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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma; Acute Leukemia
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Educational Intervention; Other: Educational 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.

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles
    • Orange, California, United States, 92868
      • Children's Hospital of Orange County

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (standard of care LIP); 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: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Educational Intervention; Attend standard of care LIP; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Educational Intervention; Attend HIP; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational
Experimental: Arm II (HIP); 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: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Educational Intervention; Attend standard of care LIP; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Educational Intervention; Attend HIP; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sunita Patel, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2017
• Primary Completion (Estimated): October 27, 2026
• Study Completion (Estimated): October 27, 2026

Study Registration Dates

• First Submitted: June 2, 2017
• First Submitted That Met QC Criteria: June 5, 2017
• First Posted (Actual): June 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Myeloid; Leukemia, Lymphoid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Investigative Techniques; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Methods; Early Intervention, Educational; Educational Status
• Other Study ID Numbers: 17139 (Other Identifier: City of Hope Medical Center); NCI-2017-00971 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); RSG-17-023-01-CPPB (Other Grant/Funding Number: ACS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No