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

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ClinicalTrials.gov Identifier: NCT04056884
Recruitment Status : Enrolling by invitation
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
Sykehuset Innlandet HF
Lovisenberg Diakonale Hospital
Information provided by (Responsible Party):
Krister W Fjermestad, University of Oslo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Siblings of Children With Chronic Illness Behavioral: SIBS intervention Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
Masking Description: N/A, not possible
Primary Purpose: Prevention
Official Title: A Randomized Controlled Group Intervention Trial for Siblings and Parents of Children With Chronic Illness (SIBS-RCT)
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2032

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 Behavioral: SIBS intervention
SIBS is a manual-based group intervention for siblings and parents of children with chronic illness
No Intervention: Waitlist
Waitlist is 12 week of no intervention/usual care


Outcome Measures
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Primary Outcome Measures :
  1. Strengths and difficulties questionnaire (SDQ) [ Time Frame: Pre to 12-months follow-up ]
    Sibling mental health, reported by siblings, parents, and main teacher


Secondary Outcome Measures :
  1. Parent Child Communication Scale (PCCS) [ Time Frame: Pre to 12-months follow-up ]
    Family communication, reported by siblings and parents

  2. KINDL Fragebogen (KINDL) [ Time Frame: Pre to 12-months follow-up ]
    Sibling quality of life, rated by siblings and parents

  3. Sibling Knowledge Interview (SKI) [ Time Frame: Pre to 12-months follow-up ]
    Sibling disorder knowledge based on brief interview

  4. Negative Adjustment Scale (NAS) [ Time Frame: Pre to 12-months follow-up ]
    Sibling adaption, reported by siblings


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056884


Locations
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Norway
University of Oslo
Oslo, Norge, Norway, 0317
Sponsors and Collaborators
University of Oslo
Sykehuset Innlandet HF
Lovisenberg Diakonale Hospital
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Krister W Fjermestad, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT04056884    
Other Study ID Numbers: 2018/2461
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes