Post Traumatic Stress SymptomsEMDR-INFANTSNCT07590778
EMDR Therapy in Preterm-Born Infants With Post-Traumatic Stress Symptoms
A study testing Eye Movement Desensitization and Reprocessing (EMDR) storytelling method in people with Post Traumatic Stress Symptoms and Preterm Infant, run by Tanja Holtackers at 1 site in Netherlands.
Trial summary
This study examines a trauma-focused treatment for very young children who were born prematurely and developed post-traumatic stress related symptoms after medical care. Preterm infants often experience stressful events in the hospital, which can affect their emotional and behavioral development. Read more about this study
- Who is it for?
- Ages 0 to 24 months
- Conditions the study is for
- Post Traumatic Stress Symptoms, Preterm Infant
- What is being tested?
- Eye Movement Desensitization and Reprocessing (EMDR) storytelling method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Feb 2025to 1 Feb 2026
- 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 0 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm birth (<37 weeks gestational age)
- Age between 0 and 24 months
- Presence of frequent and severe post-traumatic stress symptoms (occurring daily to multiple times per week), considered related to medical trauma following premature birth
- Not currently hospitalized
- Availability of a parent or legal guardian able to provide informed consent
Who cannot join
- Insufficient proficiency in Dutch to complete study procedures and questionnaires
- Severe physical illness or medical condition that is considered to be the primary focus of clinical care and/or interferes with participation in the intervention
- Current participation in other trauma-focused psychological treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) in Preterm-Born Infants Aged 0-2 Years With Post-Traumatic Stress Symptoms: A Multiple Baseline Experimental Design
This study examines a trauma-focused treatment for very young children who were born prematurely and developed post-traumatic stress related symptoms after medical care. Preterm infants often experience stressful events in the hospital, which can affect their emotional and behavioral development.
In this study, an adapted form (storytelling) of Eye Movement Desensitization and Reprocessing (EMDR) therapy was used with preterm born children aged 0 to 2 years. The treatment was delivered in a small group of participants, and changes in post- traumatic stress symptoms, sleep, emotional functioning, parental PTSD symptoms and perceived bonding and parent-infant interaction were monitored over time using parent reports.
The aim of the study is to evaluate whether this early intervention (EMDR, storytelling) is feasible, well accepted by families, and potentially effective in reducing post-traumatic stress related symptoms in this vulnerable population.
Read the detailed description
Preterm birth exposes infants to repeated medical stressors during a critical period of development. These stressors may include invasive procedures, high levels of sensory stimulation, and separation from caregivers. Such early experiences can lead to post-traumatic stress symptoms, including excessive crying, sleep and feeding difficulties, heightened arousal, and problems with emotional regulation and parent-infant interaction and perceived bonding.
Evidence-based trauma-focused interventions for children under the age of two years are limited. Eye Movement Desensitization and Reprocessing (EMDR) is an established trauma-focused treatment in older children and adults, but its application in very young children is still emerging. The EMDR storytelling method is a developmentally adapted approach designed for use with infants and toddlers, involving active caregiver participation.
The aim of this study was to evaluate the feasibility, acceptability, and preliminary effectiveness of the EMDR storytelling method in preterm-born children aged 0 to 2 years with post-traumatic stress symptoms following medical experiences.
A non-concurrent multiple-baseline single-case experimental design was conducted, including 10 participants. Daily individualized trauma-related symptoms were monitored across baseline, intervention, post-intervention, and 3-month follow-up phases. In addition, standardized parent-reported questionnaires were used to assess child emotional and behavioral functioning, sleep problems, parent-child interaction, bonding difficulties, and parental post-traumatic stress symptoms at multiple time points.
Participants received up to six EMDR sessions of approximately one hour each.
The study was retrospectively registered.
The findings suggest that the intervention was feasible and acceptable in this sample, with no drop-out and no adverse events reported. Reductions in post-traumatic stress symptoms were observed in most participants following the intervention and were maintained at follow-up. Improvements were also observed in child emotional functioning, sleep, parent-child interaction, and parental stress symptoms.
These findings should be interpreted with caution given the small sample size and study design. Further research using controlled study designs is needed to confirm these results.
- Conditions
- Post Traumatic Stress Symptoms, Preterm Infant
- Being tested
- Eye Movement Desensitization and Reprocessing (EMDR) storytelling method
- Keywords
- preterm infant, post traumatic stress symptoms, medical trauma, Eye Movement Desensitization and Reprocessing, early childhood, Single Case Experimental Design, early intervention
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Movement Desensitization and Reprocessing (EMDR) storytelling methodBehavioural
The EMDR storytelling method is a developmentally adapted trauma-focused intervention based on Eye Movement Desensitization and Reprocessing (EMDR). The treatment is designed for infants and toddlers (in preverbal period) and involves caregiver participation. A structured storytelling approach is used to process traumatic medical experiences. Participants received up to six individual sessions of approximately one hour each.
| Study group | Role | What they receive |
|---|---|---|
| EMDR storytelling intervention | Experimental | Participants were preterm-born infants aged 0-2 years presenting with post-traumatic stress symptoms following medical experiences. All participants received the EMDR storytelling intervention, a developmentally adapted trauma-focused treatment involving caregiver participation. The intervention was delivered individually in up to six sessions of approximately one hour each. Outcomes were assessed across baseline, intervention, post-intervention, and 3-month follow-up phases. Receives: Behavioral: Eye Movement Desensitization and Reprocessing (EMDR) storytelling method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child post-traumatic stress symptoms
Daily idiosyncratic post-traumatic stress symptoms in preterm-born infants aged 0-2 years, assessed across baseline, intervention, post-intervention, and 3-month post-intervention phases. Symptoms were monitored using caregiver-reported daily ratings specific to each child's trauma-related stress responses (scale 0-100, higher scores indicate worse symptoms).
Measured: Daily during baseline (minimum 14 days) through intervention (minimum 14 days up to 49 days) and post-intervention (minimum 14 days), and at 3-month post-intervention phase (14 days).
Secondary outcomes (5)
Child emotional functioning
Parent-reported measures of child emotional and behavioral functioning in preterm-born infants exposed to medical trauma. Assessed using standardized questionnaires: depressive symptoms (8 items; range 8-40), and anxiety (8 items; range 8-40) scales from the Dutch translation of the PROMIS Early Childhood Parent Report. Higher scores indicate worse symptoms.
Measured: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Sleep disturbance in child
Parent-reported sleep problems in preterm infants measured using standardized sleep-related questionnaire: The Dutch translation of the PROMIS Early Childhood Parent Report: sleep disturbances scale (4 items; range 4-20). Higher scores indicate worse symptoms.
Measured: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Parental post-traumatic stress symptoms
Self-reported parental symptoms of post-traumatic stress related to the child's medical history, assessed with a validated questionnaire: The Dutch translation of the PCL-5. Total scores (range 0-80) were used to examine changes in PTSD symptoms in parents. Higher scores indicate a higher degree of PTSD symptoms.
Measured: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Parent-child bonding and interaction quality
Parent-reported bonding difficulties and quality of interaction between caregiver and child following medical trauma. Measured by using the standardized questionnaire: Dutch translation of the Post-partum Bonding Questionnaire (PBQ). The total score (range 0-125) is used , with higher scores indicating worse symptoms. And measured by the standardized questionnaire: The Dutch translation of the PROMIS Early Childhood Parent Report: Scale Child-caregiver interaction was assessed using a 5-item scale (range 5-25). Higher scores indicate improvement of symptoms.
Measured: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Child post-traumatic stress symptoms
Parent-reported measures of child post-traumatic stress symptoms in preterm-born infants exposed to medical trauma. Assessed using the standardized questionnaire: The Dutch translation of the Child and Adolescent Trauma Screener (CATS). Range 0-45, higher scores indicate worse symptoms.
Measured: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start26 Feb 2025
- Primary completion31 Jan 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress SymptomsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanja Holtackers
- Sponsor type
- University, hospital or other
- Collaborators
- St. Antonius Hospital
- Responsible party
- Sponsor-investigator, Tanja Holtackers, St. Antonius Hospital
- Investigators
- Carlijn de Roos, PhD, Study chair, Levvel, Academic Center for Child and Adolescent Psychiatry, Amsterdam, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590778
- Sponsor's protocol ID
- R&D/Z23.098
- Other IDs
- W23.234
- Acronym
- EMDR-INFANTS
- Status last verified
- May 2026
- First submitted
- 20 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the General Data Protection Regulation (GDPR), the European privacy legislation applicable in this study, raw data may not be shared with other parties.
Publications
Bouwmeester S, Jongerling J. Power of a randomization test in a single case multiple baseline AB design. PLoS One. 2020 Feb 6;15(2):e0228355. doi: 10.1371/journal.pone.0228355. eCollection 2020.
PubMed 32027683Lieberman AF, Van Horn P. Giving voice to the unsayable: repairing the effects of trauma in infancy and early childhood. Child Adolesc Psychiatr Clin N Am. 2009 Jul;18(3):707-20. doi: 10.1016/j.chc.2009.02.007.
PubMed 19486846Wizansky, B., & Bar Sadeh, E. (2021). Dyadic EMDR: A clinical model for the treatment of preverbal medical trauma. Journal of Infant, Child, and Adolescent Psychotherapy, 20(3), 260-276. https://doi.org/10.1080/15289168.2021.1940661
Tate, R. L., Perdices, M., Rosenkoetter, U., McDonald, S., Togher, L., Shadish, W., Horner, R., Kratochwill, T., Barlow, D. H., Kazdin, A., Sampson, M., Shamseer, L., & Vohra, S. (2016). The Single-Case Reporting in Behavioural Interventions (SCRIBE) 2016: Explanation and elaboration. Archives of Scientific Psychology, 4(1), 10-31. https://doi.org/10.1037/arc0000027
Olivier E, de Roos C, Bexkens A. Eye Movement Desensitization and Reprocessing in Young Children (Ages 4-8) with Posttraumatic Stress Disorder: A Multiple-Baseline Evaluation. Child Psychiatry Hum Dev. 2022 Dec;53(6):1391-1404. doi: 10.1007/s10578-021-01237-z. Epub 2021 Sep 6.
PubMed 34487289Nix, C. M., & Ansermet, F. (2009). Prematurity, risk factors, and protective factors. In C. H. Zeanah (Ed.), Handbook of infant mental health (3rd ed., pp. 180-196). Guilford Press.
D'Agata AL, Sanders MR, Grasso DJ, Young EE, Cong X, Mcgrath JM. UNPACKING THE BURDEN OF CARE FOR INFANTS IN THE NICU. Infant Ment Health J. 2017 Mar;38(2):306-317. doi: 10.1002/imhj.21636. Epub 2017 Feb 25.
PubMed 28236329
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) in Preterm-Born Infants Aged 0-2 Years With Post-Traumatic Stress Symptoms: A Multiple Baseline Experimental Design
- ClinicalTrials.gov ID
- NCT07590778
- Acronym / sponsor ID
- EMDR-INFANTS / R&D/Z23.098
- Conditions
- Post Traumatic Stress Symptoms, Preterm Infant
- Keywords
- preterm infant, post traumatic stress symptoms, medical trauma, Eye Movement Desensitization and Reprocessing, early childhood, Single Case Experimental Design, early intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tanja HoltackersUniversity, hospital or other
- Collaborators
- St. Antonius Hospital
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 15 May 2026 (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.
This study examines a trauma-focused treatment for very young children who were born prematurely and developed post-traumatic stress related symptoms after medical care. Preterm infants often experience stressful events in the hospital, which can affect their emotional and behavioral development.
In this study, an adapted form (storytelling) of Eye Movement Desensitization and Reprocessing (EMDR) therapy was used with preterm born children aged 0 to 2 years. The treatment was delivered in a small group of participants, and changes in post- traumatic stress symptoms, sleep, emotional functioning, parental PTSD symptoms and perceived bonding and parent-infant interaction were monitored over time using parent reports.
The aim of the study is to evaluate whether this early intervention (EMDR, storytelling) is feasible, well accepted by families, and potentially effective in reducing post-traumatic stress related symptoms in this vulnerable population.
Detailed description
Preterm birth exposes infants to repeated medical stressors during a critical period of development. These stressors may include invasive procedures, high levels of sensory stimulation, and separation from caregivers. Such early experiences can lead to post-traumatic stress symptoms, including excessive crying, sleep and feeding difficulties, heightened arousal, and problems with emotional regulation and parent-infant interaction and perceived bonding.
Evidence-based trauma-focused interventions for children under the age of two years are limited. Eye Movement Desensitization and Reprocessing (EMDR) is an established trauma-focused treatment in older children and adults, but its application in very young children is still emerging. The EMDR storytelling method is a developmentally adapted approach designed for use with infants and toddlers, involving active caregiver participation.
The aim of this study was to evaluate the feasibility, acceptability, and preliminary effectiveness of the EMDR storytelling method in preterm-born children aged 0 to 2 years with post-traumatic stress symptoms following medical experiences.
A non-concurrent multiple-baseline single-case experimental design was conducted, including 10 participants. Daily individualized trauma-related symptoms were monitored across baseline, intervention, post-intervention, and 3-month follow-up phases. In addition, standardized parent-reported questionnaires were used to assess child emotional and behavioral functioning, sleep problems, parent-child interaction, bonding difficulties, and parental post-traumatic stress symptoms at multiple time points.
Participants received up to six EMDR sessions of approximately one hour each.
The study was retrospectively registered.
The findings suggest that the intervention was feasible and acceptable in this sample, with no drop-out and no adverse events reported. Reductions in post-traumatic stress symptoms were observed in most participants following the intervention and were maintained at follow-up. Improvements were also observed in child emotional functioning, sleep, parent-child interaction, and parental stress symptoms.
These findings should be interpreted with caution given the small sample size and study design. Further research using controlled study designs is needed to confirm these results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMDR storytelling intervention | Experimental | Behavioral: Eye Movement Desensitization and Reprocessing (EMDR) storytelling methodParticipants were preterm-born infants aged 0-2 years presenting with post-traumatic stress symptoms following medical experiences. All participants received the EMDR storytelling intervention, a developmentally adapted trauma-focused treatment involving caregiver participation. The intervention was delivered individually in up to six sessions of approximately one hour each. Outcomes were assessed across baseline, intervention, post-intervention, and 3-month follow-up phases. |
Who may qualify
- Ages
- 0 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Preterm birth (<37 weeks gestational age)
- Age between 0 and 24 months
- Presence of frequent and severe post-traumatic stress symptoms (occurring daily to multiple times per week), considered related to medical trauma following premature birth
- Not currently hospitalized
- Availability of a parent or legal guardian able to provide informed consent
Key exclusion criteria (3 listed)
- Insufficient proficiency in Dutch to complete study procedures and questionnaires
- Severe physical illness or medical condition that is considered to be the primary focus of clinical care and/or interferes with participation in the intervention
- Current participation in other trauma-focused psychological treatment
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 |
|---|---|---|
| Eye Movement Desensitization and Reprocessing (EMDR) storytelling methodThe EMDR storytelling method is a developmentally adapted trauma-focused intervention based on Eye Movement Desensitization and Reprocessing (EMDR). The treatment is designed for infants and toddlers (in preverbal period) and involves caregiver participation. A structured storytelling approach is used to process traumatic medical experiences. Participants received up to six individual sessions of approximately one hour each. | Behavioural | EMDR storytelling intervention |
Primary outcome
Child post-traumatic stress symptoms
Time frame: Daily during baseline (minimum 14 days) through intervention (minimum 14 days up to 49 days) and post-intervention (minimum 14 days), and at 3-month post-intervention phase (14 days).
Daily idiosyncratic post-traumatic stress symptoms in preterm-born infants aged 0-2 years, assessed across baseline, intervention, post-intervention, and 3-month post-intervention phases. Symptoms were monitored using caregiver-reported daily ratings specific to each child's trauma-related stress responses (scale 0-100, higher scores indicate worse symptoms).
5 secondary outcomes
Child emotional functioning
Time frame: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Sleep disturbance in child
Time frame: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Parental post-traumatic stress symptoms
Time frame: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Parent-child bonding and interaction quality
Time frame: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Child post-traumatic stress symptoms
Time frame: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-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 15 May 2026.
- Background: PubMed 32027683Bouwmeester S, Jongerling J. Power of a randomization test in a single case multiple baseline AB design. PLoS One. 2020 Feb 6;15(2):e0228355. doi: 10.1371/journal.pone.0228355. eCollection 2020.
- Background: PubMed 19486846Lieberman AF, Van Horn P. Giving voice to the unsayable: repairing the effects of trauma in infancy and early childhood. Child Adolesc Psychiatr Clin N Am. 2009 Jul;18(3):707-20. doi: 10.1016/j.chc.2009.02.007.
- BackgroundWizansky, B., & Bar Sadeh, E. (2021). Dyadic EMDR: A clinical model for the treatment of preverbal medical trauma. Journal of Infant, Child, and Adolescent Psychotherapy, 20(3), 260-276. https://doi.org/10.1080/15289168.2021.1940661
- BackgroundTate, R. L., Perdices, M., Rosenkoetter, U., McDonald, S., Togher, L., Shadish, W., Horner, R., Kratochwill, T., Barlow, D. H., Kazdin, A., Sampson, M., Shamseer, L., & Vohra, S. (2016). The Single-Case Reporting in Behavioural Interventions (SCRIBE) 2016: Explanation and elaboration. Archives of Scientific Psychology, 4(1), 10-31. https://doi.org/10.1037/arc0000027
- Background: PubMed 34487289Olivier E, de Roos C, Bexkens A. Eye Movement Desensitization and Reprocessing in Young Children (Ages 4-8) with Posttraumatic Stress Disorder: A Multiple-Baseline Evaluation. Child Psychiatry Hum Dev. 2022 Dec;53(6):1391-1404. doi: 10.1007/s10578-021-01237-z. Epub 2021 Sep 6.
- BackgroundNix, C. M., & Ansermet, F. (2009). Prematurity, risk factors, and protective factors. In C. H. Zeanah (Ed.), Handbook of infant mental health (3rd ed., pp. 180-196). Guilford Press.
- Background: PubMed 28236329D'Agata AL, Sanders MR, Grasso DJ, Young EE, Cong X, Mcgrath JM. UNPACKING THE BURDEN OF CARE FOR INFANTS IN THE NICU. Infant Ment Health J. 2017 Mar;38(2):306-317. doi: 10.1002/imhj.21636. Epub 2017 Feb 25.
- Individual participant dataSharing planned: No. Due to the General Data Protection Regulation (GDPR), the European privacy legislation applicable in this study, raw data may not be shared with other parties.
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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.
Carlijn de Roos, PhD study chair
Levvel, Academic Center for Child and Adolescent Psychiatry, Amsterdam, the Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Movement Desensitization and Reprocessing (EMDR) storytelling method in people with Post Traumatic Stress Symptoms and Preterm Infant, run by Tanja Holtackers at 1 site in Netherlands.
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 5 inclusion and 3 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 15 May 2026. 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 Netherlands. 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?
Child post-traumatic stress symptoms (time frame: Daily during baseline (minimum 14 days) through intervention (minimum 14 days up to 49 days) and post-intervention (minimum 14 days), and at 3-month post-intervention phase (14 days).). 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 NCT07590778, which also lists 7 linked publications.
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 15 May 2026.