- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07590778
EMDR Therapy in Preterm-Born Infants With Post-Traumatic Stress Symptoms (EMDR-INFANTS)
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.
Přehled studie
Postavení
Detailní popis
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 studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Utrecht
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Utrecht, Utrecht, Holandsko
- St. Antonius Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Child post-traumatic stress symptoms
Časové okno: 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).
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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).
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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).
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Child emotional functioning
Časové okno: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
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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.
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Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
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Sleep disturbance in child
Časové okno: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
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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.
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Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
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Parental post-traumatic stress symptoms
Časové okno: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
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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.
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Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
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Parent-child bonding and interaction quality
Časové okno: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
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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.
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Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
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Child post-traumatic stress symptoms
Časové okno: Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
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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.
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Baseline, 14 days post-baseline, 14 days post-intervention and 3-month post-intervention.
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Carlijn de Roos, PhD, Levvel, Academic Center for Child and Adolescent Psychiatry, Amsterdam, the Netherlands
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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- Porodnické porodní komplikace
- Těhotenské komplikace
- Předčasný porod
- Terapie chování
- Psychoterapie
- Disciplíny a činnosti chování
- Desenzibilizace, psychologická
- Přepracování desenzibilizace pohybu očí
Další identifikační čísla studie
- R&D/Z23.098
- W23.234 (Jiný identifikátor: Medical Research Ethics Committees United (MEC-U))
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Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
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