Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2021-05-10
2023-12-06
Brief Summary
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The study will be conducted in close collaboration with schools and local health care providers. The CICI Study focuses on the child's and parents' individually identified target outcome areas and rehabilitation goals. The intervention aims to enhance everyday functioning in the home and school environment by attaining rehabilitation goals in areas noted as challenging by the participants. The efficacy of the CICI-intervention will be measured in terms of goal attainment, burden of brain injury related symptoms, parenting self-efficacy, unmet health care needs, as well as several aspects of child, parent and family functioning.
Detailed Description
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Eighty families will be included in the study: 40 in the intervention group and 40 in the control group. The children will have a clinical ABI diagnosis, verified injury related intracranial abnormalities, and be at least one year post injury at inclusion. The children and/or their families must report enduring cognitive, emotional, social or physical challenges related to the brain injury. The intervention will be conducted in collaboration with the children's families, schools and their local health care providers. It consists of individualized goal-oriented strategies adapted to the home- and school-setting. Goal attainment scaling will be applied. In addition, psychoeducation will be provided to the family and school/local care providers on topics related to the child's injury. A parent group session will be held for discussions and knowledge transfer concerning family challenges after pABI, such as communication skills and parenting. The intervention will include 7 individualized meetings with the family (7 sessions whereof most will be videoconferences, but with the possibility of 1-2 of the sessions being home visits), one parent group seminar and 4 sessions with school and local health care providers during a period of 4-5 months.
Assessments will be conducted at baseline (T1), at the end of the intervention (T2, 4-5 months after inclusion) and one year after inclusion (T3). Baseline assessment includes a brief neuropsychological assessment of the children in addition to the outcome measures at T2 and T3. Outcome assessors will ble blinded to group allocation. Primary outcomes are change in parent-reported brain injury symptoms of the children and change in parenting self-efficacy. Secondary outcomes include change in child-rated severity of brain injury symptoms, change in unmet healthcare needs of the family, change in children's executive functioning in the home and school environment as assessed by parents, children and teachers, change in children's quality of life assessed by parents and children, change in family functioning, change in caregiver emotional symptoms, an evaluation of the intervention completed by parents, children and teachers in the intervention group, change in the perceived severity of the individually defined target outcome areas completed by children and parents, and change in goal attainment scaling in the intervention group.
The findings of this study will contribute to enhanced clinical expertise within pABI-rehabilitation on a specialist health care level, and will also be relevant for a wide array of health care professionals in the community as well as the educational system and parents of children with ABI.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Family-centered in home rehabilitation
Seven individualized meetings with the family (7 sessions whereof most will be videoconferences, with the possibility of 1-2 of the sessions being home visits), one parent group seminar and 4 meetings (three videoconferences and one phone call) with school and local care providers during a period of 4-5 months.
Based on target outcomes areas noted by children and parents, individual goals will be established (2-5 per family). Strategies to meet goals will be established for each goal, and goal attainment scaling will be used to quantify goal attainment.
Family centered in-home rehabilitation
Goal-oriented individualized intervention targeting brain injury related areas noted as challenging by the child and family
Control group
Usual health care and rehabilitation services provided in the municipality, including school.
Control
Usual follow-up in the municipality
Interventions
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Family centered in-home rehabilitation
Goal-oriented individualized intervention targeting brain injury related areas noted as challenging by the child and family
Control
Usual follow-up in the municipality
Eligibility Criteria
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Inclusion Criteria
* The above-mentioned children, and/or their parents, report ABI-related cognitive, emotional, or behavioral problems that affect participation in activities with family, friends, school and/or community.
* The children attend school regularly, with or without injury-related adaptations.
* The family is able to actively participate in a goal-oriented approach, this includes speaking sufficiently Norwegian. An exception can be made for parents who speak English but are able to understand and read Norwegian.
Exclusion Criteria
* Patients with brain tumors in active treatment or at great risk of relapse (i.e., unstable condition).
* Patients with severe psychiatric illness or children with injuries so severe that they are in institutionalized care most of the time.
* Parental severe psychiatric illness, drug abuse or indications of a history of or risk of domestic violence.
6 Years
16 Years
ALL
No
Sponsors
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The Research Council of Norway
OTHER
Oslo University Hospital
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Monash University
OTHER
The Hospital of Vestfold
OTHER
Sunnaas Rehabilitation Hospital
OTHER
Responsible Party
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Principal Investigators
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Marianne Løvstad, PhD
Role: PRINCIPAL_INVESTIGATOR
Sunnaas Rehabilitation Hospital and University of Oslo
Locations
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Sunnaas Rehabilitaion Hospital
Nesoddtangen, Akershus, Norway
Countries
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References
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Holthe IL, Rohrer-Baumgartner NM, Svendsen EJ, Roe C, Borgen IMH, Hauger SL, Ponsford JL, Egeland J, Wade S, Lovstad M. SMART-goal domains and goal attainment in an individualized, goal-oriented intervention for children with acquired brain injury and their families. Neuropsychol Rehabil. 2025 Jul;35(6):1229-1253. doi: 10.1080/09602011.2024.2402095. Epub 2024 Sep 16.
Rohrer-Baumgartner N, Holthe IL, Svendsen EJ, Roe C, Egeland J, Borgen IMH, Hauger SL, Forslund MV, Brunborg C, Ora HP, Dahl HM, Bragstad LK, Killi EM, Sandhaug M, Kleffelgard I, Strand-Saugnes AP, Dahl-Hilstad I, Ponsford J, Winter L, Wade S, Lovstad M. Rehabilitation for children with chronic acquired brain injury in the Child in Context Intervention (CICI) study: study protocol for a randomized controlled trial. Trials. 2022 Feb 22;23(1):169. doi: 10.1186/s13063-022-06048-8.
Other Identifiers
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SunnaasRH_CICI226059
Identifier Type: -
Identifier Source: org_study_id