Family Functioning and Child Behavior When a Sibling is Critically Ill
Primary Purpose
Child Behavior
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
One week follow up assessment results
Sponsored by
About this trial
This is an interventional basic science trial for Child Behavior focused on measuring siblings, family, child behavior, critical illness, social support
Eligibility Criteria
Inclusion Criteria:
- adult (age 18 and older) who has decision making authority for CHOP patient who has been referred to the Pediatric Advanced Care Team (PACT) for palliative care services, and with a child(ren) age 6-11 years who is a sibling of the patient
- any race/ethnicity
Exclusion Criteria:
- Non-English speaking
Sites / Locations
- The Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
FU-1 feedback
control group
Arm Description
Outcomes
Primary Outcome Measures
To compare behavioral assessment scores of siblings of children who are critically ill to scores of the general population
Secondary Outcome Measures
To assess if parents who receive results of sibling behavior scores and a brief intervention, compared to parents who do not receive this information or intervention, have a different perception of the sibling's strengths and difficulties.
Full Information
NCT ID
NCT00912626
First Posted
June 1, 2009
Last Updated
March 11, 2015
Sponsor
Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT00912626
Brief Title
Family Functioning and Child Behavior When a Sibling is Critically Ill
Official Title
Family Functioning and Child Behavior When a Sibling is Critically Ill
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to determine if there is a correlation between an efficacious family environment and sibling behavior in families with children who are critically ill.
Detailed Description
Families of critically ill children can face many emotional challenges during the course of a child's illness. While some research has looked at the impact on parents, there has been little focused on siblings. We want to better understand how social support may have a protective effect on siblings' quality of life. The goal of this study is to determine if there is a correlation between an efficacious family environment and sibling behavior in families with children who are critically ill. Our hypothesis is that a cohesive, emotionally rich and open family environment provides social support so that siblings can explore and express the difficult emotions that accompany illness, and is therefore a protective factor for a sibling's behavior.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Behavior
Keywords
siblings, family, child behavior, critical illness, social support
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FU-1 feedback
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
One week follow up assessment results
Intervention Description
FU-1 feedback group will receive child behavior assessment results and interpretation,and a brief intervention to encourage support options.
Primary Outcome Measure Information:
Title
To compare behavioral assessment scores of siblings of children who are critically ill to scores of the general population
Time Frame
baseline and 6 months
Secondary Outcome Measure Information:
Title
To assess if parents who receive results of sibling behavior scores and a brief intervention, compared to parents who do not receive this information or intervention, have a different perception of the sibling's strengths and difficulties.
Time Frame
baseline and 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult (age 18 and older) who has decision making authority for CHOP patient who has been referred to the Pediatric Advanced Care Team (PACT) for palliative care services, and with a child(ren) age 6-11 years who is a sibling of the patient
any race/ethnicity
Exclusion Criteria:
Non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Feudtner, MD, PhD, MPH
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Family Functioning and Child Behavior When a Sibling is Critically Ill
We'll reach out to this number within 24 hrs