Lymphoma Clinical Trial
Official title:
Assessing Implementation and Effectiveness of Individual Education Plans for Children With Chronic Illness
Verified date | March 2012 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 62 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 12 Years |
Eligibility |
Inclusion Criteria: - Children, ages 6-12 years, who are within 2-5 years of diagnosis for either central nervous system tumor or acute lymphocytic leukemia, or lymphoma at time of enrollment Exclusion Criteria: - Children who have been diagnosed with any type of cancer other than a central nervous system tumor, lymphoma, or leukemia. - Children who are not between the ages of 6-12 years and who were not diagnosed within the past 2-5 years with central nervous system tumor, lymphoma, or leukemia. - Children who are monolingual in a language other than English or Spanish - Parent or caregiver of the child is not fluent in English or Spanish - Child has been diagnosed with a significant mental health disorder that is not responsive to behavioral or medical management. This includes severe depression, schizophrenia, or bipolar disorder. Children whose mental health problem is effectively treated are eligible for participation. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Mailman Center for Child Development University of Miami Miller School of Medicine | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami | American Cancer Society, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Academic achievement as measured by the Woodcock Johnson Tests of Achievement, Third Edition | Measured at Year 1, Year 2 and 3 | No |
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