NCT05319002

Brief Summary

Background and study aims: The Eye Movement Desensitization and Reprocessing Group Protocol with Children (EMDR-GP/C) was first developed by Korkmazlar following the Marmara earthquake in Turkey in 1999 and can be adapted for different populations. The aim of this study is to assess if a EMDR-GP program may help primary school students in improving narrative complexity and specificity of autobiographical memories, as well as their subjective unit of distress (SUD) and validity of cognition (VoC). Who can participate? Students attending the fourth or fifth year of primary school What does the study involve? Participants will be randomly assigned to the experimental and control groups. Participants in the experimental group will undergo a 3-week EMDR-GP with weekly 60-minute group sessions (3 sessions), while the control group will follow routine daily school activities. Questionnaires will be used to assess narrative complexity, specificity of autobiographical memories, SUD and VoC before and after the intervention. What are the possible benefits and risks of participating? Benefits of participating in the study may include an improvement of narrative complexity, specificity of autobiographical memories, and their SUD and VoC.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
Last Updated

April 8, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

March 22, 2022

Last Update Submit

March 31, 2022

Conditions

Keywords

ChildEMDRNarrative complexityAutobiographical memoriesDistressCognition

Outcome Measures

Primary Outcomes (10)

  • Event coding - Pre-intervention

    Event coding is measured using Manual for Coding Events in Self Defining Memories. "Relationship" nominal score means a better outcome

    Event coding is measured before the 3-week group EMDR intervention

  • Memory specificity level - Pre-intervention

    Memory specificity level is measured using Classification System and Scoring for Self-defining Autobiographical Memories. "Specific" nominal score means a better outcome

    Memory specificity level is measured before the 3-week group EMDR intervention

  • Narrative complexity level - Pre-intervention

    Narrative complexity level is measured using Coding System for autobiographical Memory Narratives in Psychotherapy. Higher scores mean a better outcome.

    Narrative complexity level is measured before the 3-week group EMDR intervention

  • Subjective Unit of Distress - Pre-intervention

    Subjective Unit of Distress is measured using a self-reporting scale with a 0- to 10-point rating scale. Higher scores mean a worse outcome

    Subjective Unit of Distress is measured before the 3-week group EMDR intervention

  • Validity of Cognition - Pre-intervention

    Validity of Cognition is measured using a self-reporting scale with a 1- to 7-point rating scale. Higher scores mean a better outcome

    Validity of Cognition is measured before the 3-week group EMDR intervention

  • Event coding - Post-intervention

    Event coding is measured using Manual for Coding Events in Self Defining Memories. "Relationship" nominal score means a better outcome

    Event coding is measured after the 3-week group EMDR intervention

  • Memory specificity level - Post-intervention

    Memory specificity level is measured using Classification System and Scoring for Self-defining Autobiographical Memories. "Specific" nominal score means a better outcome

    Memory specificity level is measured after the 3-week group EMDR intervention

  • Narrative complexity level - Post-intervention

    Narrative complexity level is measured using Coding System for autobiographical Memory Narratives in Psychotherapy. Higher scores mean a better outcome.

    Narrative complexity level is measured after the 3-week group EMDR intervention

  • Subjective Unit of Distress - Post-intervention

    Subjective Unit of Distress is measured using a self-reporting scale with a 0- to 10-point rating scale. Higher scores mean a worse outcome

    Subjective Unit of Distress is measured after the 3-week group EMDR intervention

  • Validity of Cognition - Post-intervention

    Validity of Cognition is measured using a self-reporting scale with a 1- to 7-point rating scale. Higher scores mean a better outcome

    Validity of Cognition is measured after the 3-week group EMDR intervention

Secondary Outcomes (4)

  • Autobiographical memory definition - Pre-intervention

    Autobiographical memory definition is measured before the 3-week group EMDR intervention

  • Memory integration level - Pre-intervention

    Memory integration level is measured before the 3-week group EMDR intervention

  • Autobiographical memory definition - Post-intervention

    Autobiographical memory definition is measured after the 3-week group EMDR intervention

  • Memory integration level - Post-intervention

    Memory integration level is measured after the 3-week group EMDR intervention

Study Arms (2)

Group EMDR

EXPERIMENTAL

Participants in the experimental group will undergo a 3-week group EMDR intervention with weekly 60-minute group sessions.

Behavioral: Group EMDR

Control

NO INTERVENTION

The control group will follow routine daily school activities

Interventions

Group EMDRBEHAVIORAL

The eight phases of the adapted group EMDR protocol was administered during each session: 1. Meeting: Explaining the nature of trauma, group rules, name tags, filling in the scales. 2. Preparation: Exploring children's support system, explaining EMDR, safe place, resource exercise, and installation with bilateral stimulation (BLS, butterfly hug or knee tapping). 3. Assessment: Drawing the worst image on a small separate sheet of paper, SUD level, (negative cognition, emotions, body sensations - if possible). 4. Desensitization: It is done with drawing on 4 separate papers with BLS (butterfly hug or knee tapping). 5. Installation: With the healing story written according to the adaptive information processing (AIP) model, the installation is accompanied BLS. 6. Body scan: A positive body state is installed with the relaxation technique. 7. Closure \& future template: Strong closure with artwork. 8. Re-evaluation: if possible.

Group EMDR

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 9 to 11 years
  • Children have reasonable comprehension of spoken language and can follow simple instructions
  • Children and their parents are willing to attend all intervention sessions
  • Children and parents have an adequate understanding of Italian

You may not qualify if:

  • Concurrent enrollment in other intervention trials
  • Child regularly practices EMDR intervention, or other therapeutical interventions, such as cognitive behavioral therapy or meditation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pisa

Pisa, 56126, Italy

Location

Related Publications (1)

  • Poli A, Gemignani A, Miccoli M. Randomized Trial on the Effects of a Group EMDR Intervention on Narrative Complexity and Specificity of Autobiographical Memories: A Path Analytic and Supervised Machine-Learning Study. Int J Environ Res Public Health. 2022 Jun 23;19(13):7684. doi: 10.3390/ijerph19137684.

MeSH Terms

Conditions

Narration

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Andrea Poli, Psy.D.

    University of Pisa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 22, 2022

First Posted

April 8, 2022

Study Start

August 20, 2021

Primary Completion

October 31, 2021

Study Completion

November 30, 2021

Last Updated

April 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

Raw data are available on request.

Shared Documents
STUDY PROTOCOL

Locations