Educational and Skills Training Program for Parents of Childhood Cancer Survivors Who Have Neurobehavioral Dysfunction

Lymphoma Clinical Trial

Official title:

A Behavioral Intervention Trial for Parents of Childhood Cancer Survivors With Neurobehavioral Late Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713505
• Other study ID #: CDR0000598114
• Secondary ID: R03CA130731P30CA
• Status: Completed
• Phase: N/A
• First received: July 10, 2008
• Last updated: October 11, 2010
• Start date: May 2008
• Est. completion date: March 2010

Study information

• Verified date: October 2010
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

RATIONALE: An educational and skills training program for the parent of a childhood cancer survivor with neurobehavioral dysfunction may help improve the child's school performance, thinking ability, and behavior.

PURPOSE: This randomized clinical trial is studying an educational and skills training program for parents of childhood cancer survivors who have neurobehavioral dysfunction.

Description:

OBJECTIVES:

• To determine the feasibility of implementing an educational and skills training intervention for parents of a childhood cancer survivor with neurobehavioral dysfunction using face-to-face training sessions and phone assistance.

• To pilot test and collect preliminarily data on the indirect therapeutic impact of the parent training intervention on the child's academic, cognitive, and behavioral functioning.

• To pilot test and collect preliminary outcomes of the parent training intervention on parents of a childhood cancer survivor with neurobehavioral dysfunction.

OUTLINE: Parent and child participants are randomized to 1 of 2 intervention arms.

• Arm I (parent intervention program and usual care): In addition to medical care, child participants and their families may access multidisciplinary psychosocial services (i.e., usual care). Parents also receive 8 weekly face-to-face training sessions (75-90 minutes each) with a therapist over approximately 2-3 months. The training sessions include integration and didactic review of a parent's role as a behavioral and emotional support system for the child's school success; a parent's role as a monitor and motivator for school performance; a parent's role as an intervener and teacher of effective learning and study strategies; and a parent's role as a child advocate and accessor of educational and community resources. Parents are instructed to engage in ≥ 30 minutes of cognitive and academic activities with their child ≥ 4 days a week. The therapist will observe the parent (in the home or clinic) apply knowledge and techniques learned in the parent training sessions directly with the child at least once after the 4th parent-therapist session to provide feedback to the parent and child and to assess which parents may require more intense training and support. The sessions may be videotaped by the parent and provided to the therapist for review and follow up.

Phone support/assistance is provided by the therapist within 2-3 days following each training session to provide additional problem-solving assistance and teaching support to the parents while they are implementing the knowledge and strategies learned during the training sessions and to measure study adherence and behavioral implementation between the sessions. After completion of the training sessions, continued phone support/assistance is provided by the therapist every 2 weeks for up to 6 months to provide ongoing support and problem-solving and teaching assistance as needed and to promote ongoing maintenance of the trained parenting practices with a greater degree of independence. "Booster" in-person sessions may also occur if determined to be needed by both the therapist and parent.

• Arm II (wait-list/usual care control [UCC]): Child participants and their families undergo usual care as in arm I and are placed on a wait-list.

Parent and child participants in both arms complete battery testing and questionnaires at baseline, 3 months, and 6 months. Battery testing includes the Wechsler Individual Achievement Test (WIAT-II) and the WISC-IV Working Memory Index and Children's Memory Scale (CMS) subtests. Questionnaires include parent, teacher, and child [self-report] questionnaires (BASC-II, BRIEF, and SMALSI); Parent Behaviors Questionnaire-Revised; Parent Knowledge and Efficacy Questionnaire; and Parent's Treatment Barriers and Satisfaction Questionnaire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

DISEASE CHARACTERISTICS:

• Childhood cancer survivor who received CNS-directed therapy (i.e., intrathecal chemotherapy and/or cranial radiotherapy) for leukemia or non-Hodgkin lymphoma

• In remission AND completed treatment = 3 months ago

• No brain tumors

• Enrolled in school and demonstrates a deficit (operationalized as at least one standard deviation below the age expected mean) on at least one objective test of attention or memory on baseline cognitive assessment screening AND has evidence of problems in learning and adaptive functioning

• Parent, teacher, or self-report of problems as measured by a T-score of = 60 on the BRIEF or BASC or below average academic achievement scores

• Able to be tested in English using standardized cognitive and academic achievement tools

PATIENT CHARACTERISTICS:

• Primary participating parent or caregiver fluent in English and lives with the child

• No known history of a major psychiatric condition (i.e., psychosis) that precludes study participation (child or participating parent or caregiver)

• No history of child developmental disability prior to cancer diagnosis

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Design

Allocation: Randomized

Related Conditions & MeSH terms

• Cancer Survivor
• Cognitive/Functional Effects
• Leukemia
• Long-term Effects Secondary to Cancer Therapy in Children
• Lymphoma
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Other:
• educational intervention
Parents receive face-to-face training sessions with a therapist over approximately 2-3 months. Phone support/assistance is provided by the therapist within 2-3 days following each training session and then every 2 weeks for up to 6 months after completion of the training sessions.

Procedure:
• psychosocial assessment and care
Child participants and their families may access multidisciplinary psychosocial services (i.e., usual care).

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WIAT-II-Reading, Mathematics, and Writing composite scores as measured at baseline and 6 months (child participant)			No
Primary	Knowledge, efficacy, and self-report of pro-learning behaviors as measured by the PKEQ and PBQ-R at baseline, 3 months, and 6 months (parent participant)			No
Secondary	Parent, teacher, and self-report measures as measured by the BRIEF, BASC-II, and SMALSI at baseline, 3 months, and 6 months (child participant)			No
Secondary	Performance on attention and memory tests as measured by the CMS and WISC-IV subtests at baseline and 6 months (child participant)			No
Secondary	Parenting stress as measured by the PSI at baseline, 3 months, and 6 months (parent participant)			No