High-Intensity Parent Intervention Program in Improving Learning and School Functioning in Latino Children With Acute Leukemia or Lymphoblastic Lymphoma



Status:Recruiting
Conditions:Other Indications, Blood Cancer, Blood Cancer, Lymphoma, Lymphoma, Hematology
Therapuetic Areas:Hematology, Oncology, Other
Healthy:No
Age Range:5 - Any
Updated:12/7/2018
Start Date:February 14, 2018
End Date:February 2021

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Improving Learning and School Functioning in Latino Children With Cancer

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.

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.

SECONDARY 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.

Inclusion Criteria:

- PARENT/CAREGIVER: Adult primary caregiver of children treated for leukemia or
lymphoblastic lymphoma (LL) and daily contact with the child

- PARENT/CAREGIVER: One or both parents self-identify as Hispanic/Latino and the primary
participating parent/caregiver is monolingual or bilingual Spanish speaking

- CHILD: Children treated for acute leukemia (e.g. acute lymphoblastic leukemia [ALL],
acute myeloid leukemia [AML]), LL, or other types of leukemia (if treated intensively)
aged 5-12 years and their parents/caregivers

- CHILD: Child has completed cancer treatment and is up to 7 years post-treatment

- CHILD: Child understands English and is enrolled in school (but can be bilingual)

Exclusion Criteria:

- History of major psychiatric condition (e.g. psychosis) in parent or child; severe
neurodevelopmental disorder in child (e.g. Down's syndrome)

- Recent or current participation in educational/behavioral intervention study with
similar focus
We found this trial at
3
sites
1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Principal Investigator: Van T. Huynh
Phone: 714-509-8481
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: David R. Freyer
Phone: 323-361-8953
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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Duarte, California 91010
Principal Investigator: Sunita K. Patel
Phone: 626-218-6062
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Duarte, CA
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