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The Child in Context Intervention Study

NCT04798859 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2023-12-13

No results posted yet for this 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 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.

Conditions

  • Rehabilitation
  • Brain Injuries
  • Brain Injury, Chronic
  • Brain Diseases
  • Family
  • Childhood Brain Tumor
  • Child Behavior
  • Parenting

Interventions

OTHER

Family centered in-home rehabilitation

Goal-oriented individualized intervention targeting brain injury related areas noted as challenging by the child and family

OTHER

Control

Usual follow-up in the municipality

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 and University of Oslo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-10
Primary Completion
2023-08-08
Completion
2023-12-06

Countries

  • Norway

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04798859 on ClinicalTrials.gov