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Recognizing and Treating Psychosocial Stress Among Children With Complex Heart Problems

Recognizing and Treating Psychosocial Stress Among Children With Complex Heart Problems

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02002780
Enrollment
0
Registered
2013-12-06
Start date
2011-01-31
Completion date
2011-11-30
Last updated
2013-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosocial Stress

Keywords

pediatrics, stress, cardiac surgery

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.

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.

Interventions

BEHAVIORALDay 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.

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change in psychosocial stress scores resulting from the interventionBaseline and end of study (at about month 10 -11)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026