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

NCT03178617 | Active Not Recruiting DMC

• 3 other identifiers: 17139NCI-2017-00971RSG-17-023-01-CPPB
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Lymphoblastic Lymphoma; Acute Leukemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Objective academic performance (Child)

  Up to 12 months

• Attention performance (Child)

  Up to 12 months

• Frequency of pro-learning behaviors (Parent)

  Up to 12 months

• Frequency of pro-learning behaviors (Parent)

  Up to 12 months

• Knowledge of pro-learning parenting (Parent)

  Up to 12 months

Study Arms (2)

Arm I (standard of care LIP)

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.

Other: Educational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (HIP)

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.

Other: Educational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Educational Intervention OTHER

Attend standard of care LIP

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm I (standard of care LIP)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (standard of care LIP); Arm II (HIP)

Questionnaire Administration OTHER

Ancillary studies

Arm I (standard of care LIP); Arm II (HIP)

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute

Interventions

Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Sunita Patel

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 7, 2017
• Study Start: October 12, 2017
• Primary Completion (Estimated): October 27, 2026
• Study Completion (Estimated): October 27, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (3)