A Cognitive- Behavioral Play Intervention for Siblings of Children Diagnosed With Cancer
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|ClinicalTrials.gov Identifier: NCT01704885|
Recruitment Status : Terminated (Slow Accrual)
First Posted : October 12, 2012
Last Update Posted : August 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Any Cancer Diagnosis||Behavioral: Play Intervention Other: Questionnaires||Early Phase 1|
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?").
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
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
- 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.
- 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.
- 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.
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
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Karla Fehr, M.A.||Case Western Reserve University|