Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00521768
Status:
WITHDRAWN
Last Update Posted:
2015-07-07
First Post:
2007-08-27
Brief Title:
Effectiveness of Prolonged Exposure of PTSD in a Community Setting of PTSD Sufferers
Sponsor:
HaEmek Medical Center Israel
Organization:
HaEmek Medical Center Israel
Study Overview
Official Title:
None
Status:
WITHDRAWN
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Childrens 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
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 Childrens 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 diagnosisRecent 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 HaEmek Medical Center child and adolescent psychiatric clinic
HaEmek 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 HaEmek 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 EvaluationInstruments 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
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 diagnosisRecent 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 HaEmek Medical Center child and adolescent psychiatric clinic
HaEmek 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 HaEmek 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 EvaluationInstruments 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None