NCT00912626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 12, 2015

Status Verified

April 1, 2014

Enrollment Period

5 years

First QC Date

June 1, 2009

Last Update Submit

March 11, 2015

Conditions

Child Behavior

Keywords

siblingsfamilychild behaviorcritical illnesssocial support

Outcome Measures

Primary Outcomes (1)

  • To compare behavioral assessment scores of siblings of children who are critically ill to scores of the general population

    baseline and 6 months

Secondary Outcomes (1)

  • 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

Study Arms (2)

FU-1 feedback

EXPERIMENTAL
Behavioral: One week follow up assessment results

control group

NO INTERVENTION

Interventions

One week follow up assessment resultsBEHAVIORAL

FU-1 feedback group will receive child behavior assessment results and interpretation,and a brief intervention to encourage support options.

FU-1 feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Child BehaviorCritical Illness

Condition Hierarchy (Ancestors)

BehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chris Feudtner, MD, PhD, MPH

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2009

First Posted

June 3, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

March 12, 2015

Record last verified: 2014-04

Locations

US(1)