Clinical trial · Interventional
The Child in Context Intervention Study
Treating Chronic Symptoms of Pediatric Acquired Brain Injury - The Child In Context Intervention Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Diseases | — | UNRESOLVED | — |
| Brain Injuries | — | UNRESOLVED | — |
| Brain Injury, Chronic | — | UNRESOLVED | — |
| Child Behavior | — | UNRESOLVED | — |
| Childhood Brain Tumor | Childhood Brain Neoplasm | ALIAS | 0.90 |
| Family | — | UNRESOLVED | — |
| Parenting | — | UNRESOLVED | — |
| Rehabilitation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Other | — | UNRESOLVED |
| Family centered in-home rehabilitation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Family-centered in home rehabilitation
- description
- Seven individualized meetings with the family (7 sessions whereof most will be videoconferences, with the possibility of 1-2 of the sessions being home visits), one parent group seminar and 4 meetings (three videoconferences and one phone call) with school and local care providers during a period of 4-5 months. Based on target outcomes areas noted by children and parents, individual goals will be established (2-5 per family). Strategies to meet goals will be established for each goal, and goal attainment scaling will be used to quantify goal attainment.
- interventionNames
- Other: Family centered in-home rehabilitation
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Usual health care and rehabilitation services provided in the municipality, including school.
- interventionNames
- Other: Control
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * 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. 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 (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.
References
Publications (3)
- DERIVEDRohrer-Baumgartner N, Holthe IL, Svendsen EJ, Dahl HM, Borgen IMH, Hauger SL, Brunborg C, Ponsford J, Wade SL, Egeland J, Roe C, Lovstad M. Effects of an individualized and goal-oriented intervention in the chronic phase of pediatric acquired brain injury: the Child in Context Intervention (CICI)-a randomized controlled trial. BMC Pediatr. 2026 May 21;26(1):655. doi: 10.1186/s12887-026-06997-y. PMID 42168942
- DERIVEDHolthe IL, Rohrer-Baumgartner NM, Svendsen EJ, Roe C, Borgen IMH, Hauger SL, Ponsford JL, Egeland J, Wade S, Lovstad M. SMART-goal domains and goal attainment in an individualized, goal-oriented intervention for children with acquired brain injury and their families. Neuropsychol Rehabil. 2025 Jul;35(6):1229-1253. doi: 10.1080/09602011.2024.2402095. Epub 2024 Sep 16. PMID 39283234
- DERIVEDRohrer-Baumgartner N, Holthe IL, Svendsen EJ, Roe C, Egeland J, Borgen IMH, Hauger SL, Forslund MV, Brunborg C, Ora HP, Dahl HM, Bragstad LK, Killi EM, Sandhaug M, Kleffelgard I, Strand-Saugnes AP, Dahl-Hilstad I, Ponsford J, Winter L, Wade S, Lovstad M. Rehabilitation for children with chronic acquired brain injury in the Child in Context Intervention (CICI) study: study protocol for a randomized controlled trial. Trials. 2022 Feb 22;23(1):169. doi: 10.1186/s13063-022-06048-8. PMID 35193666