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

NCT02559557 | Completed DMC

• 2 other identifiers: 15297NCI-2015-01567
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer Survivor; Childhood Acute Lymphoblastic Leukemia in Remission; Childhood Acute Myeloid Leukemia in Remission; Cognitive Side Effects of Cancer Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in child's school-related health-related quality of life (HRQOL) score as assessed by the Pediatric Quality of Life scale

  Baseline to up to 12 months

• Change in learning strategies as measured by the School Motivation and Learning Strategies Inventory

  Baseline to up to 12 months

• Change in parent knowledge and efficacy, as measured by the Parent Knowledge, Beliefs, and Behaviors Questionnaire (PBQ)

  Baseline to up to 12 months

• Parent satisfaction with the intervention as measured by the perceived benefits scale

  Up to 12 months

Study Arms (1)

Supportive care (Spanish-adapted skills training)

EXPERIMENTAL

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

Interventions

Educational Intervention OTHER

Participate in focus groups

Also known as: Education for Intervention, Intervention, Educational

Supportive care (Spanish-adapted skills training)

Quality-of-Life Assessment OTHER

Answer questionnaires

Also known as: Quality of Life Assessment

Supportive care (Spanish-adapted skills training)

Questionnaire Administration OTHER

Answer questionnaires

Supportive care (Spanish-adapted skills training)

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

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

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Interventions

Early Intervention, Educational; Educational Status; Methods

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: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: September 24, 2015
• Study Start: October 22, 2015
• Primary Completion: April 18, 2016
• Study Completion: April 18, 2016
• Last Updated: August 12, 2021

Record last verified: 2021-08

Locations

US (1)