Lymphoma Clinical Trial
Official title:
Assessing Implementation and Effectiveness of Individual Education Plans for Children With Chronic Illness
Neurodevelopmental outcomes in children treated for cancer involving the central nervous
system (CNS) provide educators with new challenges with regards to classification,
monitoring, and intervention in the regular or special education classroom setting.
Recommendations resulting from serial neurodevelopmental evaluations for these children
often do not overlap with traditional special education recommendations commonly included in
Individual Education Plans (IEPs) for children with congenital or genetic learning problems.
The investigators currently do not know whether or not school-based treatment for learning
problems, based on the child's IEP, incorporates recommendations made based on a
neurodevelopmental evaluation appropriately. In addition, it is not clear whether or not the
recommendations that are included in a child's IEP have any beneficial outcome on the
child's learning and academic achievement over time. The purpose of this project is to
examine the relationship between neurodevelopmental outcomes, recommendations for
intervention, special education services and accommodations included in a child's school
IEP, and outcome for the child following implementation of the IEP. The study has two major
specific aims:
1. To quantify the clinical and educational contributions of recommendations resulting
from neurodevelopmental evaluations and the subsequent development of IEPs.
Hypothesis 1.1: Higher concordance between recommendations made based on
neurodevelopmental evaluations and criteria written into children's IEPs will be
associated with more positive academic outcomes (i.e. maintenance or improvement in
academic skills).
Hypothesis 1.2: Children who have higher concordance between criteria written into
their IEPs and academic services actually received will show more positive academic
outcomes than children whose IEP criteria and academic services are less concordant.
2. To evaluate an intervention that will improve academic outcomes for children treated
for cancer.
Hypothesis 2.1: Children whose IEPs are monitored more frequently will show more positive
academic outcomes than their peers whose IEPs are monitored less frequently.
For years, researchers have examined the effects of cancer and its treatment on children's
neurodevelopment. This body of research has identified a number of specific threats to
children's cognitive functioning and academic achievement, due to both acute effects and
late effects of cancer and its treatment. These often translate into difficulties in the
academic setting. Specifically, areas of cognitive and behavioral development are frequently
affected, leading to concomitant difficulties in academic achievement and social
interaction. Previous research has indicated that such developmental effects and concomitant
difficulties are particularly notable in children treated for brain tumors and for leukemias
with central nervous system (CNS) involvement. Neurodevelopmental assessments conducted as
part of clinical evaluations serve to identify individual strengths and weaknesses of each
child treated. Results of these assessments are used to formulate recommendations targeted
at compensating for weaknesses by accentuating strengths of each child. Child Study Team
meetings are scheduled, at the parent's request, at the child's school in order to use these
recommendations in developing Individual Educational Plans (IEPs) to best meet the special
needs of the student. At present, no formal follow-up procedure exists to ensure that the
IEPs are implemented appropriately, nor that they are effective in meeting the identified
special needs of the children.
The present study proposes to 1) evaluate the IEP implementation process for children with
cancer, 2) evaluate the effectiveness of IEPs in helping to improve academic outcomes for
children with cancer, and 3) to evaluate the influence on academic outcomes of a
high-monitoring follow-up intervention for children with cancer. To address these
objectives, school-aged children with central nervous system tumors, acute lymphoblastic
leukemia, or lymphoma will be administered a neurodevelopmental assessment to measure any
specific educational needs they may have. The results of the neurodevelopmental assessment
are provided to the parent in a feedback session where any questions or concerns regarding
the evaluation can be addressed. At the time of the feedback session, parents are informed
of the IEP process and are requested to contact the school to request that a Child Study
Team Meeting take place. The study personnel offer to attend the meeting with the parent.
Results of the assessments will be used to help guide recommendations made for academic
placement and accommodations as per the school's guidelines.
Children with cancer will be assigned to either a quarterly follow-up or annual follow-up
group. For those children in the quarterly follow-up group, parents and primary teacher (the
primary teacher is identified by the parent/guardian as the teacher who has the most contact
with the child and/or knows the child best) will be asked to provide information at the end
of each grading period (4 times/year) regarding the child's performance, progress, and
adherence to the IEP developed. For children in the yearly follow-up group, this information
will only be collected at the end of each academic year. Children in the quarterly and
annual follow-up groups will be re-assessed annually for a total of 3 years to evaluate any
changes in neurodevelopmental functioning and academic achievement.
Children in the two experimental groups will be administered a neurodevelopmental
evaluation, and, in addition, will receive academic follow-up on either a quarterly or
annual basis, depending upon to which group they are randomized. Enrollment is on an ongoing
basis and each participant will be followed for 3 years after enrollment, receiving a
neurodevelopmental evaluation each year with a final endpoint evaluation at year 4 (a total
of 4 neurodevelopmental evaluations).
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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