The Efficacy of EMDR in Youngsters With Autism

NCT ID: NCT03467464

Last Updated: 2018-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2018-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

EMDR treatment

Group Type: EXPERIMENTAL

Eye Movement Desensitization and Reprocessing (EMDR)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fonds Psychische Gezondheid

OTHER

Sponsor Role: collaborator

Karakter Kinder- en Jeugdpsychiatrie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martine Van Dongen-Boomsma, PhD

Role: PRINCIPAL_INVESTIGATOR

Karakter Child and Adolescent Psychiatry University Centre

Locations

Karakter kinder- en jeugdpsychiatrie

Nijmegen, Gelderland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Esther Leuning, Msc

Role: CONTACT

e.leuning@karakter.com

0031 621902722

Aleksandra Berezowska, PhD

Role: CONTACT

a.berezowska@karakter.com

Facility Contacts

Esther Leuning, Msc

Role: primary

e.leuning@karakter.com

0031 621902722

Aleksandra Berezowska, PhD

Role: backup

a.berezowska@karakter.com

Other Identifiers

NL6002609116

Identifier Type: -

Identifier Source: org_study_id