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

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.

Conditions

• Brain Injuries
• Brain Diseases
• Family
• Child

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

• The Research Council of Norway

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Monash University

  collaborator OTHER

• The Hospital of Vestfold

  collaborator OTHER

• Sunnaas Rehabilitation Hospital

  lead OTHER

Principal Investigators

• Marianne Løvstad, PhD · Sunnaas Rehabilitation Hospital, University of Oslo

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

6 Years

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-01

Primary Completion

2020-12-31

Completion

2021-01-31

Countries

• Norway

Study Locations