Stress Disorders, Post-TraumaticNCT00600418
Identifying Toddlers and Their Parents Who Are Suffering From Posttraumatic Distress Following War and Terror
An observational study of Stress Disorders, Post-Traumatic, run by Herzog Hospital at 1 site in Israel.
Trial summary
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 3 cities in Israel, Haifa, Kiryat Shmona and Sderot, exposed to terrorism and the effects of war Read more about this study
- Who is it for?
- Ages 1 year to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2007to Dec 2008
- 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 1 year to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Families with children between the age 1-6 years
Who may be able to join
- Families with children between the age 1-6 years.
- Families living in Sderot, Kyriat Shmona and Haifa
Who cannot join
- Severe developmental problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying Posttraumatic Distress Among Toddlers and Their Parents Following Ongoing Exposure to Terrorism or War
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 3 cities in Israel, Haifa, Kiryat Shmona and Sderot, exposed to terrorism and the effects of war
Read the detailed description
- Screening of young children and implementation of treatment The screening will consist of self-report questionnaires and a clinical interview with parents, conducted by trained professional about exposure to traumatic events and resulting post-traumatic specific symptoms among the toddlers and their parents. The screening procedure is bases on the accumulated clinical experience and empirical data gained in the ongoing similar project in Sderot. The level of cooperation by parents and teachers in the ongoing project has been exceptionally high, indicating a tremendous need for knowledge, skills and support. Based upon our previous experience, it is anticipated well-baby clinic nurses will also be extremely interested participation.
- Workshops for parents, teachers, nurses The knowledge and skills of preschool teachers and nurses working in all our projects sights (well baby clinics, day care centers and kindergartens) 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 All toddlers identified with posttraumatic distress will receive dyadic treatment focused on dealing with posttrauma. 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 implementing this cutting-edge treatment received specialized training adjusted to the context of terror and trauma by a child trauma specialist from Mount Sinai Medical Center in New York.
- 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
- Stress Disorders, Post-Traumatic
- Keywords
- PTSD, DYADIC TREATMENT, WAR AND TERROR, Posttraumatic symptoms among toddlers
- Medical subject headings
- Stress Disorders, Post-Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD and behavioral and emotional problems
Measured: April 2007- December 2008
Secondary outcomes (1)
Maternal depression and PTSD
Measured: Aprol 2007- December 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startApr 2007
- Primary completionApr 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herzog Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ruth Pat-Horenzcyk, Herzog Hospital
- Investigators
- Ruth Pat-Horenczyk, Ph.d, Principal investigator, Isreal Center for the Treatment of PsychotraumaRuth Pat-Horenczyk, Ph.D, Principal investigator, The Israel Center for the Treatment of Psychotrauma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600418
- Sponsor's protocol ID
- Rpat2CTIL
- Status last verified
- Sep 2013
- First submitted
- 13 Aug 2007
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Posttraumatic Distress Among Toddlers and Their Parents Following Ongoing Exposure to Terrorism or War
- ClinicalTrials.gov ID
- NCT00600418
- Acronym / sponsor ID
- Rpat2CTIL
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- PTSD, DYADIC TREATMENT, WAR AND TERROR, Posttraumatic symptoms among toddlers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Herzog HospitalUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 25 Jan 2008 (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 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 3 cities in Israel, Haifa, Kiryat Shmona and Sderot, exposed to terrorism and the effects of war
Detailed description
- Screening of young children and implementation of treatment The screening will consist of self-report questionnaires and a clinical interview with parents, conducted by trained professional about exposure to traumatic events and resulting post-traumatic specific symptoms among the toddlers and their parents. The screening procedure is bases on the accumulated clinical experience and empirical data gained in the ongoing similar project in Sderot. The level of cooperation by parents and teachers in the ongoing project has been exceptionally high, indicating a tremendous need for knowledge, skills and support. Based upon our previous experience, it is anticipated well-baby clinic nurses will also be extremely interested participation.
- Workshops for parents, teachers, nurses The knowledge and skills of preschool teachers and nurses working in all our projects sights (well baby clinics, day care centers and kindergartens) 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 All toddlers identified with posttraumatic distress will receive dyadic treatment focused on dealing with posttrauma. 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 implementing this cutting-edge treatment received specialized training adjusted to the context of terror and trauma by a child trauma specialist from Mount Sinai Medical Center in New York.
- 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
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Families with children between the age 1-6 years
Key inclusion criteria (2 listed)
- Families with children between the age 1-6 years.
- Families living in Sderot, Kyriat Shmona and Haifa
Key exclusion criteria (1 listed)
- 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
PTSD and behavioral and emotional problems
Time frame: April 2007- December 2008
1 secondary outcome
Maternal depression and PTSD
Time frame: Aprol 2007- December 2008
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 4 Sep 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
Isreal Center for the Treatment of Psychotrauma
Ruth Pat-Horenczyk, Ph.D principal investigator
The 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 Stress Disorders, Post-Traumatic, 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 4 Sep 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.
What does the primary outcome measure?
PTSD and behavioral and emotional problems (time frame: April 2007- December 2008). It is what the study was designed to measure, not a finding.
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 4 Sep 2013.