Family Functioning and Child Behavior When a Sibling is Critically Ill

Child Behavior Clinical Trial

Official title:

Family Functioning and Child Behavior When a Sibling is Critically Ill

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00912626
• Other study ID #: 2009-2-6426
• Status: Completed
• Phase: N/A
• First received: June 1, 2009
• Last updated: March 11, 2015
• Start date: June 2009
• Est. completion date: June 2014

Study information

• Verified date: April 2014
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Child Behavior
• Critical Illness

Intervention

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.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare behavioral assessment scores of siblings of children who are critically ill to scores of the general population		baseline and 6 months	No
Secondary	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.		baseline and 1 month	No