- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00912626
Family Functioning and Child Behavior When a Sibling is Critically Ill
March 11, 2015 updated by: Children's Hospital of Philadelphia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- The Children's Hospital of Philadelphia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control group
|
|
Experimental: FU-1 feedback
|
FU-1 feedback group will receive child behavior assessment results and interpretation,and a brief intervention to encourage support options.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
baseline and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
baseline and 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chris Feudtner, MD, PhD, MPH, Children's Hospital of Philadelphia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
June 1, 2009
First Submitted That Met QC Criteria
June 1, 2009
First Posted (Estimate)
June 3, 2009
Study Record Updates
Last Update Posted (Estimate)
March 12, 2015
Last Update Submitted That Met QC Criteria
March 11, 2015
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-2-6426
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Child Behavior
-
University of New MexicoActive, not recruitingChild Abuse | Parenting | Child Behavior | Child Development | Delinquency | Criminal Behavior | Child NeglectUnited States
-
Children's Hospital of PhiladelphiaPNC FoundationTerminatedChild Behavior | Child Development | Child Behavior ProblemUnited States
-
University of Southern CaliforniaSafe Water and AIDS Project (SWAP); Early Childhood Development Network for...RecruitingChild Behavior | Child Development | Language, ChildKenya
-
Windward Islands Research and Education FoundationGrand Challenges Canada; St. George's University; GRENCASECompletedDevelopment, Child | Behavior, Child | Neurocognition, ChildGrenada
-
University of PittsburghThe Grable Foundation; The Shear Family Foundation; Heinz EndowmentsRecruitingParenting | Child Development | Child Behavior Problem | Parent Child Abuse | Child LanguageUnited States
-
Children's Hospital Los AngelesNational Institute on Minority Health and Health Disparities (NIMHD)Not yet recruitingChild Behavior | Child Behavior Problem | Child Behavior Disorders | Racism
-
International Centre for Diarrhoeal Disease Research...UnknownChild Behavior | Child DevelopmentBangladesh
-
University of South CarolinaCompletedParents | Child Behavior | Child Health | Child, PreschoolUnited States
-
University of FloridaNational Institute of Dental and Craniofacial Research (NIDCR)Not yet recruitingChild Behavior | Behavior and Behavior Mechanisms
-
University of California, BerkeleySave the Children; Health for a Prosperous Nation; Camara Education, Tanzania; Ubongo... and other collaboratorsCompletedBehavior, Child | Behavior, Adaptive | Behavior, SocialTanzania
Clinical Trials on One week follow up assessment results
-
University of LiegeRecruitingCritical Illness | Bone Loss | Kidney Injury | Muscle LossBelgium
-
Ohio State University Comprehensive Cancer CenterNot yet recruitingBreast Carcinoma | Breast Atypical Ductal Hyperplasia | Breast Atypical Lobular Hyperplasia | Breast Lobular Carcinoma In Situ | Breast Sclerosing AdenosisUnited States
-
Centre Hospitalier Universitaire de NiceCompleted
-
University Hospital, Basel, SwitzerlandCompletedClavicular LengthSwitzerland
-
City of Hope Medical CenterActive, not recruiting
-
Christopher ChanSunnybrook Health Sciences Centre; Baxter Healthcare Corporation; University... and other collaboratorsCompletedEnd Stage Renal Disease | Kidney Failure | Home DialysisCanada
-
University Hospital, Basel, SwitzerlandUniversity Hospital, Geneva; Medical University Innsbruck; Luzerner Kantonsspital and other collaboratorsRecruitingMyocardial Infarction | Myocardial Injury | Perioperative ComplicationSwitzerland, Austria
-
University of IowaCompletedPost Partum Depression | Perinatal Depression | Perinatal Anxiety | Post Partum AnxietyUnited States
-
King's College LondonBiotechnology and Biological Sciences Research Council; Biotherapy Services...RecruitingDiabetic Foot | Diabetic Foot UlcerUnited Kingdom
-
Hospital de Clinicas de Porto AlegreUnknownSpinocerebellar Ataxia Type 3 | Machado-Joseph Disease | SCA3 | MJDBrazil