CPCog-Youth-DK: Cognitive Functioning in Children and Adolescents With Cerebral Palsy

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT05921422
Collaborator
Center for Rehabilitation of Brain Injury (Center for Hjerneskade) (Other), Aarhus University Hospital (Other), University of Copenhagen (Other)
150
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41
75
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Study Details

Study Description

Brief Summary

Background: Cerebral palsy (CP) is characterized by motor impairment but commonly involves more widespread difficulties, including cognitive impairment. However, cognitive impairment in CP - especially of a more subtle nature - is often overlooked, despite being associated with substantial academic, social, and emotional problems. In Denmark, the CP follow-up program (CPOP) includes systematic assessment of physical functions, but cognitive assessment is omitted. Prior to starting school, professionals evaluate the school readiness of children with CP, sometimes including a test of general cognitive functioning. Thereafter, cognitive assessments are rarely offered in mainstream schools (Folkeskolen) and can only be accessed if the difficulties are clearly disabling. Recent studies indicate that cognitive assessment needs to be implemented in the follow-up program for school children. For example, one study found that only 42% of students with CP complete mainstream school in Denmark, and international neurocognitive studies have found global cognitive difficulties (lower IQ) and specific impairments in visuo-spatial functions, executive functions, and processing speed in youth with CP. User organizations in the Nordic countries have called for action in recent years, leading to the development of a proposed cognitive follow-up program for children and adolescents with CP, the CPCog, which has yet to be evaluated and implemented in Denmark. Taken together, prior studies and patient experiences emphasize the need for systematic assessment of cognitive functioning in children and adolescents with CP to document the type and extent of cognitive difficulties, secure qualified intervention, and prevent the development of social and emotional problems.

Objective: The main purpose of this study is to characterize cognitive functioning in children and adolescents with CP in Danish mainstream schools. By documenting the extent and type of cognitive impairment associated with CP, we aim to inform future clinical practice and make recommendations for systematic assessment and intervention.

Method: The study is a cross-sectional study with 100 children and adolescents with CP (11-15 years). Each participant will undergo cognitive assessment with the core battery proposed in the Nordic CPCog protocol, including assessment of general cognitive functioning (intelligence), executive functions, and visuo-motor skills. Additionally, participants will undergo supplemental tests of memory, attention, fatigue, and symptoms of psychopathology. Cognitive assessments will take place at two sites: the Neurocenter for Children and Adolescents, Center for Rehabilitation of Brain Injury, and the Center for Clinical Neuropsychology, Children and Adolescents, Rigshospitalet, Copenhagen, Denmark. The project is carried out in collaboration between the neuropediatric and neuropsychological teams associated with the two sites of assessment, as well as the Center for Cerebral Palsy, Rigshospitalet, Aarhus University Hospital, CPOP, and an external advisory board including leading international CP experts.

Results: The CPCog-Youth-DK study will help characterize the cognitive difficulties associated with CP in children and adolescents in mainstream school, which will guide clinical practice and the development and implementation of systematic cognitive assessment and intervention programs. The cognitive assessment protocol will also be evaluated from the perspectives of children and adolescents with CP, parents, and professionals (e.g., assessors and school personnel) to evaluate whether the protocol is tolerable and helpful. Study results will be published in international, peer-reviewed journals, and will be made publicly available via other relevant platforms (such as the websites for the CP clinic at Rigshospitalet, Center for Rehabilitation of Brain Injury, and the Elsass Foundation). Several of the study investigators are directly involved in the current CP follow-up program in Denmark which will aid the process of turning our research into practice.

Condition or Disease Intervention/Treatment Phase
  • Other: Cognitive assessment

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Cognitive Functioning in Children and Adolescents With Cerebral Palsy
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Case group

Children and adolescents with cerebral palsy who are 11-15 years old, diagnosed with cerebral palsy (any type), and who attend a Danish mainstream school at time of enrollment

Other: Cognitive assessment
All participants will receive cognitive assessment with a core battery (CPCog) and a supplemental battery. The core battery includes standardized tests of general cognitive functioning (intelligence) and visual-spatial abilities, as well as a questionnaire on executive functioning in daily life. The supplemental battery assesses attention, executive functioning, memory, fatigue, and symptoms of mental health issues (including symptoms of anxiety, depression, and attention deficit hyperactivity disorder/ADHD).

Control group

Children and adolescents without cerebral palsy in the same age range as case-participants (11-15 years old) and attend Danish mainstream schools.

Other: Cognitive assessment
All participants will receive cognitive assessment with a core battery (CPCog) and a supplemental battery. The core battery includes standardized tests of general cognitive functioning (intelligence) and visual-spatial abilities, as well as a questionnaire on executive functioning in daily life. The supplemental battery assesses attention, executive functioning, memory, fatigue, and symptoms of mental health issues (including symptoms of anxiety, depression, and attention deficit hyperactivity disorder/ADHD).

Outcome Measures

Primary Outcome Measures

  1. Global cognitive functioning (IQ) [At first day of assessment]

    General cognitive functioning as measured by the GAI from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)

  2. Visuo-spatial functioning [At first day of assessment]

    Score from the Beery-Buktenica Developmental Test of Visual Motor Integration (Beery VMI)

  3. Executive functioning [At first day of assessment]

    Cognitive regulation index score from the Behavior Rating Inventory of Executive Function - second edition (BRIEF-2), parent version.

Secondary Outcome Measures

  1. Task switching ability [At second day of assessment]

    Number of correct words named on the D-KEFS verbal fluency task, and completion time in seconds on the D-KEFS Trail Making task

  2. Attention [At second day of assessment]

    Response sensitivity score (d') on the Test of Variables of Attention (T.O.V.A.)

  3. Verbal memory [At second day of assessment]

    Scale scores of selected verbal subtests (Word Selective Reminding; Object Recall) from 6the Test of Memory and Learning, Second edition (TOMAL-2)

  4. Visual memory [At second day of assessment]

    Scale scores of selected nonverbal subtests (Abstract Visual Memory; Visual Sequential Memory) from the Test of Memory and Learning, Second Edition (TOMAL-2)

  5. Working memory [At second day of assessment]

    Working Memory Index score from the WISC-V

Other Outcome Measures

  1. ADHD symptomatology [At second day of assessment]

    Total scores of inattention, hyperactivity, and behavior scales of the ADHD-rs questionnaire

  2. Symptoms of autism spectrum disorder [At second day of assessment]

    Index score from the Behavior Assessment System for Children, third edition (BASC-3), parent and child version

  3. Symptoms of emotional behavioral disturbance [At second day of assessment]

    Index score from the Behavior Assessment System for Children, third edition (BASC-3), parent and child version

  4. Fatigue [At second day of assessment]

    PedsQL MFS score

  5. Adaptive functioning [At second day of assessment]

    General Adaptive Composite (GAC) score from the Adaptive Behavior Assessment System, Third Edition (ABAS-3)

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
CASE GROUP:
Inclusion Criteria:
  • 11-15 years old

  • Diagnosed with CP (irrespective of type and severity)

  • Attends a Danish mainstream school at time of enrollment

Exclusion Criteria:
  • Does not speak or understand Danish at the level necessary to participate (as evaluated by the research team)
CONTROL GROUP:
Inclusion Criteria:
  • 11-15 years old

  • Attends a Danish mainstream school at time of enrollment

Exclusion Criteria:
  • Does not speak or understand Danish at the level necessary to participate (as evaluated by the research team)

  • Diagnosed with CP (irrespective of type and severity), traumatic brain injury or other neurological disorder (e.g., epilepsy)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rigshospitalet Copenhagen Denmark 2100
2 Center for Rehabilitation of Brain Injury (Center for Hjerneskade) Copenhagen Denmark 2300

Sponsors and Collaborators

  • Rigshospitalet, Denmark
  • Center for Rehabilitation of Brain Injury (Center for Hjerneskade)
  • Aarhus University Hospital
  • University of Copenhagen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Camilla Funch Uhre, MSc, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT05921422
Other Study ID Numbers:
  • P-2023-155
First Posted:
Jun 27, 2023
Last Update Posted:
Jun 27, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2023