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

8. maj 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

  • Holland
    • Utrecht
      • Utrecht, Utrecht, Holland
        • St. Antonius Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Child post-traumatic stress symptoms
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Child emotional functioning
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tanja Holtackers

Samarbejdspartnere

St. Antonius Hospital

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. februar 2025

Primær færdiggørelse (Faktiske)

31. januar 2026

Studieafslutning (Faktiske)

1. februar 2026

Datoer for studieregistrering

Først indsendt

20. april 2026

Først indsendt, der opfyldte QC-kriterier

8. maj 2026

Først opslået (Faktiske)

15. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

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INGEN

IPD-planbeskrivelse

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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