Back to results

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

Primary Purpose

Cancer Survivor, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Educational Intervention

Quality-of-Life Assessment

Questionnaire Administration

About this trial

This is an interventional supportive care trial for Cancer Survivor

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

City of Hope Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (Spanish-adapted skills training)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

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

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.

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.

Full Information

NCT ID

NCT02559557

First Posted

September 23, 2015

Last Updated

August 10, 2021

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02559557

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

October 22, 2015 (undefined)

Primary Completion Date

April 18, 2016 (Actual)

Study Completion Date

April 18, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Supportive care (Spanish-adapted skills training)

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Educational Intervention

Other Intervention Name(s)

Education for Intervention, Intervention, Educational

Intervention Description

Participate in focus groups

Intervention Type

Other

Intervention Name(s)

Educational Intervention

Other Intervention Name(s)

Education for Intervention, Intervention, Educational

Intervention Description

Undergo Spanish-adapted skills training and homework assignments

Intervention Type

Other

Intervention Name(s)

Quality-of-Life Assessment

Other Intervention Name(s)

Quality of Life Assessment

Intervention Description

Answer questionnaires

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Answer questionnaires

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

After 6 sessions (up to 12 months)

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

Baseline to up to 12 months

Title

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

Description

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

Time Frame

Baseline to up to 12 months

Title

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

Description

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

Time Frame

Baseline to up to 12 months

Title

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

Description

Time Frame

Up to 12 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sunita Patel

Organizational Affiliation

City of Hope Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

City of Hope Medical Center

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

12. IPD Sharing Statement

Learn more about this trial

We'll reach out to this number within 24 hrs