Clinical trial NCT03178617: High-Intensity Parent Intervention Program in Improving Learning and School Functioning in Latino Children With Acute Leukemia or Lymphoblastic Lymphoma
Official title: Improving Learning and School Functioning in Latino Children With Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Lymphoblastic Lymphoma
Acute Leukemia
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-06-07
Enrollment: 214
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in child's health-related quality of life school functioning
timeFrame: Baseline up to 12 months
measure: Change in parental efficacy
timeFrame: Baseline up to 12 months
Secondary outcomes:
measure: Objective academic performance (Child)
timeFrame: Up to 12 months
measure: Attention performance (Child)
timeFrame: Up to 12 months
measure: Frequency of pro-learning behaviors (Parent)
timeFrame: Up to 12 months
measure: Frequency of pro-learning behaviors (Parent)
timeFrame: Up to 12 months
measure: Knowledge of pro-learning parenting (Parent)
timeFrame: Up to 12 months
measure: Children's scores on other neurocognitive tests as assessed by learning, memory, and processing speed
timeFrame: Up to 12 months
measure: Parental reports of their children's HRQOL as measured by the PedsQL parent proxy questionnaire
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Sunita Patel
role: PRINCIPAL_INVESTIGATOR
References: