Recognizing and Treating Psychosocial Stress Among Children With Complex Heart Problems

NCT02002780 | Withdrawn Phase 2

• 1 other identifier: 1000020209
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosocial Stress

Keywords

pediatrics; stress; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Change in psychosocial stress scores resulting from the intervention

  Baseline and end of study (at about month 10 -11)

Study Arms (2)

Subjects

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Day Camp 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.

Subjects

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Study Officials

• Brian McCrindle, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiologist

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: January 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 6, 2013

Record last verified: 2013-12

Locations

CA (1)