Ignite Creation Date:
2024-05-06 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03467464
Status:
UNKNOWN
Last Update Posted:
2018-03-16
First Post:
2017-10-06
Brief Title:
The Efficacy of EMDR in Youngsters With Autism
Sponsor:
Karakter Kinder- en Jeugdpsychiatrie
Organization:
Karakter Kinder- en Jeugdpsychiatrie
Study Overview
Official Title:
The Efficacy of EMDR in Youngsters With Autism an Explorative Study
Status:
UNKNOWN
Status Verified Date:
2017-10
Last Known Status:
RECRUITING
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:
EYE-catcher
Brief Summary:
Rationale Currently for youngsters there is no treatment available that directly targets the core symptoms of autism EMDR is hypothesized to improve the core symptoms of ASD by reducing the generally high stress levels experienced during social interactions and increasing the functional connectivity in neuronal networks associated with executive functioning and limbic circuitry
Objective The primary objective of the study is to determine if EMDR reduces the core symptoms of ASD and daily experienced stress in youngsters diagnosed with ASD
Study design Longitudinal multiple single case studies Study population Youngsters aged 12-21 years who are diagnosed with ASD and have a full-scale IQ of 80 or more N20
Intervention 10 weekly EMDR sessions
Main study parametersendpoints The main endpoint of the study are autism symptoms which will be assessed using the Social Responsiveness Scale SRS-A and the Autism Diagnostic Observation Schedule ADOS 2 The SRS-A will be administered prior during and after treatment The ADOS 2 will be administered prior to treatment and after treatment completion In addition we will also administer the Trauma Symptom Investigation Form in Autism Spectrum Disorders TIF-ASD questionnaire prior to during and after treatment Furthermore to answer more fundamental questions concerning the working mechanism of EMDR in ASD other secondary outcome measures ie PSS-10 AWMA-2 will be included
Nature and extent of the burden and risks associated with participation benefit and group relatedness Participants are expected to benefit from treatment The risks associated with study participation are considered negligible and the burden associated with participation is estimated as low
Objective The primary objective of the study is to determine if EMDR reduces the core symptoms of ASD and daily experienced stress in youngsters diagnosed with ASD
Study design Longitudinal multiple single case studies Study population Youngsters aged 12-21 years who are diagnosed with ASD and have a full-scale IQ of 80 or more N20
Intervention 10 weekly EMDR sessions
Main study parametersendpoints The main endpoint of the study are autism symptoms which will be assessed using the Social Responsiveness Scale SRS-A and the Autism Diagnostic Observation Schedule ADOS 2 The SRS-A will be administered prior during and after treatment The ADOS 2 will be administered prior to treatment and after treatment completion In addition we will also administer the Trauma Symptom Investigation Form in Autism Spectrum Disorders TIF-ASD questionnaire prior to during and after treatment Furthermore to answer more fundamental questions concerning the working mechanism of EMDR in ASD other secondary outcome measures ie PSS-10 AWMA-2 will be included
Nature and extent of the burden and risks associated with participation benefit and group relatedness Participants are expected to benefit from treatment The risks associated with study participation are considered negligible and the burden associated with participation is estimated as low
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None