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

EMpower Parents: Effectiveness of EMDR Treatment for Parental PTSD Related to Their Child's Medical Condition: a Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: All Acute Pediatric Conditions; All Chronic Pediatric Conditions
• Intervention / Treatment: Other: Eye Movement Desensitization and Reprocessing (EMDR)

Detailed Description

Objective: The primary objective is to assess the effectiveness of a brief (two half-day) in person (EMDRip) and remote (EMDRr) EMDR therapy compared to control group in reducing posttraumatic stress symptoms in parents of children with a chronic or acute medical condition.

The secondary objectives are to assess the effectiveness of brief EMDRip and EMDRr for parents of children with a severe chronic or acute medical condition 1) in reducing psychological comorbidity in parents (psychopathology in general: Depression, Anxiety, and Somatization, and parenting stress), 2) in reducing posttraumatic stress symptoms of their child with a chronic or acute medical condition, and 3) in improving relationship quality between the parent and spouse and between the parent and the child with a severe chronic or acute medical condition. 4) To evaluate the feasibility of EMDRip versus EMDRr.5) To describe the traumatic experiences and future worries (targets) the parents of children with a severe chronic or acute medical condition struggle with.

Study design: This study will be a randomized controlled trial with three study arms: in person EMDR (EMDRip), remote EMDR (EMDRr), waiting list (Control).

Intervention: The EMDR intervention in this study consists of four in person or remote EMDR sessions, each lasting 1.5 hours, spread across two half-days, approximately one week will elapse between the two treatment days. EMDR treatment will be offered by licensed therapists at Amsterdam UMC.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esmée Vesseur, MSc.; Phone Number: +316205665674; Email: empowerparents@amsterdamumc.nl
• Study Contact Backup: Name: Linde Scholten, Dr.; Phone Number: +316205665674; Email: linde.scholten@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waiting list
Experimental: EMDR in person; 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); 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).; Other Names: Psychological intervention
Experimental: EMDR remote; 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); 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).; Other Names: Psychological intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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]
Distress assessed with the Distress Thermometer for Parents, DT-P	From T0 [enrolment] to T1 [2 weeks post end of treatment]
Trauma symptoms child assessed with the Child and Adolescent Trauma Screen, CATS, 3-6 and 7-17 parent version, based on the DSM-5 criteria for PTSD	From T0 [enrolment] to T1 [2 weeks post end of treatment]
Social support assessed with the Social Support subscale of the Family Questionnaire, GVL	From T0 [enrolment] to T1 [2 weeks post end of treatment]
Partner relationship assessed with the Partner Relationship subscale of the Family Questionnaire, GVL	From T0 [enrolment] to T1 [2 weeks post end of treatment]

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility, self-composed questionnaire	To assess the feasibility of EMDR in person versus EMDR remote	2 weeks post treatment follow-up (T1ip, T1r, T.1.c)
Therapy preference, self-composed question	To assess potential therapy preference (in person, remote or hybrid) before start of treatment	Tscreen: part of the first set-of questionnaires parents complete to check for eligibility, pre-intervention.
New traumatic experiences during treatment, self-composed question	To assess if new traumatic experiences occurred after treatment ended	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.
Further treatment need, self-composed question	To assess if participants are in need for psychological treatment after the EMDR treatment of the study	At the last measurement moment for each group: T3ip, T3r: 6 months post end of treatment T2.1c: 3 months post end of treatment
Intake data: traumatic experiences and future worries	During the psychological intake, the following data is collected: 1) Complaints parents, 2) Information about child's illness, 3) Targets (traumatic experiences): title, short description, child's age, SUD (memory), intrusion, frequency, 4) Mental video check/future template, 5) Other information, 6) Psychoeducation PTSD, 7) Explanation EMDR and practice round, 8) Date, time and location of treatment.	At the psychological intake (in between baseline measurement and the start of the intervention)

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Lotte Haverman, Dr., Amsterdam UMC

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Pediatrics; Parents; E-health; EMDR; Posttraumatic stress; Parental PTSD; Trauma therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: NL85854.018.24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No