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

8 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

10

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Utrecht
      • Utrecht, Utrecht, Olanda
        • St. Antonius Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Child post-traumatic stress symptoms
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Child emotional functioning
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Collaboratori

Investigatori

  • Cattedra di studio: Carlijn de Roos, PhD, Levvel, Academic Center for Child and Adolescent Psychiatry, Amsterdam, the Netherlands

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

26 febbraio 2025

Completamento primario (Effettivo)

31 gennaio 2026

Completamento dello studio (Effettivo)

1 febbraio 2026

Date di iscrizione allo studio

Primo inviato

20 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 maggio 2026

Primo Inserito (Effettivo)

15 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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