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Active, Not Recruiting

NCT Number: NCT03178617

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center, Duarte, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Attend standard of care LIP

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Change in child's health-related quality of life school functioning

    Time frame: Baseline up to 12 months

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

  2. Change in parental efficacy

    Time frame: Baseline up to 12 months

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

Secondary outcomes

  1. Objective academic performance (Child)

    Time frame: Up to 12 months

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

  2. Attention performance (Child)

    Time frame: Up to 12 months

    Measured by the Conners Parent Report Attention subscale.

  3. Frequency of pro-learning behaviors (Parent)

    Time frame: Up to 12 months

    Measured by PBQ-R3 Behaviors Scale.

  4. Frequency of pro-learning behaviors (Parent)

    Time frame: Up to 12 months

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

  5. Knowledge of pro-learning parenting (Parent)

    Time frame: Up to 12 months

    Measured by PBQ-R3 Knowledge scale.

  6. Children's scores on other neurocognitive tests as assessed by learning, memory, and processing speed

    Time frame: Up to 12 months

  7. Parental reports of their children's HRQOL as measured by the PedsQL parent proxy questionnaire

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Improving Learning and School Functioning in Latino Children With Cancer

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Jun 7, 2017
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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