Treating Chronic Symptoms of Pediatric Acquired Brain Injury - a Feasibility Study

NCT04186182 | Completed

• 1 other identifier: SunnaasRH
• Study Type: interventional
• Target: 6
• 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 broad agreement that there is a lack of evidence-based knowledge about rehabilitation for children with ABI in the chronic phase. The current study is a feasibility study of a planned randomized controlled trial (RCT), the CICI-intervention, directed towards children with ABI and their families in the chronic phase. The feasibility study aims to evaluate the study protocol, the assessment procedures and the technical solutions prior to performing the RCT. A feasibility study with six participating children and families will be conducted in close collaboration with schools and local health care providers. The intervention to be tested (the CICI-intervention) focuses on the child's and family's individually identified target outcome areas to be addressed, with corresponding rehabilitation goals. The intervention aims to enhance everyday functioning in the home and school environment by reducing ABI-related symptoms, and by attaining rehabilitation goals in areas noted as challenging by the participants. In the future RCT-study the efficacy of the CICI-intervention will be measured in terms of goal attainment, community participation, cognitive, behavioral, social, and family functioning.

Conditions

Brain Injuries; Brain Diseases; Family; Child

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (5)

• Protocol adherence assessed by study-specific checklists

  The therapists will monitor discrepancies between intervention delivery and the CICI-manual by using extensive checklists relating to each of the intervention sessions. The number of non-delivered treatment components will be counted, and the percentage of deviation will be calculated compared to the total number of treatment components. High feasibility: 15 % deviation or less, Moderate feasibility: 15-25 % deviation, Low feasibility: \> 25 % deviation

  Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.

• Child Responsiveness to the intervention assessed by ratings on the study specific Acceptability Scale.

  The acceptability Scale is rated on a scale from 0 ("Completely disagree") to 4 ("Completely agree"). The total mean score on the Responsiveness subscale (6 items) on the Acceptability Scale, rated by the child, will determine child responsiveness. The responsiveness subscale consists of the following items (the wording adapted to the child's age): I would recommend participating in the study to others, the therapist was warm and understanding, I trusted the therapist, I had the opportunity to state my opinions about the therapist's suggestions, my opinions were taken seriously, I was given sufficient information during the study about the work we were doing. High feasibility: Mean score ≥ 3 ("Agree"), Moderate feasibility: Mean score ≥ 2 and \< 3, Low feasibility: \< 2.

  Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.

• Caregiver Responsiveness to the intervention assessed by ratings on the study specific Acceptability Scale.

  The acceptability Scale is rated on a scale from 0 ("Completely disagree") to 4 ("Completely agree"). The total mean score on the Responsiveness subscale (6 items) on the Acceptability Scale, rated by the caregiver, will determine caregiver responsiveness. The responsiveness subscale consists if the following items: I would recommend participating in the study to others, the therapist was warm and understanding, I trusted the therapist, I had the opportunity to state my opinions about the therapist's suggestions, my opinions were taken seriously, I was given sufficient information during the study about the work we were doing. High feasibility: Mean score ≥ 3 ("Agree"), Moderate feasibility: Mean score ≥ 2 and \< 3, Low feasibility: \< 2.

  Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.

• a. Usefulness of the intervention assessed by child ratings on the study-specific Acceptability Scale for this study

  The acceptability Scale is rated on a scale from 0 ("Completely disagree") to 4 ("Completely agree"). The total mean score on the Usefulness subscale (6 items) in the Acceptability Scale will determine perceived usefulness of the intervention. The child version of the usefulness subscale consists of the following items: The program has helped me, the program has helped my family, I would recommend participating in the program to others, I have learned something new that helps me, I have learned more about what I struggle with after the injury, I have learned what I can say to others about what I struggle with due to the injury. High feasibility: Mean score ≥ 3 ("Agree"), Moderate feasibility: Mean score ≥ 2 and \< 3, Low feasibility: \< 2.

  Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.

• b. Usefulness of the intervention assessed by caregiver ratings on the study-specific Acceptability Scale for this study.

  The acceptability Scale is rated on a scale from 0 ("Completely disagree") to 4 ("Completely agree"). The total mean score on the Usefulness subscale (9 items) in the Acceptability Scale will determine perceived usefulness of the intervention. The caregiver version of the usefulness subscale consists of the following items: The program has helped my child, the program has helped my family, the program has helped me, I would recommend participating in the program to others, I have gained more insight into my child´s challenges, I will use my new knowledge in the future, I have used my new knowledge in other settings, I found it useful to meet other families who are in a similar situation as we are, the school meetings were useful. High feasibility: Mean score ≥ 3 ("Agree"), Moderate feasibility: Mean score ≥ 2 and \< 3, Low feasibility: \< 2.

  Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.

Secondary Outcomes (15)

• Recruitment procedures assessed by a) consent rate

  Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.

• Recruitment procedures assessed by b) duration of phone calls and screening interview per family

  Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.

• Recruitment procedures assessed by c) the number of participants excluded at or after baseline

  Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.

• Recruitment procedures assessed by d) the number of families that completed the whole intervention

  Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.

• The burden of the assessment protocol for the child, reported by the child on the study-specific Acceptability Scale.

  Will be evaluated after the intervention period, i.e. 4-5 months after inclusion.

Study Arms (1)

CICI - Feasibility trial study group

OTHER

The feasibility of the entire CICI-protocol will be evaluated. See details above.

Behavioral: CICI - Feasibility trial study group

Interventions

CICI - Feasibility trial study group BEHAVIORAL

The intervention will include 7 individualized meetings with the family (2 home visits + 5 videoconferences), 2 parent group sessions and 4 meetings with school and local care providers, delivered over a 4-5 month period.

Also known as: The CICI protocol

CICI - Feasibility trial study group

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• School-aged (6-15 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: 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 and willing to actively participate in a goal-oriented approach

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.
• Patients with severe psychiatric illness or children with injuries so severe that they are in institutionalized care.
• Children in custody of the child protection services.
• Parental severe psychiatric illness, drug abuse or indications of a history of or risk of domestic violence.
• The family is not fluent in Norwegian

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 rehabilitation hospital

Nesoddtangen, 1453, Norway

Location

Related Publications (1)

• Svendsen EJ, Killi EM, Rohrer-Baumgartner N, Holthe IL, Sandhaug M, Borgen IMH, Wade SL, Hauger SL, Lovstad M, Bragstad LK. Children's, parents', and teachers' experiences of the feasibility of a telerehabilitation intervention for children with acquired brain injury in the chronic phase - a qualitative study of acceptability and participation in the Child In Context Intervention (CICI). BMC Health Serv Res. 2023 Jun 8;23(1):603. doi: 10.1186/s12913-023-09589-z.

  PMID: 37291543 DERIVED

MeSH Terms

Conditions

Brain Injuries; Brain Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Marianne Løvstad, PhD

  Sunnaas Rehabilitation Hospital, University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a feasibility trial evaluating the feasibility and acceptability of a planned randomized controlled trial. Therefore, no control group will be included.

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: December 4, 2019
• Study Start: August 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: January 31, 2021
• Last Updated: February 8, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)