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Recognizing and Treating Psychosocial Stress Among Children With Complex Heart Problems

NCT ID: NCT02002780

Last Updated: 2013-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-11-30

Brief Summary

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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

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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.

Conditions

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Psychosocial Stress

Keywords

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pediatrics stress cardiac surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Day Camp

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Brian McCrindle

Staff Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian McCrindle, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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1000020209

Identifier Type: -

Identifier Source: org_study_id