intervention/usual care
Outcomes
Primary Outcome Measures
Strengths and difficulties questionnaire (SDQ)
Sibling mental health, reported by siblings, parents, and main teacher
Secondary Outcome Measures
Parent Child Communication Scale (PCCS)
Family communication, reported by siblings and parents
KINDL Fragebogen (KINDL)
Sibling quality of life, rated by siblings and parents
Sibling Knowledge Interview (SKI)
Sibling disorder knowledge based on brief interview
Negative Adjustment Scale (NAS)
Sibling adaption, reported by siblings
Full Information
NCT ID
NCT04056884
First Posted
August 12, 2019
Last Updated
August 12, 2019
Sponsor
University of Oslo
Collaborators
Sykehuset Innlandet HF, Lovisenberg Diakonale Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04056884
Brief Title
SIBS-Intervention for Siblings and Parents of Children With Chronic Illness
Acronym
SIBS-RCT
Official Title
A Randomized Controlled Group Intervention Trial for Siblings and Parents of Children With Chronic Illness (SIBS-RCT)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2032 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
Sykehuset Innlandet HF, Lovisenberg Diakonale Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Siblings of Children With Chronic Illness
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants are randomized to intervention or 12-week waitlist. All participants who are randomized to waitlist will receive the intervention after waitlist.
Masking
None (Open Label)
Masking Description
N/A, not possible
Allocation
Randomized
Enrollment
288 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SIBS intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
Waitlist is 12 week of no intervention/usual care
Intervention Type
Behavioral
Intervention Name(s)
SIBS intervention
Intervention Description
SIBS is a manual-based group intervention for siblings and parents of children with chronic illness
Primary Outcome Measure Information:
Title
Strengths and difficulties questionnaire (SDQ)
Description
Sibling mental health, reported by siblings, parents, and main teacher
Time Frame
Pre to 12-months follow-up
Secondary Outcome Measure Information:
Title
Parent Child Communication Scale (PCCS)
Description
Family communication, reported by siblings and parents
Time Frame
Pre to 12-months follow-up
Title
KINDL Fragebogen (KINDL)
Description
Sibling quality of life, rated by siblings and parents
Time Frame
Pre to 12-months follow-up
Title
Sibling Knowledge Interview (SKI)
Description
Sibling disorder knowledge based on brief interview
Time Frame
Pre to 12-months follow-up
Title
Negative Adjustment Scale (NAS)
Description
Sibling adaption, reported by siblings
Time Frame
Pre to 12-months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Being enrolled as primary patients in specialist health services;
Chronic illness diagnosis.
Facility Information:
Facility Name
University of Oslo
City
Oslo
State/Province
Norge
ZIP/Postal Code
0317
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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.
Citations:
PubMed Identifier
33054825
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.
Results Reference
derived
Links:
URL
http://www.sibs.no
Description
Project website
Learn more about this trial
SIBS-Intervention for Siblings and Parents of Children With Chronic Illness
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