Treating Chronic Symptoms of Pediatric Acquired Brain Injury - a Feasibility Study
Condition: Brain Injuries; Brain Diseases; Family; Child
MeSH terms: Brain Injuries; Brain Diseases; 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 broad agreement that there is a lack of evidence-based knowledge about rehabilitation for
      children with ABI in the chronic phase. The current study is a feasibility study of a planned
      randomized controlled trial (RCT), the CICI-intervention, directed towards children with ABI
      and their families in the chronic phase. The feasibility study aims to evaluate the study
      protocol, the assessment procedures and the technical solutions prior to performing the RCT.

      A feasibility study with six participating children and families will be conducted in close
      collaboration with schools and local health care providers. The intervention to be tested
      (the CICI-intervention) focuses on the child's and family's individually identified target
      outcome areas to be addressed, with corresponding rehabilitation goals. The intervention aims
      to enhance everyday functioning in the home and school environment by reducing ABI-related
      symptoms, and by attaining rehabilitation goals in areas noted as challenging by the
      participants. In the future RCT-study the efficacy of the CICI-intervention will be measured
      in terms of goal attainment, community participation, cognitive, behavioral, social, 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 function, which in turn may affect the
      long-term prognosis of the child with ABI.

      In this feasibility study, six children between 6 and 15 years will be included. The children
      will have a clinical ABI diagnosis, verified injury related intracranial abnormalities, and
      be more than one year post injury at inclusion. The child and/or their family 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 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. Parent group sessions will be held for discussions and
      knowledge transfer concerning family challenges after a pABI, such as communication skills
      and parenting. The intervention will include 7 individualized meetings with the family (2
      home visits + 5 videoconferences), 2 parent group sessions and 4 meetings with school and
      local care providers during a period of 4-5 months.

      This feasibility study primarily aims to evaluate adherence to the CICI study protocol,
      responsiveness of participants and therapists, and the usefulness of the intervention.
      Furthermore, recruitment procedures, assessment protocol, goal setting and the technical
      solutions will be evaluated. A questionnaire developed for this project will be used to
      assess the families' satisfaction with the intervention as well as the acceptability of the
      intervention to families and therapists, while checklists, logs and qualitative interviews
      will be used to assess the remaining outcomes. Assessments in the future RCT will be
      conducted at baseline (T1), at the end of the intervention (T2, 4-5 months after inclusion)
      and one year after inclusion (T3). In the feasibility study, T1 and T2 will be included, as
      this is considered sufficient to evaluate feasibility of the study protocol as such.

      The primary outcomes of the CICI-intervention in the future RCT-study, will be:

        -  severity of brain injury symptoms (Health and Behavior Inventory - HBI),

        -  the child's quality of life (The Pediatric Quality of Life Inventory - Peds-QL), and

        -  parenting self-efficacy (Tool to Measure Parenting Self-Efficacy - TOPSE/Teens TOPSE).

      Secondary outcome measures of the CICI-intervention in the future RCT-study, will be:

        -  changes in self- and parental perceived severity of the individually defined target
           outcome areas (measured on a 5-point Likert scale),

        -  goal attainment scaling in the CICI group (Goal Attainment Scaling - GAS),

        -  emotional symptoms of the children (Child Behavior Checklist (CBCL), Teacher Report Form
           (TRF) and Youth Self-report (YSR))

        -  emotional symptoms of the parents (Patient Health Questionnaire 9 - PHQ-9 and
           Generalized Anxiety Disorder 7 - GAD-7),

        -  children's executive functioning in the home and school environment (Behavior Rating
           Inventory of Executive Function 2 - BRIEF-2),

        -  participation (The Child and Adolescent Scale of Participation - CASP),

        -  global outcome after pABI (Glasgow Outcome Scale Extended Pediatric Version - GOS-E
           Peds),

        -  parental stress (Parental Stress Scale - PSS)

        -  family functioning (Family Assessment Device - FAD), and

        -  unmet healthcare needs of the family (The Family Needs Questionnaire - Pediatric version
           - FNQ-P).

      In addition, the neuropsychological screening battery performed at baseline in the future
      RCT-study will consist of the following test measures: Similarities, Matrix Reasoning,
      Coding, Digit Span from the Wechsler Intelligence Scale for Children-V, Inhibition and
      Comprehension of Instructions from Nepsy-II, the Children's Communication Checklist-2
      questionnaire and the Children's Auditory Verbal Learning Test-2.

      October 27, 2020: This feasibility study was recruiting and in early stages when the Covid-19
      pandemic forced a halt in the study in March 2020. The insecurity of the situation caused us
      not to register the study as suspended, as we hoped from week to week that we would be able
      to continue. However, the pandemic resulted in a total halt, and reopening of the entire
      study in august 2020. The new timeline has been adjusted accordingly in the clinical
      trials.gov records.
    

Intervention name(s): CICI - Feasibility trial study group
Intervention type(s): Behavioral
Intervention description(s): The intervention will include 7 individualized meetings with the family (2 home visits + 5 videoconferences), 2 parent group sessions and 4 meetings with school and local care providers, delivered over a 4-5 month period.
Other intervention name(s): The CICI protocol
Intervention model: Single Group Assignment
Intervention model description: This is a feasibility trial evaluating the feasibility and acceptability of a planned randomized controlled trial. Therefore, no control group will be included.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rehabilitation