<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/NCT02226393</url>
  </required_header>
  <id_info>
    <org_study_id>RMC147804ctil</org_study_id>
    <nct_id>NCT02226393</nct_id>
  </id_info>
  <brief_title>Evaluating Effectiveness of Dyadic Prolonged Exposure on 2-4 Years Old vs. Toddler-parent Focused Treatment</brief_title>
  <official_title>Evaluating Effectiveness of Dyadic Prolonged Exposure Treatment on 2-4 Years Old vs. Toddler-parent Focused Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association for Children at Risk</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Geha Mental Health Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Association for Children at Risk</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Traumatic events have potentially debilitating long-lasting effects on the child's normal&#xD;
      development and, therefore, should be effectively treated. Prolonged Exposure (PE) therapy&#xD;
      has been found to be effective in reducing posttraumatic stress disorder symptoms in adults&#xD;
      and in adolescents. It has not yet been tested in toddlers.&#xD;
&#xD;
      The purpose of this study is to examine the treatment efficacy of 2 methods of treatment for&#xD;
      toddlers with PTSD and their parents. A randomized control trial could examine the efficacy&#xD;
      of PE versus dyadic play therapy (TP-CT). Exploration of these questions under more rigorous&#xD;
      conditions would help broaden our knowledge about developmentally sensitive treatment tools&#xD;
      for this age group.&#xD;
&#xD;
      Our research hypotheses are:&#xD;
&#xD;
        1. PE would more effective than TP-CT in reducing post-traumatic symptoms in toddlers.&#xD;
&#xD;
        2. PE would more effective than TP-CT in reducing post-traumatic symptoms of the toddlers'&#xD;
           parents.&#xD;
&#xD;
        3. These results will be preserved in a follow-up of 3-6 months post treatment. Following&#xD;
           psychiatric assessment, 100 toddlers will be randomly assigned to PE and TP-CT (50&#xD;
           participants in each group).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Beyond what was detailed in the previous section of the brief summary, it should be noted&#xD;
      that the toddlers will be assessed and treated at least 1 month post-trauma and at least 1&#xD;
      month after discharge from hospital in order to avoid acute reaction either to the traumatic&#xD;
      event or to the medical procedures during their hospitalization and adjustment problems.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment&#xD;
  </why_stopped>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">September 2019</completion_date>
  <primary_completion_date type="Actual">September 2019</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in post traumatic symptoms: clinical assessment and Young child ptsd checklist (YCPC, Scheeringa &amp; Haslett, 2010).</measure>
    <time_frame>Parents' pre-treatment, post treatment and follow-up 3,6,12 months post treatment</time_frame>
    <description>Change from baseline in post traumatic symptoms will be assessed using the Classification of Mental Health and Developmental Disorders of Infancy and Early Childhood) and the Young Child PTSD Checklist (YCPC, Scheeringa &amp; Haslett, 2010). The YCPC assesses probable diagnosis formed the basis for the new DSM-5 disorder for posttraumatic stress disorder for children 6 years and younger.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory (BDI)</measure>
    <time_frame>Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment</time_frame>
    <description>A self-report questionnaire for depression among adults</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Posttraumatic Stress Symptom Scale-Self report (PSS-SR; Foa, Riggs, Dancu &amp; Rothbaum, 1993)</measure>
    <time_frame>Parents' pre-treatment, during treatment (every 2 sessions), post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment</time_frame>
    <description>A self report questionnaire for the assessment of PTSD symptoms among adults</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Posttraumatic Stress Cognitions Inventory (PTCI)</measure>
    <time_frame>Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment</time_frame>
    <description>A self report questionnaire assessing post traumatic beliefs in adults</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting Sense of Competence Scale )PSOC; Gibaud -Wallstton &amp; Wandersman, 1978)</measure>
    <time_frame>Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment</time_frame>
    <description>The Parenting Sense of Competency Scale (PSOC) was developed by Gibaud-Wallston as part of her PhD dissertation and presented at the American Psychological Association by Gibaud-Wallston and Wandersman in 1978. The PSOC is a 17 item scale, with 2 subscales. Each item is rated on a 6 point Likert scale anchored by 1 = &quot;Strongly Disagree&quot; and 6 = &quot;Strongly Agree&quot;.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Post-Traumatic Stress Disorder in Children</condition>
  <arm_group>
    <arm_group_label>Prolonged exposure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>See intervention description</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Child-parent Play Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>see intervention description</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Prolonged exposure</intervention_name>
    <description>The PE treatment includes 12-15 60 minutes' sessions. The 2 main components of the treatment are psychoeducation about common reactions to trauma and in-vivo exposures (gradual exposure to trauma related situations and objects) and repeated recounting of the traumatic memory, Trauma memory recounting and in-vivo exposures are conducted during several successive sessions so the child learns that the exposures themselves pose no real harm to him, indicating that when one confronts what one is afraid of it becomes easier to manage.</description>
    <arm_group_label>Prolonged exposure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Child-parent Play Therapy</intervention_name>
    <description>Is consisted of 12-15 weekly 60 minute sessions of parent-child centered therapy it focus on establishing a trusting, empowering, and validating therapeutic relationship. Participants are allowed to choose when, how, and whether or not to address their trauma memory. Therapists provide active listening, empathy,and encouragement to talk about feelings and express belief in the participants ability to cope. In sessions 4 and 8, participants are asked how they feel about their trauma. With this exception, participants direct the sessions.</description>
    <arm_group_label>Child-parent Play Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Hebrew speaking toddlers with PTSD related to traumatic experience that occured at&#xD;
             least 1 month prior to the study enrollment&#xD;
&#xD;
          2. Toddlers whose parents are living together&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Toddlers which are still dealing with an active life threatening illness and are hence&#xD;
             going through medical procedures.&#xD;
&#xD;
          2. Toddlers with intelectual developmental disorder&#xD;
&#xD;
          3. Toddlers with an active psychosis&#xD;
&#xD;
          4. Toddlers with blindness or deafness&#xD;
&#xD;
          5. Toddlers who are currently taking psychotropic medication&#xD;
&#xD;
          6. Toddlers and parents that receive psycotherapy outside of the study for their PTSD&#xD;
             symptoms&#xD;
&#xD;
          7. Toddlers diagnozed with autism spectrum disorder&#xD;
&#xD;
          8. Toddlers who were exposed to domestic or sexual violence&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>66 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Orit Krispin, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Schneider Children's Medical Center, Israel</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lilach Rachamim, Phd</last_name>
    <role>Study Director</role>
  </overall_official>
  <location>
    <facility>
      <name>Rabin medical center</name>
      <address>
        <city>Petah-Tikva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Association for Children at Risk's Cohen Harris Resilience Center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>February 7, 2020</last_update_submitted>
  <last_update_submitted_qc>February 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Toddlers; Preschoolers; PTSD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <!-- 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/NCT02226393
org study id: RMC147804ctil
nct id: NCT02226393
lead sponsor: 
collaborator: 
has dmc: Yes
Traumatic events have potentially debilitating long-lasting effects on the child's normal
      development and, therefore, should be effectively treated. Prolonged Exposure (PE) therapy
      has been found to be effective in reducing posttraumatic stress disorder symptoms in adults
      and in adolescents. It has not yet been tested in toddlers.

