The primary outcome measures symptom severity in parents undergoing brief treatment for PTSD.
Parents of children with chronic or acute medical conditions may experience increased PTSD symptoms due to accumulated stress.
Brief EMDR treatment is being compared to a waitlist control group to evaluate its effectiveness in reducing PTSD symptoms.
Secondary outcomes include the assessment of psychological comorbidities, parenting stress, the child's posttraumatic stress, and relationship quality.
Feasibility of delivering EMDR treatment in-person or online will also be evaluated.
Follow-up measurements will occur at two weeks, three months, and six months post-treatment to gauge symptom changes.
Simplified
BACKGROUND: Chronic or acute medical conditions greatly impact the diagnosed child and their parents. Parents have to deal with an accumulation of stressful and potential traumatic events, which can lead to post-traumatic stress symptoms (PTSS) or post-traumatic stress disorder (). A first-choice evidence-based treatment for PTSD is Eye Movement Desensitization and Reprocessing (), usually delivered in multiple sessions over weeks or months. Currently, parents do not receive this treatment due to barriers, such as time constraints, limited focus on own wellbeing, and lack of reimbursed care at children hospitals. We will study the effect of brief EMDR treatment (offered in-person or online, compared to waitlist control) in reducing PTSD symptoms and comorbid symptoms.
METHODS: In this three-armed parallel randomized controlled trial, parents start with an eligibility assessment (Tscreen), including meeting at least one of the following criteria: increased score on one symptom in each PTSD cluster, fulfillment of three of the four PTSD criteria, or total score >24 on the PCL-5. After baseline measurement (T0), eligible parents will be randomized into one of three groups: EMDR in-person (EMDRip), remote EMDR (EMDRr), or a control group (waiting list). Parents assigned to EMDRip and EMDRr will immediately start brief EMDR treatment and complete follow-up measurements at two weeks (T1ip/T1r), three months (T2ip/T2r), and six months post-treatment (T3ip/T3r). Parents in the waiting list condition complete follow-up measurements at six weeks (T1c) and 16 weeks (T2c) post baseline, assessment timepoints for the waitlist correspond to those of the intervention groups, and will be re-randomized to EMDRip or EMDRr after T2c. They will complete follow-up questionnaires at two weeks (T1.1c) and three months (T2.1c) post-treatment. Primary outcome is PTSD symptom severity. Secondary outcomes include psychological comorbidities, parenting stress, the child's posttraumatic stress, and relationship quality (parent-spouse and parent-child). Additional objectives include assessing the feasibility of EMDRip and EMDRr, as well as exploring traumatic experiences and flash forward as treatment targets.
DISCUSSION: If brief EMDR treatment is found to be effective for parents of children with a chronic or acute medical condition the implementation of screening and treatment for parents should be integrated in clinical practice.
TRIAL REGISTRATION: clinicaltrials.gov (NCT06776744), registered on January 14th, 2025. https://clinicaltrials.gov/study/NCT06776744.
Key numbers
20
Participants per group
Total of 60 parents will be enrolled across three groups.
18.9%
PTSS prevalence
Average of parents meeting criteria in similar studies.
α =.94
PCL-5 reliability
PCL-5 shows strong internal consistency in assessing .
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Declarations. Ethics approval and consent to participate: The EMpower Parents study has received approval and permission to conduct this study by the medical ethics committee of Amsterdam UMC on the 2nd of December 2024 [NL85854.018.24]. Parents sign an electronic consent form prior to the screening questionnaire (Tscreen) and for the full study and intervention (T0). This study will be conducted according to the principles of the Declaration of Helsinki revision 2013, the Dutch Medical Research Involving Human Subjects Act (WMO), the General Data Protection Regulation (GDPR), and other local guidelines, regulations and ACTS. Participation entails negligible risks for the parents. No SAEs are expected, if SAEs occur they will be reported on a yearly basis via linelisting. Participants can contact the research team for additional (psychological) support, if needed, during the study period. All protocol amendments will be reported to the medical ethics committee of Amsterdam UMC and documented in the trail registration [NCT06776744]. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.
