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Completed

NCT Number: NCT02559557

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

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Participate in focus groups

Other names: Education for Intervention, Intervention, Educational

Quality-of-Life Assessment

Other

Answer questionnaires

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Answer questionnaires

Primary outcomes

  1. Feasibility, measured by the percentage of parents who complete the entire adapted skills-training parenting intervention

    Time frame: After 6 sessions (up to 12 months)

    Feasibility will be operationally defined as > 75% of parents completing the intervention.

Secondary outcomes

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

    Time frame: Baseline to up to 12 months

    Explored for pre- and post-intervention changes using descriptive analyses.

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

    Time frame: Baseline to up to 12 months

    Explored for pre- and post-intervention changes using descriptive analyses.

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

    Time frame: Baseline to up to 12 months

    Explored for pre- and post-intervention changes using descriptive analyses.

  4. Parent satisfaction with the intervention as measured by the perceived benefits scale

    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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 24, 2015
Registry last updated
Aug 12, 2021

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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