Treating Chronic Symptoms of Pediatric Acquired Brain Injury - a Feasibility Study

NCT ID: NCT04186182

Last Updated: 2021-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-01-31

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.

Conditions

Brain Injuries; Brain Diseases; Family; Child

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CICI - Feasibility trial study group

The feasibility of the entire CICI-protocol will be evaluated. See details above.

Group Type: OTHER

CICI - Feasibility trial study group

Intervention Type: BEHAVIORAL

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.

Interventions

CICI - Feasibility trial study group

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

The CICI protocol

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Research Council of Norway

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: collaborator

Monash University

OTHER

Sponsor Role: collaborator

The Hospital of Vestfold

OTHER

Sponsor Role: collaborator

Sunnaas Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marianne Løvstad, PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnaas Rehabilitation Hospital, University of Oslo

Locations

Sunnaas rehabilitation hospital

Nesoddtangen, , Norway

Countries

Norway

References

Svendsen EJ, Killi EM, Rohrer-Baumgartner N, Holthe IL, Sandhaug M, Borgen IMH, Wade SL, Hauger SL, Lovstad M, Bragstad LK. Children's, parents', and teachers' experiences of the feasibility of a telerehabilitation intervention for children with acquired brain injury in the chronic phase - a qualitative study of acceptability and participation in the Child In Context Intervention (CICI). BMC Health Serv Res. 2023 Jun 8;23(1):603. doi: 10.1186/s12913-023-09589-z.

Reference Type: DERIVED

PMID: 37291543 (View on PubMed)

Other Identifiers

SunnaasRH

Identifier Type: -

Identifier Source: org_study_id