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: April 21, 2014
Last verified: April 2014
  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

Resource links provided by NLM:


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 2014
Estimated Primary Completion Date: November 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 21, 2014
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 September 22, 2014