City of Hope Medical Center
Duarte, California, 91010, United States
NCT Number: NCT02559557
This pilot clinical trial studies a culturally adapted skills training and educational intervention in guiding parents of younger acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML) survivors at risk for long-term attention and memory problems (late neurocognitive effects). ALL and AML treatments target the central nervous system and may put younger survivors at increased risk for late neurocognitive effects, which may lead to learning difficulties or behavior problems and poor health-related quality of life. Spanish-speaking parents of young ALL or AML survivors may not have access to the information, resources, or guidance to help their children through these difficulties. Adapting an existing parent-training program into Spanish may help teach Spanish-speaking parents effective ways to prevent or reduce learning and behavioral difficulties, which may improve the quality of life of parents and young ALL or AML survivors.
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Interventional
Not applicable
Duarte, California, 91010, United States
PRIMARY OBJECTIVES:
I. To culturally modify and adapt an existing educational and skills-training intervention for use with Spanish-speaking parents of children with acute lymphoblastic leukemia (ALL) or with acute myeloid leukemia (AML).
II. To pilot the culturally-modified, parenting intervention with eligible families of children treated for ALL or AML in the Pediatrics department at City of Hope.
OUTLINE:
PHASE I (FOCUS GROUPS): Parents undergo a semi-structured interview with bilingual research assistants over 120 minutes. The content and purpose of the intervention is explained, and the focus group discussions elicit feedback on the intervention components and content of the sessions, and whether the material is culturally and linguistically appropriate. Following the focus group discussion, parents receive a copy of the educational handouts that they may choose to use with their child if they like.
PHASE II (PILOT TESTING): Parents of children age 5 to 17 years, 11 months old undergo adapted skills training in Spanish over 60 minutes (8 training sessions total) or 80 minutes (6 training sessions total). The adapted skills training sessions focus on parenting strategies and learning techniques. Sessions include homework assignments and techniques for parents to apply with their child for at least 30 minutes, 3 times a week at home.
After completion of study, parents are followed up every 2 weeks for 3 months and at 6 and 12 months.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
FOR FOCUS GROUPS (PHASE I)
Inclusion criteria
FOR PILOT-TESTING (PHASE II)
Exclusion criteria
Exclusion criteria
FOR FOCUS GROUPS (PHASE I)
Exclusion criteria
FOR PILOT TESTING (PHASE II)
Participate in focus groups
Other names: Education for Intervention, Intervention, Educational
Answer questionnaires
Other names: Quality of Life Assessment
Answer questionnaires
Time frame: After 6 sessions (up to 12 months)
Feasibility will be operationally defined as > 75% of parents completing the intervention.
Time frame: Baseline to up to 12 months
Explored for pre- and post-intervention changes using descriptive analyses.
Time frame: Baseline to up to 12 months
Explored for pre- and post-intervention changes using descriptive analyses.
Time frame: Baseline to up to 12 months
Explored for pre- and post-intervention changes using descriptive analyses.
Time frame: Up to 12 months
Satisfaction with intervention is defined as group mean rating of > 3/5 on the perceived benefit scale. Perceived benefit will be examined using group means obtained from parents' ratings on satisfaction and barriers questionnaires.
City of Hope Medical Center
Other
Adaptation and Pilot-Testing a Parenting Intervention for Spanish-Speaking Parents of Children at Risk for Neurocognitive Late Effects
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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