Clinical trial NCT04186182: Treating Chronic Symptoms of Pediatric Acquired Brain Injury - a Feasibility Study
Official title: The Child-In-Context-Intervention (CICI): The Feasibility of a Study Protocol for Treatment of Chronic Symptoms of Pediatric Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Brain Diseases
Family
Child
Keywords: Rehabilitation
Lead sponsor: Sunnaas Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: Oslo University Hospital
name: Children's Hospital Medical Center, Cincinnati
name: Monash University
name: The Hospital of Vestfold
First posted: 2019-12-04
Enrollment: 6
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* School-aged (6-15 years) children with clinical ABI-diagnosis and CT/MRI verified injury-related intracranial abnormalities, 1 year or more after injury. We anticipate including patients with the following etiologies: TBI, cerebrovascular incidents, anoxia, encephalitis and non-progressive brain tumors.
* 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 and willing to actively participate in a goal-oriented approach

Exclusion Criteria:

* Patients with severe pre- or comorbid neurological or neuropsychiatric disorders that would confound assessment and/or treatment outcomes.
* Patients with brain tumors in active treatment or at great risk of relapse.
* Patients with severe psychiatric illness or children with injuries so severe that they are in institutionalized care.
* Children in custody of the child protection services.
* Parental severe psychiatric illness, drug abuse or indications of a history of or risk of domestic violence.
* The family is not fluent in Norwegian

Primary outcomes:
measure: Protocol adherence assessed by study-specific checklists
timeFrame: Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.
measure: Child Responsiveness to the intervention assessed by ratings on the study specific Acceptability Scale.
timeFrame: Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.
measure: Caregiver Responsiveness to the intervention assessed by ratings on the study specific Acceptability Scale.
timeFrame: Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.
measure: a. Usefulness of the intervention assessed by child ratings on the study-specific Acceptability Scale for this study
timeFrame: Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.
measure: b. Usefulness of the intervention assessed by caregiver ratings on the study-specific Acceptability Scale for this study.
timeFrame: Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.
Secondary outcomes:
measure: Recruitment procedures assessed by a) consent rate
timeFrame: Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.
measure: Recruitment procedures assessed by b) duration of phone calls and screening interview per family
timeFrame: Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.
measure: Recruitment procedures assessed by c) the number of participants excluded at or after baseline
timeFrame: Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.
measure: Recruitment procedures assessed by d) the number of families that completed the whole intervention
timeFrame: Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.
measure: The burden of the assessment protocol for the child, reported by the child on the study-specific Acceptability Scale.
timeFrame: Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.
measure: The burden of the assessment protocol for the child, reported by caregivers on the study-specific Acceptability Scale.
timeFrame: Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.
measure: The burden of the assessment protocol for the caregivers, reported by caregivers on the study-specific Acceptability Scale.
timeFrame: Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.
measure: Caregiver reported relevance of topics in questionnaires
timeFrame: Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.
measure: Therapist reported burden of the baseline assessment measured by the duration of the assessment.
timeFrame: Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.
measure: The perceived relevance of working with SMART-goals as rated by caregivers on the study-specific Acceptability Scale.
timeFrame: Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.
measure: The perceived relevance of working with SMART-goals rated by the child on the study-specific Acceptability Scale.
timeFrame: Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.
measure: Therapist-recorded technical failures in using videoconference in treatment delivery assessed by a study-specific log.
timeFrame: Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.
measure: Therapist-recorded time spent on installment of the equipment for using videoconference in treatment delivery
timeFrame: Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.
measure: Experienced quality of communication in using videoconference in treatment delivery, assessed by the Acceptability scale.
timeFrame: Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.
measure: Semi-structured qualitative interviews with all participating children, caregivers and teachers will be conducted to elaborate aspects of feasibility as described above.
timeFrame: Will be performed after the intervention period, i.e. 4-5 months after inclusion.
Other outcomes:
Locations:
city: Nesoddtangen
country: Norway
facility: Sunnaas rehabilitation hospital
Study officials:
affiliation: Sunnaas Rehabilitation Hospital, University of Oslo
name: Marianne Løvstad, PhD
role: PRINCIPAL_INVESTIGATOR
References: