Effects of a Group EMDR Intervention on Narrative Complexity and Specificity of Autobiographical Memories: the Hug the Child Study (HTC) (HTC)

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 Approach

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Change; Child, Only; Distress, Emotional; Narration; Memory Dysfunction
• Intervention / Treatment: Behavioral: Group EMDR

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pisa, Italy, 56126
    • University of Pisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 11 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group EMDR; Participants in the experimental group will undergo a 3-week group EMDR intervention with weekly 60-minute group sessions.	Behavioral: Group EMDR; 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.
NO_INTERVENTION: Control; The control group will follow routine daily school activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autobiographical memory definition - Pre-intervention	Autobiographical memory definition is measured using Coding System for Autobiographical Memory Narratives in Psychotherapy. "Autobiographic" nominal score means a better outcome.	Autobiographical memory definition is measured before the 3-week group EMDR intervention
Memory integration level - Pre-intervention	Memory integration level is measured using Classification System and Scoring for Self-defining Autobiographical Memories. "Integrated" nominal score means a better outcome	Memory integration level is measured before the 3-week group EMDR intervention
Autobiographical memory definition - Post-intervention	Autobiographical memory definition is measured using Coding System for Autobiographical Memory Narratives in Psychotherapy. "Autobiographic" nominal score means a better outcome.	Autobiographical memory definition is measured after the 3-week group EMDR intervention
Memory integration level - Post-intervention	Memory integration level is measured using Classification System and Scoring for Self-defining Autobiographical Memories. "Integrated" nominal score means a better outcome	Memory integration level is measured after the 3-week group EMDR intervention

Collaborators and Investigators

• Sponsor: University of Pisa

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 20, 2021
• Primary Completion (ACTUAL): October 31, 2021
• Study Completion (ACTUAL): November 30, 2021

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (ACTUAL): April 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Child; Cognition; Distress; EMDR; Narrative complexity; Autobiographical memories
• Other Study ID Numbers: HTC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Raw data are available on request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No