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Family Functioning and Child Behavior When a Sibling is Critically Ill

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00912626
First Posted: June 3, 2009
Last Update Posted: March 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
  Purpose
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.

Condition Intervention
Child Behavior Behavioral: One week follow up assessment results

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Family Functioning and Child Behavior When a Sibling is Critically Ill

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • 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 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. [ Time Frame: baseline and 1 month ]

Enrollment: 90
Study Start Date: June 2009
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FU-1 feedback Behavioral: One week follow up assessment results
FU-1 feedback group will receive child behavior assessment results and interpretation,and a brief intervention to encourage support options.
No Intervention: control group

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00912626


Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Chris Feudtner, MD, PhD, MPH Children's Hospital of Philadelphia
  More Information

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00912626     History of Changes
Other Study ID Numbers: 2009-2-6426
First Submitted: June 1, 2009
First Posted: June 3, 2009
Last Update Posted: March 12, 2015
Last Verified: April 2014

Keywords provided by Children's Hospital of Philadelphia:
siblings
family
child behavior
critical illness
social support

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes