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

8 maja 2026 zaktualizowane przez: Tanja Holtackers

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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

10

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Holandia
    • Utrecht
      • Utrecht, Utrecht, Holandia
        • St. Antonius Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: EMDR storytelling intervention
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.
Behawioralne: Eye Movement Desensitization and Reprocessing (EMDR) storytelling method
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Child post-traumatic stress symptoms
Ramy czasowe: 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).
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).

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Child emotional functioning
Ramy czasowe: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
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.
Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Sleep disturbance in child
Ramy czasowe: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
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.
Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Parental post-traumatic stress symptoms
Ramy czasowe: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
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.
Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Parent-child bonding and interaction quality
Ramy czasowe: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
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.
Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
Child post-traumatic stress symptoms
Ramy czasowe: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
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.
Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Tanja Holtackers

Współpracownicy

St. Antonius Hospital

Śledczy

  • Krzesło do nauki: Carlijn de Roos, PhD, Levvel, Academic Center for Child and Adolescent Psychiatry, Amsterdam, the Netherlands

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

26 lutego 2025

Zakończenie podstawowe (Rzeczywisty)

31 stycznia 2026

Ukończenie studiów (Rzeczywisty)

1 lutego 2026

Daty rejestracji na studia

Pierwszy przesłany

20 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 maja 2026

Pierwszy wysłany (Rzeczywisty)

15 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

15 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • R&D/Z23.098
  • W23.234 (Inny identyfikator: Medical Research Ethics Committees United (MEC-U))

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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