Post-Traumatic Stress DisorderNCT00447538
Posttraumatic Symptoms Among Toddlers and Their Parents Following Exposure to Terrorism
An observational study of Post-Traumatic Stress Disorder, run by Herzog Hospital at 1 site in Israel.
Trial summary
The project utilize experience and knowledge gained from previous early childhood projects in NYC post 9/11 and Sderot. The overall goals are: 1. Identifying young children (under 6 years old) and their parents who are suffering from posttraumatic distress in the aftermath of the continuing conflict on Gaza border… Read more about this study
- Who is it for?
- Ages 24 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorder
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2005to Jan 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
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 24 to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Families with children between 24-48
- Families living in Sderot, Israel
Who cannot join
- Children with severe developmental problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying Distress, Developmental and Behavioral Problems Among Toddlers, and Posttraumatic Distress Among Their Parents Following Continuous Exposure to Terrorism
The project utilize experience and knowledge gained from previous early childhood projects in NYC post 9/11 and Sderot. The overall goals are:
- Identifying young children (under 6 years old) and their parents who are suffering from posttraumatic distress in the aftermath of the continuing conflict on Gaza border, Israel.
- Increasing the capacity of local institutions to treat toddlers and families at risk.
- Providing resilience -building services that strengthen the coping abilities of families and caregivers in response to continual terrorism.
Read the detailed description
This project's aim is to identify psychological distress, build resilience among toddlers and their parents, and treat post traumatic stress disorder. The project components have consisted of a) using resilience-building interventions geared toward helping parents and daycare teachers deal with the stress engendered by the repeated emergency situations b) screening toddlers (24-48 months) for post traumatic distress utilizing new validated instruments c) referring highly symptomatic children and parents to dyadic treatment which focuses on observing the dynamics and interaction between parents and children before treatment intervention with the (more typically) mother/child.
Research into childhood trauma has clearly demonstrated that infants and children impacted by terrorism or with mothers who have suffered traumatic experiences are at very high risk for a multitude of long-term emotional disorders. Mothers suffering the effects of Post Traumatic Stress Disorders (PTSD) have difficulty providing the emotional holding environment and relational foundation necessary for healthy attachment and bonding. An anxious or traumatized mother will have difficulty soothing her child if she herself is in a state of emotional and physical hyper-arousal.
The project is aimed at identifying children who are suffering from posttraumatic distress and increasing capacity to provide treatment for them and for their caretakers. The project will be implemented in Sderot. Professional staff (teachers, nurses and aides) will be trained to conduct a systematic short screening in order to identify families with babies, toddlers and young children suffering from, or at risk for post-traumatic stress disorder.
The elements of the project will consist of:
- Screening of young children and implementation of treatment The screening will consist of a short interviews with parents conducted by trained professional about exposure to traumatic events and resulting post-traumatic specific symptoms among the toddlers and their parents.
- Workshops for parents, teachers, nurses The knowledge and skills of preschool teachers and nurses working in all our projects sights as well as parents will be increased by providing training regarding the impact of war related trauma on preschool children. Workshops will better equip teachers, nurses and parents with knowledge about the emotional impact of trauma on young children and will increase the skills to help preschool children contain emotional distress as well as to help them in coping with the emotional consequences of trauma exposure.
- Treatment Interventions Dyadic treatment involving parents and children is aimed at increasing the attunement of parents to their toddlers and their needs in times of crises. Local practitioners in Sderot will received specialized training in this methodology by a child trauma specialist from Mount Sinai Medical Center in New York. The effectiveness of the dyadic treatment will be evaluated.
- Evaluation of treatment Evaluation of treatment efficacy (dyadic treatment) will be assessed by pre and post interviews that will be conducted by trained professionals with all parents participating in the dyadic treatments in each of the three cities.
- Conditions
- Post-Traumatic Stress Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2007 (estimated)
- Study startNov 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Herzog Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Picower Foundation
- Investigators
- Ruth Pat-Horenczyk, Ph.D, Principal investigator, Israel Center for the Treatment of Psychotrauma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447538
- Sponsor's protocol ID
- Rpat1CTIL
- Status last verified
- Apr 2013
- First submitted
- 13 Mar 2007
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Distress, Developmental and Behavioral Problems Among Toddlers, and Posttraumatic Distress Among Their Parents Following Continuous Exposure to Terrorism
- ClinicalTrials.gov ID
- NCT00447538
- Acronym / sponsor ID
- Rpat1CTIL
- Conditions
- Post-Traumatic Stress Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Herzog HospitalUniversity, hospital or other
- Collaborators
- Picower Foundation
- Study start
- Nov 2005
- Study completion
- Jan 2007
- First posted
- 14 Mar 2007 (estimated)
- 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 project utilize experience and knowledge gained from previous early childhood projects in NYC post 9/11 and Sderot. The overall goals are:
- Identifying young children (under 6 years old) and their parents who are suffering from posttraumatic distress in the aftermath of the continuing conflict on Gaza border, Israel.
- Increasing the capacity of local institutions to treat toddlers and families at risk.
- Providing resilience -building services that strengthen the coping abilities of families and caregivers in response to continual terrorism.
Detailed description
This project's aim is to identify psychological distress, build resilience among toddlers and their parents, and treat post traumatic stress disorder. The project components have consisted of a) using resilience-building interventions geared toward helping parents and daycare teachers deal with the stress engendered by the repeated emergency situations b) screening toddlers (24-48 months) for post traumatic distress utilizing new validated instruments c) referring highly symptomatic children and parents to dyadic treatment which focuses on observing the dynamics and interaction between parents and children before treatment intervention with the (more typically) mother/child.
Research into childhood trauma has clearly demonstrated that infants and children impacted by terrorism or with mothers who have suffered traumatic experiences are at very high risk for a multitude of long-term emotional disorders. Mothers suffering the effects of Post Traumatic Stress Disorders (PTSD) have difficulty providing the emotional holding environment and relational foundation necessary for healthy attachment and bonding. An anxious or traumatized mother will have difficulty soothing her child if she herself is in a state of emotional and physical hyper-arousal.
The project is aimed at identifying children who are suffering from posttraumatic distress and increasing capacity to provide treatment for them and for their caretakers. The project will be implemented in Sderot. Professional staff (teachers, nurses and aides) will be trained to conduct a systematic short screening in order to identify families with babies, toddlers and young children suffering from, or at risk for post-traumatic stress disorder.
The elements of the project will consist of:
- Screening of young children and implementation of treatment The screening will consist of a short interviews with parents conducted by trained professional about exposure to traumatic events and resulting post-traumatic specific symptoms among the toddlers and their parents.
- Workshops for parents, teachers, nurses The knowledge and skills of preschool teachers and nurses working in all our projects sights as well as parents will be increased by providing training regarding the impact of war related trauma on preschool children. Workshops will better equip teachers, nurses and parents with knowledge about the emotional impact of trauma on young children and will increase the skills to help preschool children contain emotional distress as well as to help them in coping with the emotional consequences of trauma exposure.
- Treatment Interventions Dyadic treatment involving parents and children is aimed at increasing the attunement of parents to their toddlers and their needs in times of crises. Local practitioners in Sderot will received specialized training in this methodology by a child trauma specialist from Mount Sinai Medical Center in New York. The effectiveness of the dyadic treatment will be evaluated.
- Evaluation of treatment Evaluation of treatment efficacy (dyadic treatment) will be assessed by pre and post interviews that will be conducted by trained professionals with all parents participating in the dyadic treatments in each of the three cities.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 24 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Families with children between 24-48
- Families living in Sderot, Israel
Key exclusion criteria (1 listed)
- Children with severe developmental problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
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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. This study is not recruiting at the moment.
Ruth Pat-Horenczyk, Ph.D principal investigator
Israel Center for the Treatment of Psychotrauma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Traumatic Stress Disorder, run by Herzog Hospital at 1 site in Israel.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 30 Apr 2013.