The Efficacy of EMDR in Youngsters With Autism

NCT03467464 | Unknown

• 1 other identifier: NL6002609116
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism, EMDR; Children

Outcome Measures

Primary Outcomes (3)

• Change in autism symptoms

  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.

  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

  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 weeks before intervention; 1 week after intervention

• Change in autism symptoms

  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.

  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 (5)

• Change in disease severity

  3 weeks before intervention; 1 and 12 weeks after intervention

• 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

• Change in general well-being

  3 weeks before intervention; 1 and 12 weeks after intervention

• Change in working memory capacity

  3 weeks before intervention; 1 week after intervention

• Change in working memory capacity

  3 weeks before intervention; 1 week after intervention

Study Arms (1)

Intervention

EXPERIMENTAL

EMDR treatment

Other: Eye Movement Desensitization and Reprocessing (EMDR)

Interventions

Eye Movement Desensitization and Reprocessing (EMDR) OTHER

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.

Intervention

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Karakter Kinder- en Jeugdpsychiatrie: lead
• Fonds Psychische Gezondheid: collaborator

Study Sites (1)

Karakter kinder- en jeugdpsychiatrie

Nijmegen, Gelderland, 6525 GC, Netherlands

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Martine Van Dongen-Boomsma, PhD

  Karakter Child and Adolescent Psychiatry University Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esther Leuning, Msc

CONTACT

0031 621902722; e.leuning@karakter.com

Aleksandra Berezowska, PhD

CONTACT

a.berezowska@karakter.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: March 16, 2018
• Study Start: December 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 16, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)