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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving Learning and School Functioning in Latino Children With Cancer

Conditions
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Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Lymphoblastic Lymphoma, Acute Leukemia

Intervention / Treatment
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* Other: Educational Intervention
* Other: Educational Intervention
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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 10 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

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (standard of care LIP)<br>Parents or caregivers attend standard of care 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. | Other: Educational Intervention<br>* Attend standard of care LIP<br>* Other names: Intervention, Educational;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (HIP)<br>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. | Other: Educational Intervention<br>* Attend HIP<br>* Other names: Intervention, Educational;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in child's health-related quality of life school functioning | Measured by the parent-reported Pediatric Quality of Life Inventory school domain. | Baseline up to 12 months | 
| Change in parental efficacy | Measured by the Efficacy scale from the Parent Knowledge, Beliefs and Behaviors Questionnaire-3rd Revision (PBQ-R3). | Baseline up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective academic performance (Child) | Measured by WIAT: reading and math scores and classroom grades from school report cards. | Up to 12 months | 
| Attention performance (Child) | Measured by the Conners Parent Report Attention subscale. | Up to 12 months | 
| Frequency of pro-learning behaviors (Parent) | Measured by PBQ-R3 Behaviors Scale. | Up to 12 months | 
| Frequency of pro-learning behaviors (Parent) | Measured by the Parents' weekly time spent with child in pro-learning behaviors and activities. | Up to 12 months | 
| Knowledge of pro-learning parenting (Parent) | Measured by PBQ-R3 Knowledge scale. | Up to 12 months | 
| Children's scores on other neurocognitive tests as assessed by learning, memory, and processing speed |  | Up to 12 months | 
| Parental reports of their children's HRQOL as measured by the PedsQL parent proxy questionnaire |  | Up to 12 months |