Improving Learning and School Functioning in Latino Children With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 214
- 试验地点
- 3
- 主要终点
- Change in child's health-related quality of life school functioning
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Educational Intervention (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Educational Intervention (Other)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in child's health-related quality of life school functioning
时间窗: Baseline up to 12 months
Measured by the parent-reported Pediatric Quality of Life Inventory school domain.
Change in parental efficacy
时间窗: Baseline up to 12 months
Measured by the Efficacy scale from the Parent Knowledge, Beliefs and Behaviors Questionnaire-3rd Revision (PBQ-R3).
次要结局
- Objective academic performance (Child)(Up to 12 months)
- Children's scores on other neurocognitive tests as assessed by learning, memory, and processing speed(Up to 12 months)
- Attention performance (Child)(Up to 12 months)
- Knowledge of pro-learning parenting (Parent)(Up to 12 months)
- Parental reports of their children's HRQOL as measured by the PedsQL parent proxy questionnaire(Up to 12 months)
- Frequency of pro-learning behaviors (Parent)(Up to 12 months)