Rehabilitation for children with chronic acquired brain injury in the Child in Context Intervention (CICI) study: study protocol for a randomized controlled trial
Abstract Background Pediatric acquired brain injury (pABI) is associated with long-term cognitive, behavioral, social, and emotional problems, which may affect the quality of life, school, and family functioning. Yet, there is a lack of evidence-based community-centered rehabilitation programs for c...
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| Format: | Article |
| Language: | English |
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BMC
2022-02-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06048-8 |
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| author | Nina Rohrer-Baumgartner Ingvil Laberg Holthe Edel Jannecke Svendsen Cecilie Røe Jens Egeland Ida M. H. Borgen Solveig L. Hauger Marit V. Forslund Cathrine Brunborg Hege Prag Øra Hilde Margrete Dahl Line Kildal Bragstad Eli Marie Killi Maria Sandhaug Ingerid Kleffelgård Anine Pernille Strand-Saugnes Ingeborg Dahl-Hilstad Jennie Ponsford Laraine Winter Shari Wade Marianne Løvstad |
| author_facet | Nina Rohrer-Baumgartner Ingvil Laberg Holthe Edel Jannecke Svendsen Cecilie Røe Jens Egeland Ida M. H. Borgen Solveig L. Hauger Marit V. Forslund Cathrine Brunborg Hege Prag Øra Hilde Margrete Dahl Line Kildal Bragstad Eli Marie Killi Maria Sandhaug Ingerid Kleffelgård Anine Pernille Strand-Saugnes Ingeborg Dahl-Hilstad Jennie Ponsford Laraine Winter Shari Wade Marianne Løvstad |
| author_sort | Nina Rohrer-Baumgartner |
| collection | DOAJ |
| description | Abstract Background Pediatric acquired brain injury (pABI) is associated with long-term cognitive, behavioral, social, and emotional problems, which may affect the quality of life, school, and family functioning. Yet, there is a lack of evidence-based community-centered rehabilitation programs for chronic pABI and these children do not systematically receive comprehensive rehabilitation. The Child In Context Intervention (CICI) study is a pragmatic randomized controlled trial (RCT) for children with chronic pABI, which aims to evaluate the effectiveness of an individualized and goal-oriented intervention targeting everyday functioning of the child and family. Methods Children aged 6–16 years with MRI/CT-verified intracranial abnormalities will be included in the CICI study if they have persistent self- or parent-reported cognitive, emotional, and/or behavioral challenges 1 year or more after insult and attend school regularly. A total of 70 families will be randomized 1:1 to an intervention or a control group. The intervention consists of seven family sessions, one parent seminar, and four school sessions delivered over approximately 6 months. The parent seminar will be held in person, and the other sessions will mainly be video based. The children’s and families’ self-reported major challenges in everyday life will be targeted using SMART goals. Evidence-based strategies, when available, will be applied to achieve the goals, combined with psychoeducation. Goal attainment scaling (GAS) will be used to evaluate goal attainment. Data is collected at baseline and after approximately 6 and 9 months. External assessors are blinded to group allocation. Primary outcomes are parent-reported brain injury symptoms in children and parenting self-efficacy at 9 months of follow-up. Secondary outcomes include child-reported brain injury symptoms, quality of life, executive functioning in daily life, parent emotional symptoms, family functioning, and unmet family health care needs. A process evaluation will be conducted. Discussion The current study provides an innovative approach to rehabilitation for children in the chronic phase of ABI and their families. This complex intervention may contribute to the development of evidence-based, high-quality rehabilitation for a large patient group, which is underrepresented in clinical research. It may also improve collaboration between specialized rehabilitation facilities, schools, and local health care services. Inclusion for the trial started in April 2021. Trial registration ClinicalTrials.gov NCT04798859 . Registered on March 15, 2021 |
| first_indexed | 2024-12-20T17:38:32Z |
| format | Article |
| id | doaj.art-4456c6088452465fbb12cab587c8976a |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-20T17:38:32Z |
| publishDate | 2022-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-4456c6088452465fbb12cab587c8976a2022-12-21T19:31:10ZengBMCTrials1745-62152022-02-0123111410.1186/s13063-022-06048-8Rehabilitation for children with chronic acquired brain injury in the Child in Context Intervention (CICI) study: study protocol for a randomized controlled trialNina Rohrer-Baumgartner0Ingvil Laberg Holthe1Edel Jannecke Svendsen2Cecilie Røe3Jens Egeland4Ida M. H. Borgen5Solveig L. Hauger6Marit V. Forslund7Cathrine Brunborg8Hege Prag Øra9Hilde Margrete Dahl10Line Kildal Bragstad11Eli Marie Killi12Maria Sandhaug13Ingerid Kleffelgård14Anine Pernille Strand-Saugnes15Ingeborg Dahl-Hilstad16Jennie Ponsford17Laraine Winter18Shari Wade19Marianne Løvstad20Department of Research, Sunnaas Rehabilitation HospitalDepartment of Research, Sunnaas Rehabilitation HospitalDepartment of Research, Sunnaas Rehabilitation HospitalResearch Center for Habilitation and Rehabilitation Services and Models (CHARM), Institute of Health and Society, University of OsloInstitute of Psychology, University of OsloInstitute of Psychology, University of OsloDepartment of Research, Sunnaas Rehabilitation HospitalDepartment of Physical Medicine and