Recognizing and Treating Psychosocial Stress Among Children With Complex Heart Problems

Psychosocial Stress Clinical Trial

Official title:

Recognizing and Treating Psychosocial Stress Among Children With Complex Heart Problems

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02002780
• Other study ID #: 1000020209
• Status: Withdrawn
• Phase: Phase 2
• First received: December 2, 2013
• Last updated: December 2, 2013
• Start date: January 2011
• Est. completion date: November 2011

Study information

• Verified date: December 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychosocial Stress

Intervention

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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in psychosocial stress scores resulting from the intervention		Baseline and end of study (at about month 10 -11)	No