Siblings of Children With Chronic IllnessSIBS-RCTNCT04056884
SIBS-Intervention for Siblings and Parents of Children With Chronic Illness
A study testing SIBS intervention in people with Siblings of Children With Chronic Illness, run by University of Oslo at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Siblings of Children With Chronic Illness
- What is being tested?
- SIBS intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2019to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Being enrolled as primary patients in specialist health services;
- Chronic illness diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- SIBS intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIBS interventionBehavioural
SIBS is a manual-based group intervention for siblings and parents of children with chronic illness
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SIBS intervention |
| Waitlist | No intervention | Waitlist is 12 week of no intervention/usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strengths and difficulties questionnaire (SDQ)
Sibling mental health, reported by siblings, parents, and main teacher
Measured: Pre to 12-months follow-up
Secondary outcomes (4)
Parent Child Communication Scale (PCCS)
Family communication, reported by siblings and parents
Measured: Pre to 12-months follow-up
KINDL Fragebogen (KINDL)
Sibling quality of life, rated by siblings and parents
Measured: Pre to 12-months follow-up
Sibling Knowledge Interview (SKI)
Sibling disorder knowledge based on brief interview
Measured: Pre to 12-months follow-up
Negative Adjustment Scale (NAS)
Sibling adaption, reported by siblings
Measured: Pre to 12-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start1 Sep 2019
- Primary completion30 Sep 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Siblings of Children With Chronic IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Sykehuset Innlandet HF, Lovisenberg Diakonale Hospital
- Responsible party
- Principal investigator, Krister W Fjermestad, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056884
- Sponsor's protocol ID
- 2018/2461
- Acronym
- SIBS-RCT
- Status last verified
- Apr 2024
- First submitted
- 12 Aug 2019
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The scientific advisory board for this trial involves researchers from multiple sites, and de-identified data will be shared although details are not set.
Publications
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.
PubMed 41121407Kirchhofer 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.
PubMed 40146207Fjermestad 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.
PubMed 33054825
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Group Intervention Trial for Siblings and Parents of Children With Chronic Illness (SIBS-RCT)
- ClinicalTrials.gov ID
- NCT04056884
- Acronym / sponsor ID
- SIBS-RCT / 2018/2461
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Sykehuset Innlandet HF, Lovisenberg Diakonale Hospital
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 14 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized to intervention or 12-week waitlist. All participants who are randomized to waitlist will receive the intervention after waitlist.
| Arm | Type | Receives |
|---|---|---|
| SIBS intervention | Active comparator | Behavioral: SIBS interventionSIBS 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 | No intervention | –Waitlist is 12 week of no intervention/usual care |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Being enrolled as primary patients in specialist health services;
- Chronic illness diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIBS interventionSIBS is a manual-based group intervention for siblings and parents of children with chronic illness | Behavioural | SIBS intervention |
Primary outcome
Strengths and difficulties questionnaire (SDQ)
Time frame: Pre to 12-months follow-up
Sibling mental health, reported by siblings, parents, and main teacher
4 secondary outcomes
Parent Child Communication Scale (PCCS)
Time frame: Pre to 12-months follow-up
KINDL Fragebogen (KINDL)
Time frame: Pre to 12-months follow-up
Sibling Knowledge Interview (SKI)
Time frame: Pre to 12-months follow-up
Negative Adjustment Scale (NAS)
Time frame: Pre to 12-months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Derived from this study: PubMed 41121407Schumann 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.
- Derived from this study: PubMed 40146207Kirchhofer 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.
- Derived from this study: PubMed 33054825Fjermestad 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.
- Project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. The scientific advisory board for this trial involves researchers from multiple sites, and de-identified data will be shared although details are not set.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIBS intervention in people with Siblings of Children With Chronic Illness, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strengths and difficulties questionnaire (SDQ) (time frame: Pre to 12-months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04056884, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.