Psychological Interventions in Siblings of Children With Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT00296907
First received: February 24, 2006
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Cancer
Behavioral: Brief psychological intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Psychological Interventions in Siblings of Children With Cancer: a Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by University Children's Hospital, Zurich:

Primary Outcome Measures:
  • KIDSCREEN: health-related quality of life [ Time Frame: baseline, 3 and 6 months post intervention ] [ Designated as safety issue: No ]
  • UCLA Child PTSD Reaction Index [ Time Frame: baseline, 3 and 6 months post intervention ] [ Designated as safety issue: No ]
  • DIKJ (Depression-Inventory for Children and Adolescents) [ Time Frame: baseline, 3 and 6 months post intervention ] [ Designated as safety issue: No ]
  • Child Behavior Checklist [ Time Frame: Baseline, 3 and 6 months post intervention ] [ Designated as safety issue: No ]
  • Spence Children's Anxiety Scale [ Time Frame: baseline, 3 and 6 months post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Posttraumatic Distress Scale [ Time Frame: baseline, 3 and 6 months post intervention ] [ Designated as safety issue: No ]
  • Symptom Checklist 27 [ Time Frame: baseline, 3 and 6 months post intervention ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2006
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychological Intervention
2-session psychological intervention
Behavioral: Brief psychological intervention
Psychoeducation, provision of medical knowledge, coping skills training

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.

  Eligibility

Ages Eligible for Study:   7 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00296907

Locations
Switzerland
University Children's Hospital Zurich, Psychosomatic and Psychiatry
Zurich, Switzerland, CH-8032
Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
Principal Investigator: Markus A Landolt, PhD University Children's Hospital Zurich, Psychosomatic and Psychiatry
  More Information

Publications:
Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT00296907     History of Changes
Other Study ID Numbers: PIGO-1
Study First Received: February 24, 2006
Last Updated: July 27, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Children's Hospital, Zurich:
cancer
siblings
behavior
psychological adaptation
intervention

ClinicalTrials.gov processed this record on August 28, 2014