- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02573441
NYCKLAR för att lyckas: Kognitivt och akademiskt interventionsprogram för barn och ungdomar som överlever cancer
The study will examine whether school liaison services and home-based parental tutoring can help with academic difficulties of paediatric brain tumour survivors who received cranial spinal radiation and have returned to school. Forty-five patients will participate in the project. All patients will receive psychology liaison services to link resources at the hospital with those in the community. Patients will participate in one of two tutoring programs designed to directly or indirectly improve math skills over 12 weeks. Weekly phone calls will be used to support parents using the program. Patients will be tested before, immediately after, and six months following each tutoring program to assess growth in mathematics and working memory abilities.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Paediatric brain tumour survivors who receive cranial spinal radiation have learning problems, particularly in mathematics and working memory. Working memory is often described as a "mental workspace" where relevant information is held in mind and processed. Working memory is important in mathematics for holding in mind relevant information and carrying out steps necessary to solve problems.
This study will examine whether school liaison support and home-based parental tutoring can help address the academic difficulties of paediatric brain tumour survivors who have received cranial spinal radiation and who have returned to their community school. Forty five patients will participate in the project. First, all patients will receive psychology liaison services to link resources at the hospital with those in the community in order to provide information regarding the effects of pediatric cancer on learning and facilitate the implementation of appropriate assistive technology and remediation programs. Patients will then participant in one of two tutoring programs over the course of a 12 week period. One group of patients will participate in a program that addresses working memory with the intent of indirectly helping with mathematics skills. This program will be delivered over the internet. Another group of patients will participate in a program using a work book to directly help improve mathematics skills. Weekly phone calls will be used to support parents in doing the program. Patients will be tested before, immediately after, and six months following each tutoring program to assess growth in mathematics and working memory abilities. The two intervention programs will be compared to a waitlist control group that receives only the liaison service (including academic support through weekly phone calls over the 12 weeks).
The findings from this study will provide evidence about the type of intervention that is most effective at helping paediatric brain tumour survivors improve their mathematics skills and working memory ability.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Ontario
-
Toronto, Ontario, Kanada, M5G 1X8
- Hospital for Sick Children
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Has been diagnosed with a brain tumour and treated with cranial radiation
- Is between 1 and 10 years following diagnosis
- Has English as his or her native language or has had at least two years of schooling in English
- Is between the ages of 6 and 17
- Less than a Grade 8 equivalent math score
Exclusion Criteria:
- Is younger than 6 years or older than 17 years of age
- Is receiving palliative care
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Math + Liaison Service
To help with mathematics, participants will be assigned to a workbook based version of the JUMP Math program which will be completed at home with a parent. This intervention focuses on mental math skills. In addition all participants will receive the liaison service program. |
Jump Math is a workbook based program aimed at improving math skills Liaison Services will include working closely with schools to help explain the strengths and weaknesses of a child based on cognitive testing and to help with the implementation of recommendations |
|
Experimentell: Working Memory + Liaison Service
To help with working memory, participants will be assigned to Cogmed, a game-like computer exercise focusing on improving working memory. In addition all participants will receive the liaison service program. |
Liaison Services will include working closely with schools to help explain the strengths and weaknesses of a child based on cognitive testing and to help with the implementation of recommendations Cogmed is an online computer program aimed at improving working memory skills |
|
Övrig: Liaison Services
Participants in this group will only receive the liaison service program for 12 weeks before being assigned to one of the intervention groups. |
Liaison Services will include working closely with schools to help explain the strengths and weaknesses of a child based on cognitive testing and to help with the implementation of recommendations |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Woodcock Johnson Academic-Third Edition
Tidsram: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of math Fluency, applied math problems, and qualitative concepts |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
Wechsler Intelligence Scale for Children - Fourth Edition Integrated
Tidsram: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of verbal and visual working memory |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
Wide Range Assessment of Memory and Learning - Second Edition
Tidsram: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of verbal and visual working memory |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
Automated Working Memory Assessment
Tidsram: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of verbal and visual working memory |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
Connors' Continuous Performance Test-Second Edition
Tidsram: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of sustained attention |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
Behaviour Rating Inventory of Executive Function-Parent Version
Tidsram: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of executive functioning |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
Monitoring Basic Skills Progress
Tidsram: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of mathematics |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
SAM
Tidsram: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of participants attitude towards math |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
Wide Range Assessment of Memory and Learning - Second Edition
Tidsram: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of visual learning and memory |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
California Verbal Learning Test, Children's Version
Tidsram: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of verbal learning and memory |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
CANTAB
Tidsram: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
Measures of processing speed |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
Wechsler Abbreviated Scale of Intelligence - Second Edition
Tidsram: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of vocabulary and abstract visual reasoning |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
Delis-Kaplan Executive Function System
Tidsram: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
Measures of processing speed and switching attention |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Donald Mabbott, Ph.D., The Hospital for Sick Children
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Beräknad)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 1000043747
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