Rehabilitation, Oslo University HospitalOslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University HospitalDepartment of Research, Sunnaas Rehabilitation HospitalDepartment of Clinical Neurosciences for Children, Oslo University HospitalResearch Center for Habilitation and Rehabilitation Services and Models (CHARM), Institute of Health and Society, University of OsloStatped: Norwegian Service for Special Needs EducationStatped: Norwegian Service for Special Needs EducationDepartment of Physical Medicine and Rehabilitation, Oslo University HospitalStatped: Norwegian Service for Special Needs EducationThe Norwegian Association for the Traumatically InjuredSchool of Psychological Sciences, Monash UniversityPhiladelphia Research and Education FoundationDivision of Physical Medicine and Rehabilitation, Cincinnati Children’s Hospital Medical CenterDepartment of Research, Sunnaas Rehabilitation HospitalAbstract Background Pediatric acquired brain injury (pABI) is associated with long-term cognitive, behavioral, social, and emotional problems, which may affect the quality of life, school, and family functioning. Yet, there is a lack of evidence-based community-centered rehabilitation programs for chronic pABI and these children do not systematically receive comprehensive rehabilitation. The Child In Context Intervention (CICI) study is a pragmatic randomized controlled trial (RCT) for children with chronic pABI, which aims to evaluate the effectiveness of an individualized and goal-oriented intervention targeting everyday functioning of the child and family. Methods Children aged 6–16 years with MRI/CT-verified intracranial abnormalities will be included in the CICI study if they have persistent self- or parent-reported cognitive, emotional, and/or behavioral challenges 1 year or more after insult and attend school regularly. A total of 70 families will be randomized 1:1 to an intervention or a control group. The intervention consists of seven family sessions, one parent seminar, and four school sessions delivered over approximately 6 months. The parent seminar will be held in person, and the other sessions will mainly be video based. The children’s and families’ self-reported major challenges in everyday life will be targeted using SMART goals. Evidence-based strategies, when available, will be applied to achieve the goals, combined with psychoeducation. Goal attainment scaling (GAS) will be used to evaluate goal attainment. Data is collected at baseline and after approximately 6 and 9 months. External assessors are blinded to group allocation. Primary outcomes are parent-reported brain injury symptoms in children and parenting self-efficacy at 9 months of follow-up. Secondary outcomes include child-reported brain injury symptoms, quality of life, executive functioning in daily life, parent emotional symptoms, family functioning, and unmet family health care needs. A process evaluation will be conducted. Discussion The current study provides an innovative approach to rehabilitation for children in the chronic phase of ABI and their families. This complex intervention may contribute to the development of evidence-based, high-quality rehabilitation for a large patient group, which is underrepresented in clinical research. It may also improve collaboration between specialized rehabilitation facilities, schools, and local health care services. Inclusion for the trial started in April 2021. Trial registration ClinicalTrials.gov NCT04798859 . Registered on March 15, 2021https://doi.org/10.1186/s13063-022-06048-8Pediatric brain injuryAcquired brain injuryGoal-orientedFamily interventionSchoolCommunity |
| spellingShingle | Nina Rohrer-Baumgartner Ingvil Laberg Holthe Edel Jannecke Svendsen Cecilie Røe Jens Egeland Ida M. H. Borgen Solveig L. Hauger Marit V. Forslund Cathrine Brunborg Hege Prag Øra Hilde Margrete Dahl Line Kildal Bragstad Eli Marie Killi Maria Sandhaug Ingerid Kleffelgård Anine Pernille Strand-Saugnes Ingeborg Dahl-Hilstad Jennie Ponsford Laraine Winter Shari Wade Marianne Løvstad Rehabilitation for children with chronic acquired brain injury in the Child in Context Intervention (CICI) study: study protocol for a randomized controlled trial Trials Pediatric brain injury Acquired brain injury Goal-oriented Family intervention School Community |
| title | Rehabilitation for children with chronic acquired brain injury in the Child in Context Intervention (CICI) study: study protocol for a randomized controlled trial |
| title_full | Rehabilitation for children with chronic acquired brain injury in the Child in Context Intervention (CICI) study: study protocol for a randomized controlled trial |
| title_fullStr | Rehabilitation for children with chronic acquired brain injury in the Child in Context Intervention (CICI) study: study protocol for a randomized controlled trial |
| title_full_unstemmed | Rehabilitation for children with chronic acquired brain injury in the Child in Context Intervention (CICI) study: study protocol for a randomized controlled trial |
| title_short | Rehabilitation for children with chronic acquired brain injury in the Child in Context Intervention (CICI) study: study protocol for a randomized controlled trial |
| title_sort | rehabilitation for children with chronic acquired brain injury in the child in context intervention cici study study protocol for a randomized controlled trial |
| topic | Pediatric brain injury Acquired brain injury Goal-oriented Family intervention School Community |
| url | https://doi.org/10.1186/s13063-022-06048-8 |
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