<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01704885</url>
  </required_header>
  <id_info>
    <org_study_id>CASE4Z11</org_study_id>
    <secondary_id>CC00130</secondary_id>
    <nct_id>NCT01704885</nct_id>
  </id_info>
  <brief_title>A Cognitive- Behavioral Play Intervention for Siblings of Children Diagnosed With Cancer</brief_title>
  <official_title>A Cognitive- Behavioral Play Intervention for Siblings of Children Diagnosed With Cancer: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to determine whether a brief (three 20-30 minute session)&#xD;
      cognitive-behavioral play intervention will improve coping skills and adjustment for siblings&#xD;
      of children diagnosed with cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim 1: Assess baseline adjustment, coping, pretend play, parenting stress, and family&#xD;
      interactions.&#xD;
&#xD;
        -  Hypothesis 1a: Children with siblings diagnosed with cancer will have lower levels of&#xD;
           adjustment, coping skills, and pretend play compared to previous sample norms.&#xD;
&#xD;
        -  Hypothesis 1b: The child's adjustment will be mediated by factors related to their&#xD;
           involvement in the sibling's medical care, such as parent's level of communication&#xD;
           regarding their sibling's illness, frequent isolation from the family and other social&#xD;
           support, time since their sibling's diagnosis, and parenting stress. -Hypothesis 1c:&#xD;
           Parents of children diagnosed with cancer will report higher levels of parenting stress&#xD;
           compared to previous sample norms.&#xD;
&#xD;
      Aim 2: Assess outcome of three play intervention sessions focusing on increasing coping and&#xD;
      adjustment.&#xD;
&#xD;
        -  Hypothesis 2a: Compared to the active control, children in the play intervention group&#xD;
           will have increased coping skills after intervention.&#xD;
&#xD;
        -  Hypothesis 2b: Compared to the active control, children in the play intervention group&#xD;
           will have better psychological adjustment following intervention.&#xD;
&#xD;
        -  Hypothesis 2c: Parents of children in the play intervention group will report decreased&#xD;
           parenting stress following the intervention.&#xD;
&#xD;
      Once parents consent to participate and their child provides assent, they and their child&#xD;
      will complete the baseline questionnaires and measures. Immediately following completion of&#xD;
      the baseline measures, the child will be randomly assigned to either the play intervention or&#xD;
      active control group.Children will also be asked to rate their mood at the beginning of each&#xD;
      play session. The outcome parent and child questionnaires will be administered again at a&#xD;
      session approximately one week after the third play session, for a total of four play&#xD;
      sessions each spaced approximately one week apart. Children will also be asked to rate their&#xD;
      satisfaction with the treatment at the outcome session (e.g., &quot;How much did you like being a&#xD;
      part of this study?&quot;).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow Accrual&#xD;
  </why_stopped>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of children with increase in coping skills after intervention</measure>
    <time_frame>4 weeks</time_frame>
    <description>Compared to the active control, children in the play intervention group will have increased coping skills after intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of children with better psychological adjustment following intervention</measure>
    <time_frame>4 weeks</time_frame>
    <description>Compared to the active control, children in the play intervention group will have better psychological adjustment following intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of parents with decreased parenting stress following intervention</measure>
    <time_frame>4 weeks</time_frame>
    <description>Parents of children in the play intervention group will report decreased parenting stress following the intervention.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Any Cancer Diagnosis</condition>
  <arm_group>
    <arm_group_label>Active Control Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Play Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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 &quot;feel better&quot; (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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Play Intervention</intervention_name>
    <arm_group_label>Play Intervention</arm_group_label>
    <other_name>Story Stems to play out</other_name>
    <other_name>Problem solving</other_name>
    <other_name>positive self-statements</other_name>
    <other_name>make up a story</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <arm_group_label>Active Control Group</arm_group_label>
    <arm_group_label>Play Intervention</arm_group_label>
    <other_name>Demographic questionnaire</other_name>
    <other_name>Parent/Well-Sibling Communication Measure</other_name>
    <other_name>BASC-2 (Behavior Assessment System for Children-Second Edition)</other_name>
    <other_name>RSQ (Response to Stress Questionnaire)</other_name>
    <other_name>PSI-SF (Parenting Stress Index-Short Form)</other_name>
    <other_name>Mood Assessment</other_name>
    <other_name>Perceived self-efficacy</other_name>
    <other_name>ALTTIQ (Assessment of Life Threat and Treatment Intensity Questionnaire)</other_name>
    <other_name>APS (Affect in Play Scale) or APS-P</other_name>
    <other_name>SPQ (Sibling Perception Questionnaire)</other_name>
    <other_name>Assessment of treatment satisfaction</other_name>
    <other_name>Free play assessment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Families who have had children diagnosed with any type of cancer in the past year.&#xD;
&#xD;
          -  At least one sibling between the ages of 4 and 10 years old&#xD;
&#xD;
          -  Patients will be targeted 1-2 months after diagnosis, but could be included in the&#xD;
             study up to 12 months following diagnosis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karla Fehr, M.A.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Case Western Reserve University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>July 30, 2015</last_update_submitted>
  <last_update_submitted_qc>July 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Childhood Cancer</keyword>
  <keyword>Sibling Play intervention</keyword>
  <keyword>Sibling Behavioral Intervention</keyword>
  <keyword>Siblings of Cancer Patients</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01704885
org study id: CASE4Z11
secondary id: CC00130
nct id: NCT01704885
lead sponsor: 
has dmc: Yes
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.
Aim 1: Assess baseline adjustment, coping, pretend play, parenting stress, and family
      interactions.

        -  Hypothesis 1a: Children with siblings diagnosed with cancer will have lower levels of
           adjustment, coping skills, and pretend play compared to previous sample norms.

        -  Hypothesis 1b: The child's adjustment will be mediated by factors related to their
           involvement in the sibling's medical care, such as parent's level of communication
           regarding their sibling's illness, frequent isolation from the family and other social
           support, time since their sibling's diagnosis, and parenting stress. -Hypothesis 1c:
           Parents of children diagnosed with cancer will report higher levels of parenting stress
           compared to previous sample norms.

      Aim 2: Assess outcome of three play intervention sessions focusing on increasing coping and
      adjustment.

        -  Hypothesis 2a: Compared to the active control, children in the play intervention group
           will have increased coping skills after intervention.

        -  Hypothesis 2b: Compared to the active control, children in the play intervention group
           will have better psychological adjustment following intervention.

        -  Hypothesis 2c: Parents of children in the play intervention group will report decreased
           parenting stress following the intervention.

      Once parents consent to participate and their child provides assent, they and their child
      will complete the baseline questionnaires and measures. Immediately following completion of
      the baseline measures, the child will be randomly assigned to either the play intervention or
      active control group.Children will also be asked to rate their mood at the beginning of each
      play session. The outcome parent and child questionnaires will be administered again at a
      session approximately one week after the third play session, for a total of four play
      sessions each spaced approximately one week apart. Children will also be asked to rate their
      satisfaction with the treatment at the outcome session (e.g., "How much did you like being a
      part of this study?").
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Number of children with increase in coping skills after intervention
time frame: 4 weeks
description: Compared to the active control, children in the play intervention group will have increased coping skills after intervention.
measure: Number of children with better psychological adjustment following intervention
time frame: 4 weeks
description: Compared to the active control, children in the play intervention group will have better psychological adjustment following intervention.
measure: Number of parents with decreased parenting stress following intervention
time frame: 4 weeks
description: Parents of children in the play intervention group will report decreased parenting stress following the intervention.
arm group label: Active Control Group
arm group type: Sham Comparator
description: 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.
arm group label: Play Intervention
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: Play Intervention
arm group label: Play Intervention
other name: Story Stems to play out
other name: Problem solving
other name: positive self-statements
other name: make up a story
intervention type: Other
intervention name: Questionnaires
arm group label: Active Control Group
arm group label: Play Intervention
other name: Demographic questionnaire
other name: Parent/Well-Sibling Communication Measure
other name: BASC-2 (Behavior Assessment System for Children-Second Edition)
other name: RSQ (Response to Stress Questionnaire)
other name: PSI-SF (Parenting Stress Index-Short Form)
other name: Mood Assessment
other name: Perceived self-efficacy
other name: ALTTIQ (Assessment of Life Threat and Treatment Intensity Questionnaire)
other name: APS (Affect in Play Scale) or APS-P
other name: SPQ (Sibling Perception Questionnaire)
other name: Assessment of treatment satisfaction
other name: Free play assessment
criteria: 
gender: All
minimum age: 4 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Karla Fehr, M.A.
role: Principal Investigator
affiliation: Case Western Reserve University
facility: 
country: United States
responsible party type: Sponsor