All Acute Pediatric ConditionsEMpowerNCT06776744
EMpower Parents: Effectiveness of EMDR Treatment for Parental PTSD Related to Their Child's Medical Condition.
A study testing Eye Movement Desensitization and Reprocessing (EMDR) in people with All Acute Pediatric Conditions and All Chronic Pediatric Conditions, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- All Acute Pediatric Conditions, All Chronic Pediatric Conditions
- What is being tested?
- Eye Movement Desensitization and Reprocessing (EMDR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Being tested
- Eye Movement Desensitization and Reprocessing (EMDR)
- Keywords
- EMDR, Pediatrics, Posttraumatic stress, Parental PTSD, Parents, Trauma therapy, E-health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Movement Desensitization and Reprocessing (EMDR)Other
Also called Psychological intervention
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Eye Movement Desensitization and Reprocessing (EMDR) |
| Waiting list | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic stress (symptoms) assessed with the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Measured: 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
Measured: 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
Measured: 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
Measured: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Parenting stress assessed with the Parenting Burden Questionnaire, OBVL
Measured: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Parent-child relationship assessed with the Parenting Burden Questionnaire, OBVL
Measured: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Distress assessed with the Distress Thermometer for Parents, DT-P
Measured: 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
Measured: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Social support assessed with the Social Support subscale of the Family Questionnaire, GVL
Measured: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Partner relationship assessed with the Partner Relationship subscale of the Family Questionnaire, GVL
Measured: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for All Acute Pediatric ConditionsStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lotte Haverman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Lotte Haverman, Dr., Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776744
- Sponsor's protocol ID
- NL85854.018.24
- Acronym
- EMpower
- Status last verified
- Jan 2025
- First submitted
- 23 Dec 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40676651
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMpower Parents: Effectiveness of EMDR Treatment for Parental PTSD Related to Their Child's Medical Condition: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06776744
- Acronym / sponsor ID
- EMpower / NL85854.018.24
- Keywords
- EMDR, Pediatrics, Posttraumatic stress, Parental PTSD, Parents, Trauma therapy, E-health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EMDR in person | Experimental | Other: Eye Movement Desensitization and Reprocessing (EMDR)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. |
| EMDR remote | Experimental | Other: Eye Movement Desensitization and Reprocessing (EMDR)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. |
| Waiting list | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye Movement Desensitization and Reprocessing (EMDR)Also: Psychological interventionEye 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 | EMDR in person, EMDR remote |
Primary outcome
Posttraumatic stress (symptoms) assessed with the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
9 secondary outcomes
Psychological comorbidity - Anxiety assessed with the Dutch-Flemish PROMIS Bank v1.0 - Anxiety
Time frame: 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
Time frame: 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
Time frame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Parenting stress assessed with the Parenting Burden Questionnaire, OBVL
Time frame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Parent-child relationship assessed with the Parenting Burden Questionnaire, OBVL
Time frame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Distress assessed with the Distress Thermometer for Parents, DT-P
Time frame: 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
Time frame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Social support assessed with the Social Support subscale of the Family Questionnaire, GVL
Time frame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Partner relationship assessed with the Partner Relationship subscale of the Family Questionnaire, GVL
Time frame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Derived from this study: PubMed 40676651Vesseur 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lotte Haverman, Dr. principal investigator
Amsterdam UMC
Questions about this trial
What is this clinical trial studying?
A study testing Eye Movement Desensitization and Reprocessing (EMDR) in people with All Acute Pediatric Conditions and All Chronic Pediatric Conditions, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esmée Vesseur, MSc. (+316205665674, empowerparents@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posttraumatic stress (symptoms) assessed with the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) (time frame: From T0 [enrolment] to T1 [2 weeks post end of treatment]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06776744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.