Skip to content

ERNIE: Evaluating Response to Individualized Neuropsychological Intervention for Children with Brain Tumors

ERNIE: Evaluating Response to Individualized Neuropsychological Intervention for Children with Brain Tumors - ERNIE study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56959
Enrollment
113
Registered
2024-05-16
Start date
2024-11-12
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropsychological deficits pediatric brain tumor Neuropsychological deficits, pediatric brain tumor

Interventions

In both the individualized and standardized interventions, cognitive and socio-emotional domains are addressed, with a maximum of 3 goals per patient. The intervention team provides psycho-education

Sponsors

Prinses Máxima Centrum voor Kinderoncologie
Lead Sponsor

Eligibility

Age
2 Years to 64 Years

Inclusion criteria

Inclusion criteria: Age between 8-17 years old Diagnosed with a primary brain tumor Completed treatment for a primary brain tumor (patients who are considered *wait and see* and have not received treatment will also be eligible) Experiencing cognitive problems (>=1SD below normative mean or >=1SD change over time on cognitive tests or cognitive questionnaires) A parent/caregiver who they have regular contact with to participate with them

Exclusion criteria

Exclusion criteria: No signed informed consent (either by patient and/or parents/legal guardian) Cannot complete neuropsychological assessment or questionnaires because they do not speak/understand the Dutch language Currently receiving palliative/end-of-life care Currently receiving other neuropsychological treatment • Severe developmental or psychiatric disorders and thus alternative interventions would be needed (e.g., autism spectrum disorder, schizophrenia, major depressive disorder) Significant sensory, motor, or developmental problems and thus alternative neuropsychological assessments would be needed (i.e., blindness, deafness, profound developmental delay FSIQ

Design outcomes

Primary

MeasureTime frame
As noted above, the same study parameters are used for both the primary and secondary objectives and therefore are described together here. The difference is that the primary objective uses parameters from the post-intervention phase (T2); whereas the secondary objective uses parameters from all phases (T1/T2/T3). The primary outcome measure will be goal attainment scaling (GAS), which is assessed through parent and patient interview. This method allows for scoring and tracking of an individual*s goals, but in a standardized format. Therefore, each participant has their own outcome measure, but the scaling is the same across participants to allow for statistical comparisons (i.e., T-score with M=50, SD=10). GAS scoring will be completed for both intervention groups, following established guidelines46.

Secondary

MeasureTime frame
Measurement of goal satisfaction through the Canadian Occupational Performance Measure (COPM). Measurements of daily functioning, cognitive, socio-emotional, quality of life, and family/parental domains > Neuropsychological tasks and questionnaires. See protocol table 2 for measurement instruments. Other parameters: Demographic/clinical data, medical history, family structure or support resources. Tertiary research parameters/endpoints: process evaluation (recruitment, accuracy and early-stage data collection, implementation, experiences, and facilitators/barriers)

Countries

Netherlands

Contacts

Public ContactM.H. Partanen

Prinses Máxima Centrum voor Kinderoncologie

m.h.partanen@prinsesmaximacentrum.nl003188 972 5206

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026