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NCT00600418 Clinical Trial

Identifying Toddlers and Their Parents Who Are Suffering From Posttraumatic Distress Following War and Terror

Stress Disorders, Post-Traumatic Clinical Trial

Official title:
Identifying Posttraumatic Distress Among Toddlers and Their Parents Following Ongoing Exposure to Terrorism or War

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00600418
Other study ID # Rpat2CTIL
Secondary ID
Status Completed
Phase Phase 0
First received August 13, 2007
Last updated September 3, 2013
Start date April 2007
Est. completion date December 2008

Study information
Verified date September 2013
Source Herzog Hospital
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical 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

Description:

A. 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.

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 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.

C. 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.

D. 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

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date December 2008
Est. primary completion date April 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 1 Year to 6 Years
Eligibility Inclusion Criteria:

- Families with children between the age 1-6 years.

- Families living in Sderot, Kyriat Shmona and Haifa

Exclusion Criteria:

- Severe developmental problems

Study Design

Observational Model: Family-Based, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Isreal Center for the Treatment of Psychotrauma Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Herzog Hospital

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Other Maternal flexibility April 2008- December 2008 Yes
Primary PTSD and behavioral and emotional problems April 2007- December 2008 Yes
Secondary Maternal depression and PTSD Aprol 2007- December 2008 Yes
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