Recognizing and Treating Psychosocial Stress Among Children With Complex Heart Problems
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|ClinicalTrials.gov Identifier: NCT02002780|
Recruitment Status : Withdrawn (Study not started, investigator left the institution)
First Posted : December 6, 2013
Last Update Posted : December 6, 2013
|Condition or disease||Intervention/treatment||Phase|
|Psychosocial Stress||Behavioral: Day Camp||Phase 2|
This research will investigate the psychological stress experienced by children who have had surgery for a complex heart problem. Measures of quality of life among children with heart problems indicate that those 8 to 12 years of age have lower quality of life scores than younger or older children.
Children who survive a critical illness requiring a multi-day stay in a pediatric intensive care unit are at risk for a variety of psychiatric morbidities. Depression, anxiety and post-traumatic stress disorder occur in 7% to 28% of patients.
A systematic review of psychological adjustment among children with heart problems indicates that parent reports (but not child self-reports) are useful in detecting problems with psychological adjustment. While parent reports tend to identify increased social and behaviour problems, child self-reports indicate more frequent symptoms of depression compared to healthy peers.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Recognizing and Treating Psychosocial Stress Among Children With Complex Heart Problems|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Children identified during the screening phase of the project as having elevated, but not clinically defined, levels of psychosocial stress will be invited to participate in the intervention phase of this research if they are between 8 and 11 years of age.
Screening will identify 6 girls and 6 boys eligible and willing to participate in the intervention phase of the project.
Behavioral: Day Camp
The intervention will be delivered using a day camp structure, on a weekend or during school break in July 2011. Separate interventions will be offered for boys and girls. Each intervention will include two full days (0900 to 1600) of group activities lead by the researchers. Details of the "camp" activities will be developed by the researchers, based on the types of psychosocial stress identified during the screening phase of the project.
No Intervention: Control
All families that were screened during the screening phase of this study will complete the final screening instrument assessment, whether or not the child participated in the day camp intervention. The control group will be comprised of those families that did not participate in the intervention.
- Change in psychosocial stress scores resulting from the intervention [ Time Frame: Baseline and end of study (at about month 10 -11) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002780
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Brian McCrindle, MD||The Hospital for Sick Children, Toronto Canada|