Cognitive Rehabilitation in Pediatric Acquired Brain Injury

NCT03215342 | Completed DMC

• 1 other identifier: 2017/772
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

Acquired brain injury (e.g., traumatic brain injury, brain tumour, brain infections) is one of the leading causes of death and disability for children and adolescents. Importantly, injuries affecting the brain in childhood or adolescence appear during a time of development when the brain is particularly vulnerable. Thus, pediatric acquired brain injury does not only impact cognitive functions at the time of injury or onset of disease, but also cognitive functions that are yet to develop. Changes in cognitive function, and in particular executive dysfunction due to acquired brain injury, cause significant real-life disability, yet solid evidence in support of executive functioning interventions for children and adolescents is lacking. In the present study different group-based cognitive rehabilitation interventions will be compared. The aim of the study is to investigate if a group-based "brain training" intervention is able to improve executive function in children and adolescents after acquired brain injury. Efficacy will be assessed immediately after intervention, but also six months after the intervention. The project is in line with international research efforts aimed at establishing more knowledge about how children and adolescents with brain injuries respond to cognitive rehabilitation.

Conditions

Brain Injuries

Keywords

Child; Rehabilitation; Psychotherapy, groups

Outcome Measures

Primary Outcomes (1)

• executive function in daily life

  Behavior Rating Inventory of Executive Function (BRIEF; self, teacher and parent form

  change from baseline up to 6 months

Secondary Outcomes (16)

• Performance on Conners Continuous Performance Test III

  change from baseline up to 6 months

• Performance on BADS-C

  change from baseline up to 6 months

• Performance on D-KEFS Trail Making Test 1-4

  change from baseline up to 6 months

• performance on D-KEFS Color Word Interference Test

  change from baseline up to 6 months

• Performance on Children's Cooking Task test

  change from baseline up to 6 months

Study Arms (2)

pGMT

EXPERIMENTAL

Pediatric Goal Management Training

Behavioral: Pediatric Goal Management Training

pBHW

EXPERIMENTAL

Pediatric Brain Health Workshop

Behavioral: Pediatric Brain Health Workshop

Interventions

Pediatric Goal Management Training BEHAVIORAL

7 GMT modules will be administered in 7x2 hours sessions (ten groups). Manualized intervention; metacognitive strategies for improving attention and problem solving. Homework assignments between sessions.

Also known as: GMT

pGMT

Pediatric Brain Health Workshop BEHAVIORAL

7 pBHW modules will be administered in 7x2 hours sessions (ten groups). Psychoeducation; brain (dys)function, plasticity, memory, executive function, and attention. Stress, physical exercise, sleep, nutrition, and energy management. Homework assignments between sessions

Also known as: active control condition, pBHW

pBHW

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• diagnosed with traumatic brain injury, brain tumor or damage by inflammation in the brain
• more than 12 months since injury/illness or more than 12 months since ended cancer therapy
• evidence of executive dysfunction in everyday life

You may not qualify if:

• cognitive, sensory, physical, or language impairment affecting the capacity to attend mainstream school and/or complete the training program
• pre-injury neurological disease or psychiatric disorder
• recently detected brain tumor relapse
• unfit for evaluation of outcome (independent evaluation by 2 investigators)
• not fluent in Norwegian language

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Oslo University Hospital: collaborator

Study Sites (2)

Oslo universitetssykehus HF

Oslo, Norway

Location

Barne og ungdomsklinikken St Olavs Hospital

Trondheim, Norway

Location

Related Publications (4)

• Hypher RE, Brandt AE, Risnes K, Ro TB, Skovlund E, Andersson S, Finnanger TG, Stubberud J. Paediatric goal management training in patients with acquired brain injury: study protocol for a randomised controlled trial. BMJ Open. 2019 Aug 1;9(8):e029273. doi: 10.1136/bmjopen-2019-029273.

  PMID: 31375619 BACKGROUND

• Brandt AE, Finnanger TG, Hypher RE, Ro TB, Skovlund E, Andersson S, Risnes K, Stubberud J. Rehabilitation of executive function in chronic paediatric brain injury: a randomized controlled trial. BMC Med. 2021 Nov 2;19(1):253. doi: 10.1186/s12916-021-02129-8.

  PMID: 34724955 RESULT

• Hypher R, Brandt AE, Skovlund E, Skarbo AB, Barder HE, Andersson S, Ro TB, Risnes K, Finnanger TG, Stubberud J. Metacognitive strategy training versus psychoeducation for improving fatigue in children and adolescents with acquired brain injuries: A randomized controlled trial. Neuropsychology. 2022 Oct;36(7):579-596. doi: 10.1037/neu0000845. Epub 2022 Aug 4.

  PMID: 35925734 DERIVED

• Hypher R, Andersson S, Finnanger TG, Brandt AE, Hoorelbeke K, Lie HC, Barder HE, Larsen SM, Risnes K, Ro TB, Stubberud J. Fatigue following pediatric acquired brain injury: Interplay with associated factors in a clinical trial population compared to healthy controls. Neuropsychology. 2021 Sep;35(6):609-621. doi: 10.1037/neu0000753. Epub 2021 Jul 1.

  PMID: 34197132 DERIVED

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Kari Risnes, md phd

  St. Olavs Hospital

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 12, 2017
• Study Start: December 1, 2017
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: December 14, 2021

Record last verified: 2021-12

Locations

NO (2)