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 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.govNCT04798859. Registered on March 15, 2021

Unmet health care needs over the first 2 years after pediatric traumatic brain injury

“…In our health region, our research group is currently conducting a randomized controlled trial testing the efficacy of a goal-oriented rehabilitation program in the chronic phase of pediatric acquired brain injury. The study involves families and schools and includes qualitative research regarding acquired brain injury in childhood, the Child in Context Intervention (CICI) 114,115 .…”

The Long-Term Outcome and Rehabilitative Approach of Intraventricular Hemorrhage at Preterm Birth

“…22) Therefore, it is important to encourage physical activity through a multidisciplinary and integrated approach involving medical rehabilitation as well as social and family support. 19,83) Complication management is also needed. Patients with neuromotor disorders are very vulnerable to musculoskeletal chronic pain, which could adversely influence life satisfaction.…”

“…Nevertheless, across all ages and levels of motor function, young people with neuromotor impairments participated in 13–53% less habitual physical activity than able-bodied persons [ 21 ]. Therefore, it is important to encourage physical activity through a multidisciplinary and integrated approach involving medical rehabilitation as well as social and family support [ 18 , 82 ].…”