Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01704885
Recruitment Status : Terminated (Slow Accrual)
First Posted : October 12, 2012
Last Update Posted : August 3, 2015
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Any Cancer Diagnosis Behavioral: Play Intervention Other: Questionnaires Early Phase 1

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?").


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Cognitive- Behavioral Play Intervention for Siblings of Children Diagnosed With Cancer: A Pilot Study
Study Start Date : September 2011
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Arm Intervention/treatment
Sham Comparator: 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.
Other: Questionnaires
Other Names:
  • 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

Experimental: 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.
Behavioral: Play Intervention
Other Names:
  • Story Stems to play out
  • Problem solving
  • positive self-statements
  • make up a story

Other: Questionnaires
Other Names:
  • 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




Primary Outcome Measures :
  1. Number of children with increase in coping skills after intervention [ Time Frame: 4 weeks ]
    Compared to the active control, children in the play intervention group will have increased coping skills after intervention.

  2. Number of children with better psychological adjustment following intervention [ Time Frame: 4 weeks ]
    Compared to the active control, children in the play intervention group will have better psychological adjustment following intervention.

  3. Number of parents with decreased parenting stress following intervention [ Time Frame: 4 weeks ]
    Parents of children in the play intervention group will report decreased parenting stress following the intervention.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704885


Locations
Layout table for location information
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Karla Fehr, M.A. Case Western Reserve University

Layout table for additonal information
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01704885     History of Changes
Other Study ID Numbers: CASE4Z11
CC00130 ( Other Identifier: University Hospitals Cancer IRB )
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: August 3, 2015
Last Verified: July 2015
Keywords provided by Case Comprehensive Cancer Center:
Childhood Cancer
Sibling Play intervention
Sibling Behavioral Intervention
Siblings of Cancer Patients