Family Functioning and Child Behavior When a Sibling is Critically Ill

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00912626
First received: June 1, 2009
Last updated: July 25, 2013
Last verified: July 2013
  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: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00912626     History of Changes
Other Study ID Numbers: 2009-2-6426
Study First Received: June 1, 2009
Last Updated: July 25, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014