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Evaluating Effectiveness of Dyadic Prolonged Exposure on 2-4 Years Old vs. Toddler-parent Focused Treatment

Primary Purpose

Post-Traumatic Stress Disorder in Children

Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Prolonged exposure
Child-parent Play Therapy
Sponsored by
Association for Children at Risk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder in Children focused on measuring Toddlers; Preschoolers; PTSD

Eligibility Criteria

18 Months - 66 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Hebrew speaking toddlers with PTSD related to traumatic experience that occured at least 1 month prior to the study enrollment
  2. Toddlers whose parents are living together

Exclusion Criteria:

  1. Toddlers which are still dealing with an active life threatening illness and are hence going through medical procedures.
  2. Toddlers with intelectual developmental disorder
  3. Toddlers with an active psychosis
  4. Toddlers with blindness or deafness
  5. Toddlers who are currently taking psychotropic medication
  6. Toddlers and parents that receive psycotherapy outside of the study for their PTSD symptoms
  7. Toddlers diagnozed with autism spectrum disorder
  8. Toddlers who were exposed to domestic or sexual violence

Sites / Locations

  • Rabin medical center
  • Association for Children at Risk's Cohen Harris Resilience Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prolonged exposure

Child-parent Play Therapy

Arm Description

See intervention description

see intervention description

Outcomes

Primary Outcome Measures

Change from baseline in post traumatic symptoms: clinical assessment and Young child ptsd checklist (YCPC, Scheeringa & Haslett, 2010).
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.

Secondary Outcome Measures

Beck Depression Inventory (BDI)
A self-report questionnaire for depression among adults
The Posttraumatic Stress Symptom Scale-Self report (PSS-SR; Foa, Riggs, Dancu & Rothbaum, 1993)
A self report questionnaire for the assessment of PTSD symptoms among adults
Posttraumatic Stress Cognitions Inventory (PTCI)
A self report questionnaire assessing post traumatic beliefs in adults
Parenting Sense of Competence Scale )PSOC; Gibaud -Wallstton & Wandersman, 1978)
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".

Full Information

First Posted
July 29, 2014
Last Updated
February 7, 2020
Sponsor
Association for Children at Risk
Collaborators
Geha Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT02226393
Brief Title
Evaluating Effectiveness of Dyadic Prolonged Exposure on 2-4 Years Old vs. Toddler-parent Focused Treatment
Official Title
Evaluating Effectiveness of Dyadic Prolonged Exposure Treatment on 2-4 Years Old vs. Toddler-parent Focused Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Recruitment
Study Start Date
October 2014 (undefined)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association for Children at Risk
Collaborators
Geha Mental Health Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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: PE would more effective than TP-CT in reducing post-traumatic symptoms in toddlers. PE would more effective than TP-CT in reducing post-traumatic symptoms of the toddlers' parents. 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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder in Children
Keywords
Toddlers; Preschoolers; PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prolonged exposure
Arm Type
Experimental
Arm Description
See intervention description
Arm Title
Child-parent Play Therapy
Arm Type
Active Comparator
Arm Description
see intervention description
Intervention Type
Behavioral
Intervention Name(s)
Prolonged exposure
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Child-parent Play Therapy
Intervention 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.
Primary Outcome Measure Information:
Title
Change from baseline in post traumatic symptoms: clinical assessment and Young child ptsd checklist (YCPC, Scheeringa & Haslett, 2010).
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.
Time Frame
Parents' pre-treatment, post treatment and follow-up 3,6,12 months post treatment
Secondary Outcome Measure Information:
Title
Beck Depression Inventory (BDI)
Description
A self-report questionnaire for depression among adults
Time Frame
Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
Title
The Posttraumatic Stress Symptom Scale-Self report (PSS-SR; Foa, Riggs, Dancu & Rothbaum, 1993)
Description
A self report questionnaire for the assessment of PTSD symptoms among adults
Time Frame
Parents' pre-treatment, during treatment (every 2 sessions), post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
Title
Posttraumatic Stress Cognitions Inventory (PTCI)
Description
A self report questionnaire assessing post traumatic beliefs in adults
Time Frame
Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
Title
Parenting Sense of Competence Scale )PSOC; Gibaud -Wallstton & Wandersman, 1978)
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".
Time Frame
Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
66 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hebrew speaking toddlers with PTSD related to traumatic experience that occured at least 1 month prior to the study enrollment Toddlers whose parents are living together Exclusion Criteria: Toddlers which are still dealing with an active life threatening illness and are hence going through medical procedures. Toddlers with intelectual developmental disorder Toddlers with an active psychosis Toddlers with blindness or deafness Toddlers who are currently taking psychotropic medication Toddlers and parents that receive psycotherapy outside of the study for their PTSD symptoms Toddlers diagnozed with autism spectrum disorder Toddlers who were exposed to domestic or sexual violence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orit Krispin, Phd
Organizational Affiliation
Schneider Children's Medical Center, Israel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lilach Rachamim, Phd
Official's Role
Study Director
Facility Information:
Facility Name
Rabin medical center
City
Petah-Tikva
Country
Israel
Facility Name
Association for Children at Risk's Cohen Harris Resilience Center
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

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Evaluating Effectiveness of Dyadic Prolonged Exposure on 2-4 Years Old vs. Toddler-parent Focused Treatment

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