      The purpose of this study is to examine the treatment efficacy of 2 methods of treatment for
      toddlers with PTSD and their parents. A randomized control trial could examine the efficacy
      of PE versus dyadic play therapy (TP-CT). Exploration of these questions under more rigorous
      conditions would help broaden our knowledge about developmentally sensitive treatment tools
      for this age group.

      Our research hypotheses are:

        1. PE would more effective than TP-CT in reducing post-traumatic symptoms in toddlers.

        2. PE would more effective than TP-CT in reducing post-traumatic symptoms of the toddlers'
           parents.

        3. These results will be preserved in a follow-up of 3-6 months post treatment. Following
           psychiatric assessment, 100 toddlers will be randomly assigned to PE and TP-CT (50
           participants in each group).
Beyond what was detailed in the previous section of the brief summary, it should be noted
      that the toddlers will be assessed and treated at least 1 month post-trauma and at least 1
      month after discharge from hospital in order to avoid acute reaction either to the traumatic
      event or to the medical procedures during their hospitalization and adjustment problems.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in post traumatic symptoms: clinical assessment and Young child ptsd checklist (YCPC, Scheeringa & Haslett, 2010).
time frame: Parents' pre-treatment, post treatment and follow-up 3,6,12 months post treatment
description: Change from baseline in post traumatic symptoms will be assessed using the Classification of Mental Health and Developmental Disorders of Infancy and Early Childhood) and the Young Child PTSD Checklist (YCPC, Scheeringa & Haslett, 2010). The YCPC assesses probable diagnosis formed the basis for the new DSM-5 disorder for posttraumatic stress disorder for children 6 years and younger.
measure: Beck Depression Inventory (BDI)
time frame: Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
description: A self-report questionnaire for depression among adults
measure: The Posttraumatic Stress Symptom Scale-Self report (PSS-SR; Foa, Riggs, Dancu & Rothbaum, 1993)
time frame: Parents' pre-treatment, during treatment (every 2 sessions), post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
description: A self report questionnaire for the assessment of PTSD symptoms among adults
measure: Posttraumatic Stress Cognitions Inventory (PTCI)
time frame: Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
description: A self report questionnaire assessing post traumatic beliefs in adults
measure: Parenting Sense of Competence Scale )PSOC; Gibaud -Wallstton & Wandersman, 1978)
time frame: Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
description: The Parenting Sense of Competency Scale (PSOC) was developed by Gibaud-Wallston as part of her PhD dissertation and presented at the American Psychological Association by Gibaud-Wallston and Wandersman in 1978. The PSOC is a 17 item scale, with 2 subscales. Each item is rated on a 6 point Likert scale anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree".
arm group label: Prolonged exposure
arm group type: Experimental
description: See intervention description
arm group label: Child-parent Play Therapy
arm group type: Active Comparator
description: see intervention description
intervention type: Behavioral
intervention name: Prolonged exposure
description: The PE treatment includes 12-15 60 minutes' sessions. The 2 main components of the treatment are psychoeducation about common reactions to trauma and in-vivo exposures (gradual exposure to trauma related situations and objects) and repeated recounting of the traumatic memory, Trauma memory recounting and in-vivo exposures are conducted during several successive sessions so the child learns that the exposures themselves pose no real harm to him, indicating that when one confronts what one is afraid of it becomes easier to manage.
arm group label: Prolonged exposure
intervention type: Behavioral
intervention name: Child-parent Play Therapy
description: Is consisted of 12-15 weekly 60 minute sessions of parent-child centered therapy it focus on establishing a trusting, empowering, and validating therapeutic relationship. Participants are allowed to choose when, how, and whether or not to address their trauma memory. Therapists provide active listening, empathy,and encouragement to talk about feelings and express belief in the participants ability to cope. In sessions 4 and 8, participants are asked how they feel about their trauma. With this exception, participants direct the sessions.
arm group label: Child-parent Play Therapy
criteria: 
gender: All
minimum age: 18 Months
maximum age: 66 Months
healthy volunteers: No
last name: Orit Krispin, Phd
role: Principal Investigator
affiliation: Schneider Children's Medical Center, Israel
last name: Lilach Rachamim, Phd
role: Study Director
facility: 
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic