A Cognitive- Behavioral Play Intervention for Siblings of Children Diagnosed With Cancer

NCT ID: NCT01704885

Last Updated: 2015-08-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-07-31

Brief Summary

The goal of this study is to determine whether a brief (three 20-30 minute session) cognitive-behavioral play intervention will improve coping skills and adjustment for siblings of children diagnosed with cancer.

Detailed Description

Aim 1: Assess baseline adjustment, coping, pretend play, parenting stress, and family interactions.

• Hypothesis 1a: Children with siblings diagnosed with cancer will have lower levels of adjustment, coping skills, and pretend play compared to previous sample norms.
• Hypothesis 1b: The child's adjustment will be mediated by factors related to their involvement in the sibling's medical care, such as parent's level of communication regarding their sibling's illness, frequent isolation from the family and other social support, time since their sibling's diagnosis, and parenting stress. -Hypothesis 1c: Parents of children diagnosed with cancer will report higher levels of parenting stress compared to previous sample norms.

Aim 2: Assess outcome of three play intervention sessions focusing on increasing coping and adjustment.

• Hypothesis 2a: Compared to the active control, children in the play intervention group will have increased coping skills after intervention.
• Hypothesis 2b: Compared to the active control, children in the play intervention group will have better psychological adjustment following intervention.
• Hypothesis 2c: Parents of children in the play intervention group will report decreased parenting stress following the intervention.

Once parents consent to participate and their child provides assent, they and their child will complete the baseline questionnaires and measures. Immediately following completion of the baseline measures, the child will be randomly assigned to either the play intervention or active control group.Children will also be asked to rate their mood at the beginning of each play session. The outcome parent and child questionnaires will be administered again at a session approximately one week after the third play session, for a total of four play sessions each spaced approximately one week apart. Children will also be asked to rate their satisfaction with the treatment at the outcome session (e.g., "How much did you like being a part of this study?").

Conditions

Any Cancer Diagnosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Active Control Group

Children in the active control group will play with puzzles, a building toy, or color. The play facilitator will praise the child and interact at a similar rate to control for interaction with a caring adult.

Group Type: SHAM_COMPARATOR

Questionnaires

Intervention Type: OTHER

Play Intervention

children in the play intervention group will be given 3 story stems that they are asked to play out with the goal of helping the main character "feel better" (see session scripts). The play facilitator will play with the child, modeling and praising use of positive coping skills. In the first session the play facilitator will focus on positive self-statements, in the second session the play facilitator will focus on problem-solving, and a combination of these two approaches will be used in the final session. The child will be allowed to make up a story about whatever they want before ending each session.

Group Type: EXPERIMENTAL

Play Intervention

Intervention Type: BEHAVIORAL

Questionnaires

Intervention Type: OTHER

Interventions

Play Intervention

Intervention Type: BEHAVIORAL

Questionnaires

Intervention Type: OTHER

Other Intervention Names

Story Stems to play out; Problem solving; positive self-statements; make up a story; Demographic questionnaire; Parent/Well-Sibling Communication Measure; BASC-2 (Behavior Assessment System for Children-Second Edition); RSQ (Response to Stress Questionnaire); PSI-SF (Parenting Stress Index-Short Form); Mood Assessment; Perceived self-efficacy; ALTTIQ (Assessment of Life Threat and Treatment Intensity Questionnaire); APS (Affect in Play Scale) or APS-P; SPQ (Sibling Perception Questionnaire); Assessment of treatment satisfaction; Free play assessment

Eligibility Criteria

Inclusion Criteria

• Families who have had children diagnosed with any type of cancer in the past year.
• At least one sibling between the ages of 4 and 10 years old
• Patients will be targeted 1-2 months after diagnosis, but could be included in the study up to 12 months following diagnosis.

Exclusion Criteria

-

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karla Fehr, M.A.

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CC00130

Identifier Type: OTHER

Identifier Source: secondary_id

CASE4Z11

Identifier Type: -

Identifier Source: org_study_id