The Child in Context Intervention Study
Condition: Rehabilitation; Brain Injuries; Brain Injury, Chronic; Brain Diseases; Family; Childhood Brain Tumor; Child Behavior; Parenting
MeSH terms: Brain Injuries; Brain Diseases; Brain Injury, Chronic; Wounds and Injuries
Study type: Interventional

Summary: 
      Children with acquired brain injury (ABI) often struggle with complex impairments, including
      cognitive (such as memory and attention), social, emotional and behavioral challenges. There
      is a lack of evidence-based knowledge about rehabilitation for children with ABI in the
      chronic phase. The current study, the CICI Study, is a randomized controlled trial (RCT)
      directed towards children with ABI and their families in the chronic phase.

      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: 
      There is considerable knowledge about how to help children with ABI during the first, acute
      and post-acute stages. Yet, impairments are often long lasting and, due to the vulnerability
      of children's developing brain, new problems may emerge or become increasingly problematic
      over time. Children with ABI may struggle at school and with peers, which can lead to or
      increase emotional difficulties, and reduce quality of life, affecting the children and their
      families. The local communities and the children's schools are, together with the families,
      often left responsible for dealing with the chronic challenges of pABI. Parents may
      experience considerable stress and develop emotional symptoms when a child suffers an ABI. As
      a result, the entire family may experience impaired functioning, which in turn may affect the
      long-term prognosis of the child with ABI.

      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.
    

Intervention name(s): Family centered in-home rehabilitation; Control
Intervention type(s): Other; Other
Intervention description(s): Goal-oriented individualized intervention targeting brain injury related areas noted as challenging by the child and family; Usual follow-up in the municipality
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatric brain injury; Randomized controlled trial (RCT); School; Family health care needs; Community