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

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What is being tested

Educational Intervention

+ Educational Intervention
+ Quality-of-Life Assessment
Other
Who is being recruted

Acute Lymphoblastic Leukemia
+1

+ Acute Myeloid Leukemia
+ Lymphoblastic Lymphoma
Over 5 Years
+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Interventional
Study Start: February 2018

See protocol details

Summary

Principal SponsorCity of Hope Medical Center
Last updated: July 4, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: February 14, 2018Actual date on which the first participant was enrolled.

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. 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 TitleImproving Learning and School Functioning in Latino Children With Cancer 
Principal SponsorCity of Hope Medical Center
Last updated: July 4, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
214 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 5 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Lymphoblastic Lymphoma
Acute Leukemia
Criteria
5 inclusion criteria required to participate
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

Show More Criteria

2 exclusion criteria prevent from participating
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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Active Comparator
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.
Group II
Experimental
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.
Study Objectives
Primary Objectives

Measured by the parent-reported Pediatric Quality of Life Inventory school domain.

Measured by the Efficacy scale from the Parent Knowledge, Beliefs and Behaviors Questionnaire-3rd Revision (PBQ-R3).
Secondary Objectives

Measured by WIAT: reading and math scores and classroom grades from school report cards.

Measured by the Conners Parent Report Attention subscale.

Measured by PBQ-R3 Behaviors Scale.

Measured by the Parents' weekly time spent with child in pro-learning behaviors and activities.

Measured by PBQ-R3 Knowledge scale.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 3 locations
Suspended
City of Hope Medical CenterDuarte, United StatesSee the location
Suspended
Children's Hospital Los AngelesLos Angeles, United States
Suspended
Children's Hospital of Orange CountyOrange, United States
Suspended3 Study Centers