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

Acute Myeloid Leukemia Clinical Trial

Official title:

Improving Learning and School Functioning in Latino Children With Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03178617
• Other study ID #: 17139
• Secondary ID: NCI-2017-0097117
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 14, 2018
• Est. completion date: December 15, 2024

Study information

• Verified date: December 2023
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 214
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Leukemia
• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Leukemia
• Lymphoblastic Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• Educational Intervention
Attend standard of care LIP
• Educational Intervention
Attend HIP
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Children's Hospital of Orange County	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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