Ignite Creation Date:
2024-05-06 @ 12:58 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01704885
Status:
TERMINATED
Last Update Posted:
2015-08-03
First Post:
2012-10-09
Brief Title:
A Cognitive- Behavioral Play Intervention for Siblings of Children Diagnosed With Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Cognitive- Behavioral Play Intervention for Siblings of Children Diagnosed With Cancer A Pilot Study
Status:
TERMINATED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childs adjustment will be mediated by factors related to their involvement in the siblings medical care such as parents level of communication regarding their siblings illness frequent isolation from the family and other social support time since their siblings 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 groupChildren 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 eg How much did you like being a part of this study
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 childs adjustment will be mediated by factors related to their involvement in the siblings medical care such as parents level of communication regarding their siblings illness frequent isolation from the family and other social support time since their siblings 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 groupChildren 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 eg How much did you like being a part of this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CC00130 | OTHER | University Hospitals Cancer IRB | None |