Clinical trial NCT05319002: Effects of a Group EMDR Intervention on Narrative Complexity and Specificity of Autobiographical Memories: the Hug the Child Study (HTC)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child, Only
Narration
Memory Dysfunction
Distress, Emotional
Cognitive Change
Keywords: Child
EMDR
Narrative complexity
Autobiographical memories
Distress
Cognition
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 27
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Event coding - Pre-intervention
timeFrame: Event coding is measured before the 3-week group EMDR intervention
measure: Memory specificity level - Pre-intervention
timeFrame: Memory specificity level is measured before the 3-week group EMDR intervention
measure: Narrative complexity level - Pre-intervention
timeFrame: Narrative complexity level is measured before the 3-week group EMDR intervention
measure: Subjective Unit of Distress - Pre-intervention
timeFrame: Subjective Unit of Distress is measured before the 3-week group EMDR intervention
measure: Validity of Cognition - Pre-intervention
timeFrame: Validity of Cognition is measured before the 3-week group EMDR intervention
measure: Event coding - Post-intervention
timeFrame: Event coding is measured after the 3-week group EMDR intervention
measure: Memory specificity level - Post-intervention
timeFrame: Memory specificity level is measured after the 3-week group EMDR intervention
measure: Narrative complexity level - Post-intervention
timeFrame: Narrative complexity level is measured after the 3-week group EMDR intervention
measure: Subjective Unit of Distress - Post-intervention
timeFrame: Subjective Unit of Distress is measured after the 3-week group EMDR intervention
measure: Validity of Cognition - Post-intervention
timeFrame: Validity of Cognition is measured after the 3-week group EMDR intervention
Secondary outcomes:
measure: Autobiographical memory definition - Pre-intervention
timeFrame: Autobiographical memory definition is measured before the 3-week group EMDR intervention
measure: Memory integration level - Pre-intervention
timeFrame: Memory integration level is measured before the 3-week group EMDR intervention
measure: Autobiographical memory definition - Post-intervention
timeFrame: Autobiographical memory definition is measured after the 3-week group EMDR intervention
measure: Memory integration level - Post-intervention
timeFrame: Memory integration level is measured after the 3-week group EMDR intervention
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University of Pisa
Study officials:
affiliation: University of Pisa
name: Andrea Poli, Psy.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.