Trial Information

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

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.