Culturally Adapted Parenting Intervention for Spanish-Speaking Parents in Improving Outcomes of Younger Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia Survivors at Risk for Late Neurocognitive Effects

Adaptation and Pilot-Testing a Parenting Intervention for Spanish-Speaking Parents of Children at Risk for Neurocognitive Late Effects

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.

Study Overview

• Status: Completed
• Conditions: Childhood Acute Myeloid Leukemia in Remission; Cancer Survivor; Childhood Acute Lymphoblastic Leukemia in Remission; Cognitive Side Effects of Cancer Therapy
• Intervention / Treatment: Other: Educational Intervention; Other: Educational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

INCLUSION CRITERIA FOR FOCUS GROUPS (PHASE I)

• Parents or adult primary caregiver (e.g., grandmother) of children ages 5 to 17 in treatment remission and has completed intensive therapy for ALL or AML
• Parents of childhood cancer survivors who are now 18 years or older and who were previously treated for ALL or AML (do not need to live with the child)
• One or both of the parents will self-identify as Hispanic/Latino, the primary participating parent will be either Spanish speaking, bilingual, or is bilingual but identifies their primary language as English and will live with the child

INCLUSION CRITERIA FOR PILOT-TESTING (PHASE II)

• Parent/Caregiver: parents or adult primary caregiver (e.g., grandmother) of children treated for ALL or AML
• Parent/Caregiver: one or both of the parents will self-identify as Hispanic/Latino, the primary participating parent will be either Spanish speaking, bilingual, or is bilingual but identifies their primary language as English and will live with the child
• Child: child is in treatment remission and has completed intensive therapy
• Child: child is age 5 to 17 years, 11 months
• Child: child understands English

Exclusion Criteria:

EXCLUSION CRITERIA FOR FOCUS GROUPS (PHASE I)

• Parents of ALL or AML survivors with a history of a major psychiatric condition that precludes participation (e.g., psychosis, severe depression, active substance abuse)
• Existing history of severe cognitive impairment in the child as reported by the parents or documented in the child's City of Hope medical records

EXCLUSION CRITERIA FOR PILOT TESTING (PHASE II)

• Parent/Caregiver: parents with a history of a major psychiatric condition that precludes participation (e.g., psychosis, severe depression, active substance abuse)
• Child: survivors with a history of a major psychiatric condition that precludes participation (e.g., psychosis, severe depression, active substance abuse)
• Child: existing history of severe cognitive impairment (intelligence quotient [IQ] =< 70) as reported by the parents or the child's City of Hope medical records, or by the child's performance score on the Wechsler Intelligence Scale for Children (WISC) Working Memory and Processing Speed index measures administered in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Supportive care (Spanish-adapted skills training); 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.

Other: Educational Intervention; Participate in focus groups; Other Names: Education for Intervention; Intervention, Educational; Other: Educational Intervention; Undergo Spanish-adapted skills training and homework assignments; Other Names: Education for Intervention; Intervention, Educational; Other: Quality-of-Life Assessment; Answer questionnaires; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Answer questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility, measured by the percentage of parents who complete the entire adapted skills-training parenting intervention	Feasibility will be operationally defined as > 75% of parents completing the intervention.	After 6 sessions (up to 12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in child's school-related health-related quality of life (HRQOL) score as assessed by the Pediatric Quality of Life scale	Explored for pre- and post-intervention changes using descriptive analyses.	Baseline to up to 12 months
Change in learning strategies as measured by the School Motivation and Learning Strategies Inventory	Explored for pre- and post-intervention changes using descriptive analyses.	Baseline to up to 12 months
Change in parent knowledge and efficacy, as measured by the Parent Knowledge, Beliefs, and Behaviors Questionnaire (PBQ)	Explored for pre- and post-intervention changes using descriptive analyses.	Baseline to up to 12 months
Parent satisfaction with the intervention as measured by the perceived benefits scale	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.	Up to 12 months

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: October 22, 2015
• Primary Completion (ACTUAL): April 18, 2016
• Study Completion (ACTUAL): April 18, 2016

Study Registration Dates

• First Submitted: September 23, 2015
• First Submitted That Met QC Criteria: September 23, 2015
• First Posted (ESTIMATE): September 24, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
• Other Study ID Numbers: 15297 (OTHER: City of Hope Medical Center); NCI-2015-01567 (REGISTRY: CTRP (Clinical Trial Reporting Program))