High-Intensity Parent Intervention Program in Improving Learning and School Functioning in Latino Children With Acute Leukemia or Lymphoblastic Lymphoma
Primary Purpose
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Lymphoblastic Lymphoma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Educational Intervention
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Lymphoblastic Leukemia
Eligibility Criteria
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
Sites / Locations
- City of Hope Medical Center
- Children's Hospital Los Angeles
- Children's Hospital of Orange County
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm I (standard of care LIP)
Arm II (HIP)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in child's health-related quality of life school functioning
Measured by the parent-reported Pediatric Quality of Life Inventory school domain.
Change in parental efficacy
Measured by the Efficacy scale from the Parent Knowledge, Beliefs and Behaviors Questionnaire-3rd Revision (PBQ-R3).
Secondary Outcome Measures
Objective academic performance (Child)
Measured by WIAT: reading and math scores and classroom grades from school report cards.
Attention performance (Child)
Measured by the Conners Parent Report Attention subscale.
Frequency of pro-learning behaviors (Parent)
Measured by PBQ-R3 Behaviors Scale.
Frequency of pro-learning behaviors (Parent)
Measured by the Parents' weekly time spent with child in pro-learning behaviors and activities.
Knowledge of pro-learning parenting (Parent)
Measured by PBQ-R3 Knowledge scale.
Children's scores on other neurocognitive tests as assessed by learning, memory, and processing speed
Parental reports of their children's HRQOL as measured by the PedsQL parent proxy questionnaire
Full Information
NCT ID
NCT03178617
First Posted
June 2, 2017
Last Updated
September 7, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03178617
Brief Title
High-Intensity Parent Intervention Program in Improving Learning and School Functioning in Latino Children With Acute Leukemia or Lymphoblastic Lymphoma
Official Title
Improving Learning and School Functioning in Latino Children With Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 14, 2018 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Lymphoblastic Lymphoma, Acute Leukemia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
276 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I (standard of care LIP)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm II (HIP)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Attend standard of care LIP
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Attend HIP
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in child's health-related quality of life school functioning
Description
Measured by the parent-reported Pediatric Quality of Life Inventory school domain.
Time Frame
Baseline up to 12 months
Title
Change in parental efficacy
Description
Measured by the Efficacy scale from the Parent Knowledge, Beliefs and Behaviors Questionnaire-3rd Revision (PBQ-R3).
Time Frame
Baseline up to 12 months
Secondary Outcome Measure Information:
Title
Objective academic performance (Child)
Description
Measured by WIAT: reading and math scores and classroom grades from school report cards.
Time Frame
Up to 12 months
Title
Attention performance (Child)
Description
Measured by the Conners Parent Report Attention subscale.
Time Frame
Up to 12 months
Title
Frequency of pro-learning behaviors (Parent)
Description
Measured by PBQ-R3 Behaviors Scale.
Time Frame
Up to 12 months
Title
Frequency of pro-learning behaviors (Parent)
Description
Measured by the Parents' weekly time spent with child in pro-learning behaviors and activities.
Time Frame
Up to 12 months
Title
Knowledge of pro-learning parenting (Parent)
Description
Measured by PBQ-R3 Knowledge scale.
Time Frame
Up to 12 months
Title
Children's scores on other neurocognitive tests as assessed by learning, memory, and processing speed
Time Frame
Up to 12 months
Title
Parental reports of their children's HRQOL as measured by the PedsQL parent proxy questionnaire
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunita Patel
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
12. IPD Sharing Statement
Learn more about this trial
High-Intensity Parent Intervention Program in Improving Learning and School Functioning in Latino Children With Acute Leukemia or Lymphoblastic Lymphoma
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