NCT04798859Completed
The Child in Context Intervention Study
Treating Chronic Symptoms of Pediatric Acquired Brain Injury - The Child In Context Intervention Study
Source: ClinicalTrials.gov · Last updated 13 Dec 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 58 (actual)
- First submitted
- 2 Mar 2021
- Start date
- 10 May 2021
- Primary completion date
- 8 Aug 2023
- Lead sponsor
- Sunnaas Rehabilitation Hospital
- Diseases
- Childhood cancers
- NCT number
- NCT04798859
What you commit to
- Study type: Interventional
- Participants enrolled: 58
- From 10 May 2021 to the primary completion date, 8 Aug 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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 (i.e., unstable condition).
- Patients with severe psychiatric illness or children with injuries so severe that they are in institutionalized care most of the time.
- Parental severe psychiatric illness, drug abuse or indications of a history of or risk of domestic violence.
Who the study is looking for
- School-aged (6-16 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: Traumatic brain injury (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 to actively participate in a goal-oriented approach, this includes speaking sufficiently Norwegian. An exception can be made for parents who speak English but are able to understand and read Norwegian.
Age in the registry: 6 years to 16 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnaas Rehabilitaion Hospital Coordinator of this site? Confirm its status | Nesoddtangen | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.