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An individualized neuropsychological intervention for children post brain tumor treatment

ERNIE: Evaluating Response to iNdividualized neuropsychological IntervEntion for children with brain tumors

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN30985676
Enrollment
144
Registered
2024-10-04
Start date
2024-10-01
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Neuropsychological problems in children who finished treatment for a primary brain tumor Mental and Behavioural Disorders

Interventions

In this RCT, participants and their parents will be randomized using an online tool to the individualized intervention arm or standardized intervention arm. Participants will be blinded to their treat

Sponsors

Princess Máxima Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1. Age between 8-17 years old 2. Diagnosed with a primary brain tumor 3. Completed treatment for a primary brain tumor (patients who are considered “wait and see” and have not received treatment will also be eligible) 4. Experiencing cognitive problems (=1SD below normative mean or estimated IQ [EIQ]) on =2 scores, including WISC-V/WAIS-IV, IDS2, CPT3, 15WT tests and/or self- or proxy-reported PedsQL Fatigue or BRIEF-2 questionnaires) 5. A parent/caregiver who they have regular contact (in order to participate in the intervention with them)

Exclusion criteria

Exclusion criteria: 1. No signed informed consent (either by patient and/or parents/legal guardian) 2. Cannot complete neuropsychological assessment or questionnaires because they do not speak/understand the Dutch language 3. Currently receiving palliative/end-of-life care 4. Currently receiving other neuropsychological treatment 5. Severe developmental or psychiatric disorders and thus alternative interventions would be needed (e.g., autism spectrum disorder, schizophrenia, major depressive disorder) 6. Significant sensory, motor, or developmental problems and thus alternative neuropsychological assessments would be needed (i.e., blindness, deafness, profound developmental delay FSIQ <55) 7. Treating physician or psychologist advises against inclusion

Design outcomes

Primary

MeasureTime frame
Goal attainment is measured using Goal Attainment Scaling (GAS) at baseline, 3 months and 12 months follow-up

Secondary

MeasureTime frame
1. Neuropsychological assessment tasks: 1.1 Estimated Intelligent Quotient (IQ) measured using the Vocabulary and Matrix Reasoning subtests from Weschler Intelligence Scale for Children-V (WISC-V)/Weschler Adult Intelligence Scale-IV (WAIS-IV) at baseline and 12 months follow-up 1.2 Working memory measured using the Digit Span from WISC-V/WAIS-IV at baseline and 12 months follow-up 1.3. Processing speed measured using the Coding from WISC-V/WAIS-IV at baseline and 12 months follow-up 1.4. Executive functioning measured using the subtests Road Walking from the Intelligence and Development Scales-2 (IDS-2) at baseline and 12 months follow-up 1.5. Memory measured using Rey Auditory Verbal Learning Test (RAVLT) at baseline and 12 months follow-up 1.6. Sustained attention measured using Continuous Performance Test-3 (CPT-3) at baseline and 12 months follow-up 1.7 Social functioning measured using IDS-2 Socially Competent Behavior task at baseline and 12 months follow-up 2. Questionnaires filled out by parents and/or patients: 2.1 Adaptive behavior measured by the Adaptive Behavior Assessment System – Third Edition (ABAS-3) at baseline, 3 months and 12 months follow-up 2.2 Executive functioning in daily life measured by the Behavior Rating of Executive Function-2 (BRIEF-2) at baseline, 3 months and 12 months follow-up 2.3 Fatigue measured by the Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL-MFS) at baseline, 3 months and 12 months follow-up 2.4 Emotional problems measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depressive Symptoms Short Forms 3.0 at baseline, 3 months and 12 months follow-up 2.5 Social functioning measured by the PROMIS Peer Relationships short form 3.0 at baseline, 3 months and 12 months follow-up 2.6 Parental stress measured by the Distress Thermometer for Parents (DT-P) at baseline, 3 months and 12 months follow-up 2.7 Socioeconomic status, birth, developmental, psychiatric,

Countries

Netherlands

Contacts

Public ContactMarita Partanen
m.h.partanen@prinsesmaximacentrum.nl+31 (0)88 97 25 844

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026