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| ID | Type | Description | Link |
|---|---|---|---|
| CC00130 | Other Identifier | University Hospitals Cancer IRB |
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Slow Accrual
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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.
Aim 1: Assess baseline adjustment, coping, pretend play, parenting stress, and family interactions.
Aim 2: Assess outcome of three play intervention sessions focusing on increasing coping and adjustment.
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?").
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Control Group | Sham Comparator | 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. |
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| Play Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Play Intervention | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of children with increase in coping skills after intervention | Compared to the active control, children in the play intervention group will have increased coping skills after intervention. | 4 weeks |
| Number of children with better psychological adjustment following intervention | Compared to the active control, children in the play intervention group will have better psychological adjustment following intervention. | 4 weeks |
| Number of parents with decreased parenting stress following intervention | Parents of children in the play intervention group will report decreased parenting stress following the intervention. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Karla Fehr, M.A. | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D010989 | Play Therapy |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
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| Questionnaires | Other |
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| D004191 |
| Behavioral Disciplines and Activities |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |