Child, OnlyHTCNCT05319002
Effects of a Group EMDR Intervention on Narrative Complexity and Specificity of Autobiographical Memories: the Hug the Child Study (HTC)
A study testing Group EMDR in people with Child, Only and Narration, run by University of Pisa at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Only, Narration, Memory Dysfunction
- What is being tested?
- Group EMDR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteItaly
- Study dates
- 20 Aug 2021to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Concurrent enrollment in other intervention trials
- Child regularly practices EMDR intervention, or other therapeutical interventions, such as cognitive behavioral therapy or meditation.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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.
- Being tested
- Group EMDR
- Keywords
- Child, EMDR, Narrative complexity, Autobiographical memories, Distress, Cognition
- Medical subject headings
- Narration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group EMDRBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group EMDR | Experimental | Participants in the experimental group will undergo a 3-week group EMDR intervention with weekly 60-minute group sessions. Receives: Behavioral: Group EMDR |
| Control | No intervention | The control group will follow routine daily school activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event coding - Pre-intervention
Event coding is measured using Manual for Coding Events in Self Defining Memories. "Relationship" nominal score means a better outcome
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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 using Coding System for Autobiographical Memory Narratives in Psychotherapy. "Autobiographic" nominal score means a better outcome.
Measured: 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
Measured: 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.
Measured: 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
Measured: Memory integration level is measured after the 3-week group EMDR intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start20 Aug 2021
- Primary completion31 Oct 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child, OnlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Poli, University of Pisa
- Investigators
- Andrea Poli, Psy.D., Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319002
- Sponsor's protocol ID
- HTC-01
- Acronym
- HTC
- Status last verified
- Mar 2022
- First submitted
- 22 Mar 2022
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data are available on request.
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.
PubMed 35805348
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05319002
- Acronym / sponsor ID
- HTC / HTC-01
- Keywords
- Child, EMDR, Narrative complexity, Autobiographical memories, Distress, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group EMDR | Experimental | Behavioral: Group EMDRParticipants in the experimental group will undergo a 3-week group EMDR intervention with weekly 60-minute group sessions. |
| Control | No intervention | –The control group will follow routine daily school activities |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Concurrent enrollment in other intervention trials
- Child regularly practices EMDR intervention, or other therapeutical interventions, such as cognitive behavioral therapy or meditation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group EMDRThe 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. | Behavioural | Group EMDR |
Primary outcome
Event coding - Pre-intervention
Time frame: Event coding is measured before the 3-week group EMDR intervention
Event coding is measured using Manual for Coding Events in Self Defining Memories. "Relationship" nominal score means a better outcome
Memory specificity level - Pre-intervention
Time frame: Memory specificity level is measured before the 3-week group EMDR intervention
Memory specificity level is measured using Classification System and Scoring for Self-defining Autobiographical Memories. "Specific" nominal score means a better outcome
Narrative complexity level - Pre-intervention
Time frame: Narrative complexity level is measured before the 3-week group EMDR intervention
Narrative complexity level is measured using Coding System for autobiographical Memory Narratives in Psychotherapy. Higher scores mean a better outcome.
Subjective Unit of Distress - Pre-intervention
Time frame: Subjective Unit of Distress is measured before the 3-week group EMDR 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
Validity of Cognition - Pre-intervention
Time frame: Validity of Cognition is measured before the 3-week group EMDR 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
Event coding - Post-intervention
Time frame: Event coding is measured after the 3-week group EMDR intervention
Event coding is measured using Manual for Coding Events in Self Defining Memories. "Relationship" nominal score means a better outcome
Memory specificity level - Post-intervention
Time frame: Memory specificity level is measured after the 3-week group EMDR intervention
Memory specificity level is measured using Classification System and Scoring for Self-defining Autobiographical Memories. "Specific" nominal score means a better outcome
Narrative complexity level - Post-intervention
Time frame: Narrative complexity level is measured after the 3-week group EMDR intervention
Narrative complexity level is measured using Coding System for autobiographical Memory Narratives in Psychotherapy. Higher scores mean a better outcome.
Subjective Unit of Distress - Post-intervention
Time frame: Subjective Unit of Distress is measured after the 3-week group EMDR 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
Validity of Cognition - Post-intervention
Time frame: Validity of Cognition is measured after the 3-week group EMDR 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
4 secondary outcomes
Autobiographical memory definition - Pre-intervention
Time frame: Autobiographical memory definition is measured before the 3-week group EMDR intervention
Memory integration level - Pre-intervention
Time frame: Memory integration level is measured before the 3-week group EMDR intervention
Autobiographical memory definition - Post-intervention
Time frame: Autobiographical memory definition is measured after the 3-week group EMDR intervention
Memory integration level - Post-intervention
Time frame: Memory integration level is measured after the 3-week group EMDR intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Derived from this study: PubMed 35805348Poli 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.
- Individual participant dataSharing planned: Yes. Raw data are available on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Poli, Psy.D. principal investigator
University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group EMDR in people with Child, Only and Narration, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event coding - Pre-intervention (time frame: Event coding is measured before the 3-week group EMDR intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05319002, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.