EMDR Therapy in Preterm-Born Infants With Post-Traumatic Stress Symptoms

NCT07590778 | Completed

• 2 other identifiers: R&D/Z23.098W23.234
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Preterm Infant; Post Traumatic Stress Symptoms

Keywords

preterm infant; post traumatic stress symptoms; medical trauma; Eye Movement Desensitization and Reprocessing; early childhood; Single Case Experimental Design; early intervention

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.

• Sleep disturbance in child

  Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.

• Parental post-traumatic stress symptoms

  Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.

• Parent-child bonding and interaction quality

  Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.

• Child post-traumatic stress symptoms

  Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.

Study Arms (1)

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.

Behavioral: Eye Movement Desensitization and Reprocessing (EMDR) storytelling method

Interventions

Eye Movement Desensitization and Reprocessing (EMDR) storytelling method BEHAVIORAL

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.

EMDR storytelling intervention

Eligibility Criteria

• Age: 0 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanja Holtackers: lead
• St. Antonius Hospital: collaborator

Study Sites (1)

St. Antonius Hospital

Utrecht, Utrecht, Netherlands

Location

Related Publications (7)

• 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.

  PMID: 32027683 BACKGROUND

• Lieberman 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.

  PMID: 19486846 BACKGROUND

• Wizansky, 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 34487289 BACKGROUND

• Nix, 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

• 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.

  PMID: 28236329 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Carlijn de Roos, PhD

  Levvel, Academic Center for Child and Adolescent Psychiatry, Amsterdam, the Netherlands

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Psychologist in Training

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 15, 2026
• Study Start: February 26, 2025
• Primary Completion: January 31, 2026
• Study Completion: February 1, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)