Clinical trial NCT06776744: EMpower Parents: Effectiveness of EMDR Treatment for Parental PTSD Related to Their Child's Medical Condition.
Official title: EMpower Parents: Effectiveness of EMDR Treatment for Parental PTSD Related to Their Child's Medical Condition: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: All Acute Pediatric Conditions
All Chronic Pediatric Conditions
Keywords: EMDR
Pediatrics
Posttraumatic stress
Parental PTSD
Parents
Trauma therapy
E-health
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Posttraumatic stress (symptoms) assessed with the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Secondary outcomes:
measure: Psychological comorbidity - Anxiety assessed with the Dutch-Flemish PROMIS Bank v1.0 - Anxiety
timeFrame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
measure: Psychological comorbidity - Depression assessed with the Dutch-Flemish PROMIS Item Bank v1.0 - Depression
timeFrame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
measure: Psychological comorbidity - Somatization assessed with the Brief Symptom Inventory-18, BSI-18, subscale Somatic Symptoms
timeFrame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
measure: Parenting stress assessed with the Parenting Burden Questionnaire, OBVL
timeFrame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
measure: Parent-child relationship assessed with the Parenting Burden Questionnaire, OBVL
timeFrame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
measure: Distress assessed with the Distress Thermometer for Parents, DT-P
timeFrame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
measure: 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
timeFrame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
measure: Social support assessed with the Social Support subscale of the Family Questionnaire, GVL
timeFrame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
measure: Partner relationship assessed with the Partner Relationship subscale of the Family Questionnaire, GVL
timeFrame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Other outcomes:
measure: Feasibility, self-composed questionnaire
timeFrame: 2 weeks post treatment follow-up (T1ip, T1r, T.1.c)
measure: Therapy preference, self-composed question
timeFrame: Tscreen: part of the first set-of questionnaires parents complete to check for eligibility, pre-intervention.
measure: New traumatic experiences during treatment, self-composed question
timeFrame: 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.
measure: Further treatment need, self-composed question
timeFrame: At the last measurement moment for each group: T3ip, T3r: 6 months post end of treatment T2.1c: 3 months post end of treatment
measure: Intake data: traumatic experiences and future worries
timeFrame: At the psychological intake (in between baseline measurement and the start of the intervention)
Locations:
Study officials:
affiliation: Amsterdam UMC
name: Lotte Haverman, Dr.
role: PRINCIPAL_INVESTIGATOR
References: