Clinical Trials Directory

Trials / Terminated

TerminatedNCT01704885

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

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

Status
Terminated
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
5 (actual)
Sponsor
Case Comprehensive Cancer Center · Academic / Other
Sex
All
Age
4 Years – 10 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALPlay Intervention
OTHERQuestionnaires

Timeline

Start date
2011-09-01
Primary completion
2015-07-01
Completion
2015-07-01
First posted
2012-10-12
Last updated
2015-08-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01704885. Inclusion in this directory is not an endorsement.