The Efficacy of EMDR in Youngsters With Autism
- Conditions
- Autism Spectrum Disorder
- Interventions
- Other: Eye Movement Desensitization and Reprocessing (EMDR)
- Registration Number
- NCT03467464
- Lead Sponsor
- Karakter Kinder- en Jeugdpsychiatrie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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
- Receiving other treatments than medication on a stable dosage.
- PTSD or other comorbid psychiatric disorders that require immediate and continuous treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Eye Movement Desensitization and Reprocessing (EMDR) EMDR treatment
- Primary Outcome Measures
Name Time Method Change in autism symptoms 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 Using the Trauma Symptom Investigation Form in Autism Spectrum Disorders (TIF-ASD) changes in autism symptoms prior to, during, and after treatment will be assessed. The TIF-ASD assesses the impact of traumatic events on five core symptoms of autism: 1) social and (verbal) communication skills; 2) behavioral problems; 3) stereotypical \& ritualistic behaviors; 4) self-care skills; 5) vegetative symptoms. The total scale consists of 20 items which are completed by an observer (in our case the parents). Items are answered on a 5-point scale ranging from never to always. Completing all items takes about 5 minutes. The TIF-ASD is the only measurement, assessing the traumatic symptoms and behavioral aspects related to ASD due to traumatic events.
- Secondary Outcome Measures
Name Time Method Change in disease severity 3 weeks before intervention; 1 and 12 weeks after intervention Youngsters' disease severity and global improvement will be assessed with the Clinical Global Impression Scales (CGI). To assess severity and afterwards improvement, both pre- and post-treatment assessments will be conducted. Assessment are conducted by a clinician who observes a youngster for about 15 minutes while interacting with others. Based on one's past experience with similar patients, the CGI-S enables a clinician to rate the severity of a patient's illness. Severity is assessed on a 7-point scale ranging from not at all ill to extremely ill. Opposed to the CGI-S, the CGI-I enables a clinician to assess the extent to which the severity of a patient's illness has improved or worsened relative to the baseline assessment. Improvement is assessed on a 7-point scale ranging from very much improved to very much worsened.
Change in general well-being 3 weeks before intervention; 1 and 12 weeks after intervention General well-being will be measured with the Quality of Life - Questionnaire (QoL-Q). This questionnaire consist of four subscales: satisfaction, competence or productivity, empowerment or independence, and social belonging or community integration, which result in an overall quality of life score. Each subscale contains 10 items, scored on a 3-point scale ranging from not satisfied to very satisfied. Higher scores indicate higher subjective quality of life. Completion time is about 5 minutes.
Change in experienced stress 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 Experienced stress will be measured by the Perceived Stress Scale-10 (PSS-10) that assess the degree to which individuals find their lives unpredictable, uncontrollable, and overloading. The 10 items are answered on a 5-point scale ranging from never to very often. Completion time is about 3 minutes.
Change in working memory capacity 3 weeks before intervention; 1 week after intervention Working memory capacity is assessed using the turning figures task of the Alloway Working Memory Assessment (AWMA-2). The task is administered before and after treatment completion. The completion of these task takes about 10 minutes.
Trial Locations
- Locations (1)
Karakter kinder- en jeugdpsychiatrie
🇳🇱Nijmegen, Gelderland, Netherlands