Psychological Interventions in Siblings of Children With Cancer

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296907
• Other study ID #: PIGO-1
• Status: Completed
• Phase: N/A
• First received: February 24, 2006
• Last updated: July 27, 2012
• Start date: April 2006
• Est. completion date: December 2010

Study information

• Verified date: July 2012
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 16 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Brief psychological intervention
Psychoeducation, provision of medical knowledge, coping skills training

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Zurich, Psychosomatic and Psychiatry	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Prchal A, Graf A, Bergstraesser E, Landolt MA. A two-session psychological intervention for siblings of pediatric cancer patients: a randomized controlled pilot trial. Child Adolesc Psychiatry Ment Health. 2012 Jan 11;6(1):3. doi: 10.1186/1753-2000-6-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KIDSCREEN: health-related quality of life		baseline, 3 and 6 months post intervention	No
Primary	UCLA Child PTSD Reaction Index		baseline, 3 and 6 months post intervention	No
Primary	DIKJ (Depression-Inventory for Children and Adolescents)		baseline, 3 and 6 months post intervention	No
Primary	Child Behavior Checklist		Baseline, 3 and 6 months post intervention	No
Primary	Spence Children's Anxiety Scale		baseline, 3 and 6 months post intervention	No
Secondary	Posttraumatic Distress Scale		baseline, 3 and 6 months post intervention	No
Secondary	Symptom Checklist 27		baseline, 3 and 6 months post intervention	No