NCT01704885

Brief Summary

The goal of this study is to determine whether a brief (three 20-30 minute session) cognitive-behavioral play intervention will improve coping skills and adjustment for siblings of children diagnosed with cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Sep 2011

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 3, 2015

Status Verified

July 1, 2015

Enrollment Period

3.8 years

First QC Date

October 9, 2012

Last Update Submit

July 30, 2015

Conditions

Any Cancer Diagnosis

Keywords

Childhood CancerSibling Play interventionSibling Behavioral InterventionSiblings of Cancer Patients

Outcome Measures

Primary Outcomes (3)

  • Number of children with increase in coping skills after intervention

    Compared to the active control, children in the play intervention group will have increased coping skills after intervention.

    4 weeks

  • Number of children with better psychological adjustment following intervention

    Compared to the active control, children in the play intervention group will have better psychological adjustment following intervention.

    4 weeks

  • Number of parents with decreased parenting stress following intervention

    Parents of children in the play intervention group will report decreased parenting stress following the intervention.

    4 weeks

Study Arms (2)

Active Control Group

SHAM COMPARATOR

Children in the active control group will play with puzzles, a building toy, or color. The play facilitator will praise the child and interact at a similar rate to control for interaction with a caring adult.

Other: Questionnaires

Play Intervention

EXPERIMENTAL

children in the play intervention group will be given 3 story stems that they are asked to play out with the goal of helping the main character "feel better" (see session scripts). The play facilitator will play with the child, modeling and praising use of positive coping skills. In the first session the play facilitator will focus on positive self-statements, in the second session the play facilitator will focus on problem-solving, and a combination of these two approaches will be used in the final session. The child will be allowed to make up a story about whatever they want before ending each session.

Behavioral: Play InterventionOther: Questionnaires

Interventions

Play InterventionBEHAVIORAL
Also known as: Story Stems to play out, Problem solving, positive self-statements, make up a story
Play Intervention
QuestionnairesOTHER
Also known as: Demographic questionnaire, Parent/Well-Sibling Communication Measure, BASC-2 (Behavior Assessment System for Children-Second Edition), RSQ (Response to Stress Questionnaire), PSI-SF (Parenting Stress Index-Short Form), Mood Assessment, Perceived self-efficacy, ALTTIQ (Assessment of Life Threat and Treatment Intensity Questionnaire), APS (Affect in Play Scale) or APS-P, SPQ (Sibling Perception Questionnaire), Assessment of treatment satisfaction, Free play assessment
Active Control GroupPlay Intervention

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Families who have had children diagnosed with any type of cancer in the past year.
  • At least one sibling between the ages of 4 and 10 years old
  • Patients will be targeted 1-2 months after diagnosis, but could be included in the study up to 12 months following diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Play TherapySurveys and Questionnaires

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Karla Fehr, M.A.

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2012

First Posted

October 12, 2012

Study Start

September 1, 2011

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 3, 2015

Record last verified: 2015-07

Locations

US(1)