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| Tracking Information | |||||||||
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| First Received Date † | August 13, 2007 | ||||||||
| Last Updated Date | January 15, 2008 | ||||||||
| Start Date † | April 2007 | ||||||||
| Current Primary Outcome Measures † | |||||||||
| Original Primary Outcome Measures † | |||||||||
| Change History | Complete list of historical versions of study NCT00600418 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | Identifying Toddlers and Their Parents Who Are Suffering From Posttraumatic Distress Following War and Terror | ||||||||
| Official Title † | Identifying Posttraumatic Distress Among Toddlers and Their Parents Following Ongoing Exposure to Terrorism or War | ||||||||
| Brief 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, exposued to terrorism and the effects of war |
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| Detailed Description | A. Screening of young children and implementation of treatment The screening will consist of self-report quesionniares 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. B. 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 kindergardens) 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. C. Treatment Interventions All toddlers identifyed 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. D. Evaluation of treatment Evaluation of treatment efficacy (dayadic 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 |
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| Study Phase | Phase 0 | ||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Retrospective | ||||||||
| Condition † | Stress Disorders, Post-Traumatic | ||||||||
| Intervention † | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Estimated Enrollment † | 500 | ||||||||
| Estimated Completion Date | April 2008 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 1 Year to 6 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | Israel | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00600418 | ||||||||
| Responsible Party | |||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Herzog Hospital | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Herzog Hospital | ||||||||
| Verification Date | August 2007 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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