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Trial record 9 of 257 for:    Recruiting, Not yet recruiting, Available Studies | "Autistic Disorder"

The Efficacy of EMDR in Youngsters With Autism (EYE-catcher)

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ClinicalTrials.gov Identifier: NCT03467464
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : March 16, 2018
Sponsor:
Collaborator:
Fonds Psychische Gezondheid
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Other: Eye Movement Desensitization and Reprocessing (EMDR) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of EMDR in Youngsters With Autism: an Explorative Study
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
EMDR treatment
Other: Eye Movement Desensitization and Reprocessing (EMDR)
The intervention consists of 10 weekly EMDR sessions of 60 minutes and targets stressful daily life (i.e. a situation that caused anger, fear or confusion) events rather than traumatic images from the past. For each session, a standardised EMDR protocol is used that consists of the following consecutive steps: 1) determining and visualising a confusing and/or stressful daily life event that occurred during the past week; 2) formulating a negative and a positive thought based on the chosen event; 3) determining the amount of stress that is evoked by the chosen event; 4) patient focuses on the chosen event while being presented with a distracting stimulus; 5) evaluating the amount of stress that is caused by the chosen event; 6) linking positive thoughts to the negative one when the stress caused by the chosen event does no longer exist; 7) evaluation and closure of session.




Primary Outcome Measures :
  1. Change in autism symptoms [ Time Frame: 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 ]
    Change in autism symptoms is assessed with the SRS-A, which measures youngsters' ability to engage in reciprocal social behaviour in natural social settings, among all domains of autistic symptoms. The SRS-A consist of 5 subscales: 1) Social Awareness, 2) Social Cognition, 3) Social Communication 4) Social Motivation, and 5) Autistic Mannerisms. In total the five subscales comprise 65-items that are answered on a 4-point scale ranging from never true to almost always true. Completion of the questionnaire takes about 15 minutes. The SRS-A is completed by both parents and youngsters separately. Considering that SRS-A scores provided by youngsters are likely to be less reliable, the total score of the parents will serve as the primary outcome measure. In a secondary analysis, the total score of the youngsters will be used to determine the extent to which they perceive EMDR as an effective treatment.

  2. Change in autism symptoms [ Time Frame: 3 weeks before intervention; 1 week after intervention ]
    Using the Autism Diagnostic Observation Schedule 2 (ADOS 2) changes in autism symptoms prior to and after treatment will be assessed. The ADOS is administered by observing the youngster during a semi-structured observation schedule. With the ADOS, the clinician elicits social, communicative, stereotyped and play behavior to observe symptoms of ASD. Activities are performed with a 40 to 60 minutes protocol. Observations of the clinician are categorized and a score is assigned for each domain of ASD symptoms. Total scores on the ADOS are compared pre-treatment and post-treatment.

  3. Change in autism symptoms [ Time Frame: 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 :
  1. Change in disease severity [ Time Frame: 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.

  2. Change in experienced stress [ Time Frame: 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.

  3. Change in general well-being [ Time Frame: 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.

  4. Change in working memory capacity [ Time Frame: 3 weeks before intervention; 1 week after intervention ]
    Working memory capacity is assessed using the letters mix 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.

  5. Change in working memory capacity [ Time Frame: 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.



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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467464


Contacts
Contact: Esther Leuning, Msc 0031 621902722 e.leuning@karakter.com
Contact: Aleksandra Berezowska, PhD a.berezowska@karakter.com

Locations
Netherlands
Karakter kinder- en jeugdpsychiatrie Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GC
Contact: Esther Leuning, Msc    0031 621902722    e.leuning@karakter.com   
Contact: Aleksandra Berezowska, PhD       a.berezowska@karakter.com   
Sponsors and Collaborators
Karakter Kinder- en Jeugdpsychiatrie
Fonds Psychische Gezondheid
Investigators
Principal Investigator: Martine Van Dongen-Boomsma, PhD Karakter Child and Adolescent Psychiatry University Centre

Responsible Party: Karakter Kinder- en Jeugdpsychiatrie
ClinicalTrials.gov Identifier: NCT03467464     History of Changes
Other Study ID Numbers: NL6002609116
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karakter Kinder- en Jeugdpsychiatrie:
Autism, EMDR; Children

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders