Educational Intervention
OtherAttend standard of care LIP
Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
NCT Number: NCT03178617
This randomized clinical trial studies how well a high-intensity intervention parenting program works in improving learning and school functioning in Latino children with acute leukemia or lymphoblastic lymphoma. A high-intensity intervention program may help doctors to see whether training parents or caregivers in specific parenting skills and "pro-learning" behaviors will result in better learning and school outcomes for Latino children with acute leukemia or lymphoblastic lymphoma. It is not yet known if a high-intensity intervention program is more beneficial than a standard of care lower intensity parenting intervention.
This study is active but is not currently recruiting participants.
5 year and older
All sexes
Interventional
Not applicable
City of Hope Medical Center, Duarte, California, United States
PRIMARY OBJECTIVES:
I. Determine the effectiveness of an enhanced parenting intervention, high-intensity intervention program (HIP), on pediatric cancer survivors' learning and school health-related quality of life (HRQOL) outcomes up to 12 months post enrollment.
II. Determine the effectiveness of HIP on the "pro-learning" efficacy of parents of pediatric cancer survivors up to 12 months post enrollment.
III. Examine the extent to which the parent's increases in personal efficacy and use of "pro-learning" behaviors correlate with the child's school HRQOL and academic performance.
IV. Obtain preliminary data on the relationships between family stress and the Val66Met polymorphism of brain-derived neurotrophic factor (BDNF) with neurocognitive and health-related quality of life (HRQOL) outcomes in Latino children treated with CNS-directed therapies for cancer.
V. Conduct preliminary analysis on the interaction between family stress and the BDNF Met polymorphism when predicting cognitive and HRQOL outcomes in Latino children treated for cancer.
EXPLORATORY OBJECTIVES:
I. Explore the associations between neurocognitive performance and polymorphisms in candidate genes previously reported to explain cognitive variability in childhood cancer survivors (e.g., the catechol-O-methyltransferase Val158Met polymorphism and the nitric oxide synthase [NOS3] 894T allele) or involved in the stress response (e.g., the Serotonin transporter rs25531 and the Glucocorticoid receptor rs6190).
OUTLINE: Parents or caregivers are randomized to 1 of 2 arms.
ARM I: Parents or caregivers attend standard of care lower intensity intervention program (LIP) consisting of a meeting to review results of a neurocognitive evaluation and to discuss recommendations for optimal learning and school performance for 1 session.
ARM II: Parents or caregivers attend HIP consisting of individual parental skill training sessions with a bilingual therapist over 60-90 minutes every 2 weeks for a total of 8 sessions.
After study enrollment, patients are followed up for 12 months.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Attend standard of care LIP
Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Ancillary studies
Other names: Quality of Life Assessment
Ancillary studies
Time frame: Baseline up to 12 months
Measured by the parent-reported Pediatric Quality of Life Inventory school domain.
Time frame: Baseline up to 12 months
Measured by the Efficacy scale from the Parent Knowledge, Beliefs and Behaviors Questionnaire-3rd Revision (PBQ-R3).
Time frame: Up to 12 months
Measured by WIAT: reading and math scores and classroom grades from school report cards.
Time frame: Up to 12 months
Measured by the Conners Parent Report Attention subscale.
Time frame: Up to 12 months
Measured by PBQ-R3 Behaviors Scale.
Time frame: Up to 12 months
Measured by the Parents' weekly time spent with child in pro-learning behaviors and activities.
Time frame: Up to 12 months
Measured by PBQ-R3 Knowledge scale.
Time frame: Up to 12 months
Time frame: Up to 12 months
City of Hope Medical Center
Other
Improving Learning and School Functioning in Latino Children With Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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