The Child in Context Intervention Study

NCT04798859 | Completed

• 1 other identifier: SunnaasRH_CICI226059
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pediatric brain injury; Randomized controlled trial (RCT); School; Family health care needs; Community

Outcome Measures

Primary Outcomes (2)

• Change in parent-reported severity of children's brain injury symptoms

  Assessed with the Health and Behavior Inventory (HBI) on a scale from 0 (Never) to 3 (Often), where higher score indicates more severe symptoms.

  Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)

• Change in parenting self-efficacy assessed with the assessment tool "Parenting Self-Efficacy (TOPSE)"

  The Tool to measure Parenting Self-Efficacy (TOPSE) is rated on a scale from 0 (completely disagree) to 10 (completely agree). Higher total score on the questionnaire indicates higher parenting self-efficacy.

  Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)

Secondary Outcomes (10)

• Change in child-reported severity of brain injury symptoms

  Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)

• Change in unmet healthcare needs of the family

  Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)

• Change in children's executive functioning in the home and school environment

  Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)

• Change in the children's quality of life

  Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)

• Change in family functioning

  Change from baseline (T1) to immediately after the intervention period (T2) and one year after baseline (T3)

Study Arms (2)

Family-centered in home rehabilitation

EXPERIMENTAL

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.

Other: Family centered in-home rehabilitation

Control group

ACTIVE COMPARATOR

Usual health care and rehabilitation services provided in the municipality, including school.

Other: Control

Interventions

Family centered in-home rehabilitation OTHER

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

Family-centered in home rehabilitation

Control OTHER

Usual follow-up in the municipality

Control group

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnaas Rehabilitation Hospital: lead
• The Research Council of Norway: collaborator
• Oslo University Hospital: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Monash University: collaborator
• The Hospital of Vestfold: collaborator

Study Sites (1)

Sunnaas Rehabilitaion Hospital

Nesoddtangen, Akershus, 1453, Norway

Location

Related Publications (2)

• Holthe 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 DERIVED

• Rohrer-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 DERIVED

MeSH Terms

Conditions

Brain Injuries; Brain Injury, Chronic; Brain Diseases; Child Behavior

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Damage, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Marianne Løvstad, PhD

  Sunnaas Rehabilitation Hospital and University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Independent Outcome Assessor(s) will be blinded to group allocation. Participants will be provided with new IDs in final database, blinding researchers to which group is the intervention group during analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 15, 2021
• Study Start: May 10, 2021
• Primary Completion: August 8, 2023
• Study Completion: December 6, 2023
• Last Updated: December 13, 2023

Record last verified: 2022-11

Locations

NO (1)