EMpower Parents: Effectiveness of EMDR Treatment for Parental PTSD Related to Their Child's Medical Condition.

NCT06776744 | Not Yet Recruiting

• 1 other identifier: NL85854.018.24
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if short EMDR treatment offered in two modalities (face to face and remote) is effective in reducing PTSD symptoms and comorbid symptoms for parents of children with diverse chronic and acute medical conditions. The main question is: • Is short EMDR treatment effective in reducing PTSD symptoms in parents of children with chronic or acute medical conditions? Researchers will compare in person and remote EMDR treatment to a waiting list group to see if the treatment is effective. Participants in the intervention conditions will participate in four in person or remote EMDR sessions, each lasting 1.5 hours, spread across two half-days. Participants in the waiting list condition will receive this treatment after a period of 3 months.

Conditions

All Acute Pediatric Conditions; All Chronic Pediatric Conditions

Keywords

EMDR; Pediatrics; Posttraumatic stress; Parental PTSD; Parents; Trauma therapy; E-health

Outcome Measures

Primary Outcomes (1)

• Posttraumatic stress (symptoms) assessed with the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

  From T0 [enrolment] to T1 [2 weeks post end of treatment]

Secondary Outcomes (9)

• Psychological comorbidity - Anxiety assessed with the Dutch-Flemish PROMIS Bank v1.0 - Anxiety

  From T0 [enrolment] to T1 [2 weeks post end of treatment]

• Psychological comorbidity - Depression assessed with the Dutch-Flemish PROMIS Item Bank v1.0 - Depression

  From T0 [enrolment] to T1 [2 weeks post end of treatment]

• Psychological comorbidity - Somatization assessed with the Brief Symptom Inventory-18, BSI-18, subscale Somatic Symptoms

  From T0 [enrolment] to T1 [2 weeks post end of treatment]

• Parenting stress assessed with the Parenting Burden Questionnaire, OBVL

  From T0 [enrolment] to T1 [2 weeks post end of treatment]

• Parent-child relationship assessed with the Parenting Burden Questionnaire, OBVL

  From T0 [enrolment] to T1 [2 weeks post end of treatment]

Other Outcomes (5)

• Feasibility, self-composed questionnaire

  2 weeks post treatment follow-up (T1ip, T1r, T.1.c)

• Therapy preference, self-composed question

  Tscreen: part of the first set-of questionnaires parents complete to check for eligibility, pre-intervention.

• New traumatic experiences during treatment, self-composed question

  At every follow-up measurement moment: T1c: 6 weeks post T0 follow-up, T2c: 16 weeks post T0 follow-up, T1ip, T1r, T1.1c: 2 weeks post end of treatment, T2ip, T2r, T2.1c: 3 months post end of treatment, T3ip, T3r: 6 months post end of treatment.

Study Arms (3)

EMDR in person

EXPERIMENTAL

For both intervention conditions (EMDRip and EMDRr), short EMDR treatment, 4 x 1.5 hour divided over 2 half-days, will be offered following the standard eight-phase protocol (14). Parents in the EMDRip condition will receive EMDR treatment at the Emma Children's Hospital.

Other: Eye Movement Desensitization and Reprocessing (EMDR)

EMDR remote

EXPERIMENTAL

For both intervention conditions (EMDRip and EMDRr), short EMDR treatment, 4 x 1.5 hour divided over 2 half-days, will be offered following the standard eight-phase protocol (14). Parents in the EMDRr condition will receive EMDR treatment remote via the online web-based tool EMDR platform.

Other: Eye Movement Desensitization and Reprocessing (EMDR)

Waiting list

NO INTERVENTION

Interventions

Eye Movement Desensitization and Reprocessing (EMDR) OTHER

Eye Movement Desensitization and Reprocessing (EMDR) treatment. EMDR is one of the first-choice evidence based treatments for PTSD. During an EMDR session, the traumatic memory is brought to the surface including associated images, thoughts, feelings and body sensations, while simultaneously focusing on an external distracting stimulus (e.g., lateral eye movements).

Also known as: Psychological intervention

EMDR in person; EMDR remote

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• One of the three conditions below on the PTSD Check List for DSM-5 (PCL-5): A 'moderately or higher' (2-4) score for at least one symptom in each cluster (B, C, D or E), or Three of the four PTSD criteria (one B symptom, one C symptom, two D symptoms and two E symptoms), or A (sub) clinical total score (\>24).
• Being motivated for brief EMDR treatment.
• Parenting a child under treatment of a healthcare provider at the Emma Children's Hospital, Amsterdam UMC.
• Having sufficient knowledge of the Dutch language to complete the questionnaires.

You may not qualify if:

• Major interfering acute medical or psychiatric condition, such as psychosis, substance dependence or high risk for suicide.
• Insufficient fluency of the Dutch language.
• Receiving psychological trauma treatment by another therapist at the same time.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Related Publications (1)

• Vesseur EM, de Roos C, Scholten L, Haverman L. EMpower Parents: Effectiveness of EMDR treatment for parental PTSD related to a child's medical condition in a randomized controlled trial. BMC Psychol. 2025 Jul 17;13(1):799. doi: 10.1186/s40359-025-03043-x.

  PMID: 40676651 DERIVED

MeSH Terms

Interventions

Eye Movement Desensitization Reprocessing; Psychosocial Intervention

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lotte Haverman, Dr.

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esmée Vesseur, MSc.

CONTACT

+316205665674; empowerparents@amsterdamumc.nl

Linde Scholten, Dr.

CONTACT

+316205665674; linde.scholten@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pediatric Psychology Research Section

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 15, 2025
• Study Start: January 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 15, 2025

Record last verified: 2025-01