Neoplasms

Nervous System Diseases

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Symptoms and General Pathology

Rare Diseases

Brain Neoplasms

Brain Injuries

Brain Diseases

Brain Injury, Chronic

Central Nervous System Diseases

Craniocerebral Trauma

Trauma, Nervous System

Brain Damage, Chronic

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Brain Tumor, Childhood

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.

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

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

Family centered in-home rehabilitation

Control

Marianne Løvstad, PhD

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.

There is considerable knowledge about how to help children with ABI during the first, acute and post-acute stages. Yet, impairments are often long lasting and, due to the vulnerability of children's developing brain, new problems may emerge or become increasingly problematic over time. Children with ABI may struggle at school and with peers, which can lead to or increase emotional difficulties, and reduce quality of life, affecting the children and their families. The local communities and the children's schools are, together with the families, often left responsible for dealing with the chronic challenges of pABI. Parents may experience considerable stress and develop emotional symptoms when a child suffers an ABI. As a result, the entire family may experience impaired functioning, which in turn may affect the long-term prognosis of the child with ABI.

Eighty families will be included in the study: 40 in the intervention group and 40 in the control group. The children will have a clinical ABI diagnosis, verified injury related intracranial abnormalities, and be at least one year post injury at inclusion. The children and/or their families must report enduring cognitive, emotional, social or physical challenges related to the brain injury. The intervention will be conducted in collaboration with the children's families, schools and their local health care providers. It consists of individualized goal-oriented strategies adapted to the home- and school-setting. Goal attainment scaling will be applied. In addition, psychoeducation will be provided to the family and school/local care providers on topics related to the child's injury. A parent group session will be held for discussions and knowledge transfer concerning family challenges after pABI, such as communication skills and parenting. The intervention will include 7 individualized meetings with the family (7 sessions whereof most will be videoconferences, but with the possibility of 1-2 of the sessions being home visits), one parent group seminar and 4 sessions with school and local health care providers during a period of 4-5 months.

Assessments will be conducted at baseline (T1), at the end of the intervention (T2, 4-5 months after inclusion) and one year after inclusion (T3). Baseline assessment includes a brief neuropsychological assessment of the children in addition to the outcome measures at T2 and T3. Outcome assessors will ble blinded to group allocation. Primary outcomes are change in parent-reported brain injury symptoms of the children and change in parenting self-efficacy. Secondary outcomes include change in child-rated severity of brain injury symptoms, change in unmet healthcare needs of the family, change in children's executive functioning in the home and school environment as assessed by parents, children and teachers, change in children's quality of life assessed by parents and children, change in family functioning, change in caregiver emotional symptoms, an evaluation of the intervention completed by parents, children and teachers in the intervention group, change in the perceived severity of the individually defined target outcome areas completed by children and parents, and change in goal attainment scaling in the intervention group.

The findings of this study will contribute to enhanced clinical expertise within pABI-rehabilitation on a specialist health care level, and will also be relevant for a wide array of health care professionals in the community as well as the educational system and parents of children with ABI.

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.

The Child in Context Intervention Study

Treating Chronic Symptoms of Pediatric Acquired Brain Injury - The Child In Context Intervention Study

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

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.

Assessed with the Family Needs Questionnaire - Pediatric version - FNQ-P on a scale from 1 (the need is not at all met) to 5 (completely met). Higher total score indicates higher level of met needs.

Assessed with the Behavior Rating Inventory of Executive Function 2 - BRIEF-2 on a 3-point scale: Never a problem, sometimes a problem or often a problem. Higher scaled score indicates higher level of problems with executive functioning.

Assessed with the Pediatric Quality of Life Inventory - Peds-QL scored on a scale from 0 (never a problem) to 4 (almost always a problem). Higher scaled score indicates higher quality of life.

Assessed with the family Assessment Device - FAD on a 4-point scale: Strongly agree, agree, disagree and strongly disagree. Lower total scaled score represents better family functioning.

Assessed with the Patient Health Questionnaire 9 - PHQ-9 on a scale from 0 (not at all) to 3 (almost every day). Higher mean score reflects a higher level of depressive symptoms.

Generalized Anxiety Disorder 7 - GAD-7 on a scale from from 0 (not at all) to 3 (almost every day). Higher mean score reflects a higher level of anxiety symptoms.

A custom-made evaluation questionnaire for the CICI Study will be completed by parents, children and teachers in the intervention group, as well as therapists. The Evaluation form is rated on a 5-point scale from "completely disagree" to "completely agree". Higher scaled score indicates higher degree of satisfaction.

Each of the participating family members (parent(s) and child) nominate their three most important problems (target outcome areas) and how difficult they find them on a scale from 0 (not at all difficult) to 4 (very difficult), where . changes in the difficulty scores are evaluated. A negative change indicates a decrease in perceived difficulty.

Goal Attainment Scaling (GAS) is assessed by GAS-scaling of individually defined goals (scale from 1 to 5). A higher positive change reflects higher level of goal attainment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Child in Context Intervention Study	NCT04798859	Rehabilitation Brain Injuries Brain Injury, C... Brain Diseases Family Childhood Brain... Child Behavior Parenting	Family centered... Control	6 Years - 16 Years	Sunnaas Rehabilitation Hospital
The Child in Context Intervention Study	NCT04798859	Rehabilitation Brain Injuries Brain Injury, C... Brain Diseases Family Childhood Brain... Child Behavior Parenting	Family centered... Control	6 Years - 16 Years	Sunnaas Rehabilitation Hospital

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