Recognizing and Treating Psychosocial Stress Among Children With Complex Heart Problems

Phase 2

Withdrawn

• Conditions: Psychosocial Stress
• Interventions: Behavioral: Day Camp

• Registration Number: NCT02002780
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2013-12
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-02
• Last Update Submitted: 2013-12-02
• Study First Posted: 2013-12-06
• Last Update Posted: 2013-12-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects	Day Camp	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.

Primary Outcome Measures

Name	Time	Method
Change in psychosocial stress scores resulting from the intervention	Baseline and end of study (at about month 10 -11)

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada