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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Recruitment Status : Withdrawn (Study not started, investigator left the institution)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
Sponsor:
Information provided by (Responsible Party):
Brian McCrindle, The Hospital for Sick Children

Brief Summary:
This research project has two goals. The first goal is to find one or more questionnaires that can accurately identify children who are experiencing high levels of stress or emotional health issues during a regular clinic visit. The second goal is to find out whether children who are experiencing stress or emotional health problems are able to attend a day camp programme and complete activities at home that are designed to help them cope better with stress. We also want to find out if the day camp and home activities are helpful.

Condition or disease Intervention/treatment Phase
Psychosocial Stress Behavioral: Day Camp Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Subjects

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.



Primary Outcome Measures :
  1. Change in psychosocial stress scores resulting from the intervention [ Time Frame: Baseline and end of study (at about month 10 -11) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children who have had surgery for a complex heart problem
  • children with heart problems requiring on-going medical care
  • age 6 to 12 years

Exclusion Criteria:

  • the child has had an intervention (catheterization or surgery) within the previous 6 months,
  • the child has an identified cognitive or emotional health disability,
  • the child or parents do not speak English sufficiently well to respond to the screening instruments, or
  • the child's clinic visit is for an acute illness or change in health status.

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Brian McCrindle, MD The Hospital for Sick Children, Toronto Canada
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Responsible Party: Brian McCrindle, Staff Cardiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02002780    
Other Study ID Numbers: 1000020209
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: December 2013
Keywords provided by Brian McCrindle, The Hospital for Sick Children:
pediatrics
stress
cardiac surgery