NCT00296907

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

4.3 years

First QC Date

February 24, 2006

Last Update Submit

July 27, 2012

Conditions

Cancer

Keywords

cancersiblingsbehaviorpsychological adaptationintervention

Outcome Measures

Primary Outcomes (5)

  • KIDSCREEN: health-related quality of life

    baseline, 3 and 6 months post intervention

  • UCLA Child PTSD Reaction Index

    baseline, 3 and 6 months post intervention

  • DIKJ (Depression-Inventory for Children and Adolescents)

    baseline, 3 and 6 months post intervention

  • Child Behavior Checklist

    Baseline, 3 and 6 months post intervention

  • Spence Children's Anxiety Scale

    baseline, 3 and 6 months post intervention

Secondary Outcomes (2)

  • Posttraumatic Distress Scale

    baseline, 3 and 6 months post intervention

  • Symptom Checklist 27

    baseline, 3 and 6 months post intervention

Study Arms (1)

Psychological Intervention

EXPERIMENTAL

2-session psychological intervention

Behavioral: Brief psychological intervention

Interventions

Brief psychological interventionBEHAVIORAL

Psychoeducation, provision of medical knowledge, coping skills training

Psychological Intervention

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital Zurich, Psychosomatic and Psychiatry

Zurich, CH-8032, Switzerland

Location

Related 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.

    PMID: 22236392RESULT

MeSH Terms

Conditions

NeoplasmsBehavior

Study Officials

  • Markus A Landolt, PhD

    University Children's Hospital Zurich, Psychosomatic and Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2006

First Posted

February 27, 2006

Study Start

April 1, 2006

Primary Completion

July 1, 2010

Study Completion

December 1, 2010

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations

CH(1)