NCT04798859: CICI

The Child in Context Intervention Study

Completed NA Last updated 13 December 2023

What this trial tests

NA trial testing Family centered in-home rehabilitation in Rehabilitation in 58 participants. Completed in 6 December 2023.

Timeline

10 May 2021

Primary endpoint
8 August 2023

6 December 2023

Quick facts

Lead sponsor	Sunnaas Rehabilitation Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	58
Start date	10 May 2021
Primary completion	8 August 2023
Estimated completion	6 December 2023
Sites	1 location across Norway

Drugs / interventions tested

• Family centered in-home rehabilitation
• Control

Conditions studied

• Rehabilitation — all drugs for Rehabilitation →
• Brain Injuries — all drugs for Brain Injuries →
• Brain Injury, Chronic — all drugs for Brain Injury, Chronic →
• Brain Diseases — all drugs for Brain Diseases →

Sponsor

Sunnaas Rehabilitation Hospital

Who can join

Adults 6 to 16, any sex, with Rehabilitation or Brain Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Rehabilitation for children with chronic acquired brain injury in the Child in Context Intervention (CICI) study: study protocol for a randomized controlled trial.
   Rohrer-Baumgartner N, Holthe IL, Svendsen EJ, Røe C, et al · · 2022 · cited 15× · PMID 35193666 · DOI 10.1186/s13063-022-06048-8
2. SMART-goal domains and goal attainment in an individualized, goal-oriented intervention for children with acquired brain injury and their families.
   Holthe IL, Rohrer-Baumgartner NM, Svendsen EJ, Røe C, et al · · 2025 · cited 1× · PMID 39283234 · DOI 10.1080/09602011.2024.2402095
3. 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.
   Rohrer-Baumgartner N, Holthe IL, Svendsen EJ, Dahl HM, et al · · 2026 · PMID 42168942 · DOI 10.1186/s12887-026-06997-y