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Effectiveness of Prolonged Exposure of PTSD in a Community Setting of PTSD Sufferers

Primary Purpose

Post Traumatic Stress Disorder, Anxiety Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Prolonged exposure
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Post Traumatic Stress Disorder focused on measuring Post traumatic stress disorder, Anxiety disorder, Comunity base intervention, Education, Behavioural treatment

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children age 6 to 18
  • Language spoken: Hebrew
  • DSM- IV R diagnosis: PTSD
  • Anxiety disorder

Exclusion Criteria:

  • Children presenting with psychotic symptoms,
  • Children presenting with mental retardation

Sites / Locations

  • HaEmek Medical Center - Psychiatry Department

Outcomes

Primary Outcome Measures

CDI questionaire

Secondary Outcome Measures

Full Information

First Posted
August 27, 2007
Last Updated
July 6, 2015
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT00521768
Brief Title
Effectiveness of Prolonged Exposure of PTSD in a Community Setting of PTSD Sufferers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

5. Study Description

Brief Summary
Introduction: Efforts to bridge the gap between research based treatment modalities advancements and clinical practice have received the highest priority in the research community. In the child psychiatry field there is an urging need to promote bridging this gap. Parents and child health providers hesitate to refer children to child psychiatrist due to stigma but also due to lack of awareness of available and efficient treatment options. In the field of trauma treatment another reason for lack of treatment is lack of recognition of trauma related symptoms in children. After the second Lebanon war scarce referrals to psychiatric clinics have been registered and access to treatment is low as indicated by 20 referrals in the past year to Emek Hospital. We propose to explore the effectiveness of well-established adult treatment for PTSD, the Prolonged Exposure (PE), in community-based general pediatric clinics, serving an underprivileged diverse population. Methods: Twenty children age 6 to 18 attending general pediatric clinic and in Afula region will included. children will be diagnosed using the Hebrew translation of the Childhood version of the Schedule for Affective Disorders and Schizophrenia (Apter et al., 1989 Children will receive the Children's Depression Inventory (CDI) and the. CPSS All subjects will be treated with a manualized 12-week Prolonged Exposure protocol Ratings will be made at baseline, 6weeks, and 12 weeks using CDI and CPSS Hypothesis: 1. PE adapted for pediatric population will be effective in treating single-event traumas in a community setting.
Detailed Description
SPECIFIC AIMS The aim of the study is to examine the effectiveness of PE treatment of PTSD in community settings BACKGROUND AND SIGNIFICANCE There is a great need to apply scientific achievements in behavioral science research to community-based clinical settings. Many recent advances in psychology with significant potential to improve clinical practice and intervention have not yet been utilized in clinical settings. A recent report of the NIH National Advisory Mental Health Council Behavioral Science Workgroup has defined this approach, "Translational research", as follows: "Translational research in the behavioral and social sciences addresses how basic behavioral processes inform the diagnosis, prevention, treatment and delivery of services for mental illness, and conversely, how knowledge of mental illness increases our understanding of basic behavioral processes. " (NIH publication, 2001). PTSD in children is a well established diagnosis.Recent studies have shown 30 % of children presenting with PTSD symptoms after the second Lebanon war Parents and child health providers hesitate to refer children to child psychiatrist due to stigma but also due to lack of awareness of available and efficient treatment options. In the field of trauma treatment another reason for lack of treatment is lack of recognition of trauma related symptoms in children. After the second Lebanon war scarce referrals to psychiatric clinics have been registered and access to treatment is low as indicated by 20 referrals in the past year to Ha'Emek Medical Center child and adolescent psychiatric clinic. Ha'Emek medical center is initiating a community base PTSD treatment program to children attending general pediatric clinics. We propose to explore the effectiveness of well-established adult treatment for PTSD, the Prolonged Exposure (PE), in community-based general pediatric clinics, serving an underprivileged diverse population. RESEARCH DESIGN AND METHODS Subjects: Twenty children age 6 to 18 referred to the community base PTSD treatment program offered by the Ha'Emek medical center in Afula will be include: All families referred to the PTSD treatment program will be offered to participate in the research protocol. We expect 50 families to be included in the treatment program. Only subject whose both parents will agree for inclusion in the research program will be included. DSM- IV R diagnosis: PTSD Evaluation/Instruments Socio-Demographics Data: Child: Age, Sex, grade level and medical history. Parents: Age, marital status, ethnic background, country of birth, language spoken at home, education level, occupational status. Trauma History: Type of trauma, distance from Katushe fall Kiddy SADS: a semi structural interview CDI: a self report questionnaire CPSS: a self report questionnaire Procedures: Parents will be informed of the goals of the study by their primary child health provider, and will be offered the opportunity to meet with the mental health worker prior to enrollment.. Parents will be told that their participation in the research is voluntary and anonymous and their refusal to participate will not affect the services they receive by the project. Children who will be diagnosed as having PTSD will be offered 12 sessions treatment by PE. CDI and CPSS will be scored at time 0, time 6 weeks and time 12 weeks

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Anxiety Disorder
Keywords
Post traumatic stress disorder, Anxiety disorder, Comunity base intervention, Education, Behavioural treatment

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Prolonged exposure
Primary Outcome Measure Information:
Title
CDI questionaire
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children age 6 to 18 Language spoken: Hebrew DSM- IV R diagnosis: PTSD Anxiety disorder Exclusion Criteria: Children presenting with psychotic symptoms, Children presenting with mental retardation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziva Bracha, MD
Organizational Affiliation
HaEmek MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
HaEmek Medical Center - Psychiatry Department
City
Afula
ZIP/Postal Code
18101
Country
Israel

12. IPD Sharing Statement

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Effectiveness of Prolonged Exposure of PTSD in a Community Setting of PTSD Sufferers

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