Clinical trial NCT03467464: The Efficacy of EMDR in Youngsters With Autism
Official title: The Efficacy of EMDR in Youngsters With Autism: an Explorative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism, EMDR; Children
Lead sponsor: Karakter Kinder- en Jeugdpsychiatrie
Sponsor class: OTHER
Collaborators: name: Fonds Psychische Gezondheid
First posted: 2018-03-16
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (N=20).

Intervention: 10 weekly EMDR sessions.

Main study parameters/endpoints: 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 (i.e. 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with ASD (with or without comorbid psychiatric disorders, except PTSD and anxiety disorders)
* Full-scale IQ of 80 or more
* Able to understand and speak Dutch

Exclusion Criteria:

* Receiving other treatments than medication on a stable dosage.
* PTSD or other comorbid psychiatric disorders that require immediate and continuous treatment.

Primary outcomes:
measure: Change in autism symptoms
timeFrame: 0, 1, 2, 3 weeks before intervention; week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 of intervention; 1 and 12 weeks after intervention
measure: Change in autism symptoms
timeFrame: 3 weeks before intervention; 1 week after intervention
measure: Change in autism symptoms
timeFrame: 0, 1, 2, 3 weeks before intervention; week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 of intervention; 1 and 12 weeks after intervention
Secondary outcomes:
measure: Change in disease severity
timeFrame: 3 weeks before intervention; 1 and 12 weeks after intervention
measure: Change in experienced stress
timeFrame: 0, 1, 2, 3 weeks before intervention; week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 of intervention; 1 and 12 weeks after intervention
measure: Change in general well-being
timeFrame: 3 weeks before intervention; 1 and 12 weeks after intervention
measure: Change in working memory capacity
timeFrame: 3 weeks before intervention; 1 week after intervention
measure: Change in working memory capacity
timeFrame: 3 weeks before intervention; 1 week after intervention
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Karakter kinder- en jeugdpsychiatrie
state: Gelderland
Study officials:
affiliation: Karakter Child and Adolescent Psychiatry University Centre
name: Martine Van Dongen-Boomsma, PhD
role: PRINCIPAL_INVESTIGATOR
References: