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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
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 1, 2009
Last Updated
March 11, 2015
Sponsor
Children's Hospital of Philadelphia
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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

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Family Functioning and Child Behavior When a Sibling is Critically Ill

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