Psychological Interventions in Siblings of Children With Cancer

July 27, 2012 updated by: University Children's Hospital, Zurich

Psychological Interventions in Siblings of Children With Cancer: a Randomized Controlled Study

The purpose of the study is to evaluate the effectiveness of a two-session brief psychological intervention in siblings of pediatric cancer patients with regard to behavior problems and depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Within a randomized controlled design the effects of a brief two-session psychological intervention (child, parents) shall be studied in 30 siblings of newly diagnosed pediatric cancer patients. After a baseline assessment 3-4 weeks after diagnosis participants are randomly assigned to an intervention or waiting list group. Both are re-assessed at 3 and 6 months by means of standardized questionnaires assessing psychological adaptation and behavior. The intervention is provided to the waiting list group after the 6-month assessment.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, CH-8032
        • University Children's Hospital Zurich, Psychosomatic and Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

brother or sister with newly diagnosed cancer treated at the University Children's Hospital command of the German language normal developmental level

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psychological Intervention
2-session psychological intervention
Behavioral: Brief psychological intervention
Psychoeducation, provision of medical knowledge, coping skills training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
KIDSCREEN: health-related quality of life
Time Frame: baseline, 3 and 6 months post intervention
baseline, 3 and 6 months post intervention
UCLA Child PTSD Reaction Index
Time Frame: baseline, 3 and 6 months post intervention
baseline, 3 and 6 months post intervention
DIKJ (Depression-Inventory for Children and Adolescents)
Time Frame: baseline, 3 and 6 months post intervention
baseline, 3 and 6 months post intervention
Child Behavior Checklist
Time Frame: Baseline, 3 and 6 months post intervention
Baseline, 3 and 6 months post intervention
Spence Children's Anxiety Scale
Time Frame: baseline, 3 and 6 months post intervention
baseline, 3 and 6 months post intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Posttraumatic Distress Scale
Time Frame: baseline, 3 and 6 months post intervention
baseline, 3 and 6 months post intervention
Symptom Checklist 27
Time Frame: baseline, 3 and 6 months post intervention
baseline, 3 and 6 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Children's Hospital, Zurich

Investigators

  • Principal Investigator: Markus A Landolt, PhD, University Children's Hospital Zurich, Psychosomatic and Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 24, 2006

First Submitted That Met QC Criteria

February 24, 2006

First Posted (Estimate)

February 27, 2006

Study Record Updates

Last Update Posted (Estimate)

July 30, 2012

Last Update Submitted That Met QC Criteria

July 27, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PIGO-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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