- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05631691
Impact of School Based Intervention on Psychosocial Factors Associated With Trauma Among Adolescents
November 21, 2022 updated by: Nayyab Khurshid, Fatima Jinnah Women University
The present study is designed to identifying the post-traumatic stress symptoms in children experiencing some traumatic event and to adapt and apply school based intervention (Support for students exposed to trauma SSET) to students who shows the symptoms of post-traumatic stress disorder.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Childhood trauma is a major mental health problem in recent era.
Children who experienced sudden trauma have difficulty in learning, poor concentration in schools, and faced emotional and behavioral difficulties (Holt, Finkelhor, Kantor, 2007).
Children who have been exposed to traumatic event are at a higher risk of developing psychopathology followed by trauma (Alisic et al.,2014).
The present study is designed to identifying the post-traumatic stress symptoms in children experiencing some traumatic event and to adapt and apply school based intervention (Support for students exposed to trauma SSET) to students who shows the symptoms of post-traumatic stress disorder.
This school based intervention (SSET) will provides a basis for how students can address overwhelming emotions, can deal with their daily life stressors and proactively learn to address unhelpful or maladaptive cognitions in positive way.
This study will help to aware parents and teachers about mental health needs of children and adolescents.
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nayyab Khurshid
- Phone Number: 03005599255
- Email: nayyab.khurshid09@gmail.com
Study Contact Backup
- Name: Dr. Sajida Naz
- Phone Number: 03235493535
- Email: dr.sajida@fjwu.edu.pk
Study Locations
-
-
Azad Kashmir
-
Muzaffarabad, Azad Kashmir, Pakistan, 13100
- Pakistan
-
Contact:
- Nayyab Khurshid
- Phone Number: 03005599255
- Email: nayyab.khurshid09@gmail.com
-
Contact:
- Sajida Naz
- Phone Number: 03235493535
- Email: dr.sajida@fjwu.edu.pk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria of the study is:
- meets the cut off score on scale CATS (child and adolescent trauma screen).
- students availability for intervention phase
- age range 10-16 years
Exclusion Criteria:
- students above 16 years and below 10 years will not be included in the study.
- receiving any psychological/Mental health services or taking antidepressants
- Students whose primary problem is child abuse .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
school students
|
Support for students exposed to trauma program (SSET) is a school-based intervention program for students who have been exposed to traumatic events and exhibit signs of post-traumatic stress disorder (PTSD).
(Jaycox, Langley, & Dean, 2009; Jaycox, Langley, Stein et al., 2009).
SSET is specifically designed for school teachers, school counsellors, and other non-clinical staff.
SSET program is a series of 10 structured lessons designed to reduce post-traumatic and depressive symptoms and improve functioning in school children exposed to traumatic events.
it includes psycho-education, relaxation, cognitive restructuring, social problems solving and behavioral exposure.
|
|
No Intervention: Comparison Group
school students
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction in symptoms of PTSD, psychological distress, behavioral problems and increases resilience and social support of students who have some traumatic exposure
Time Frame: 6 to 8 week sessions
|
The outcome of this study is to reduces the symptoms of PTSD and psychological distress in students who have some exposure to traumatic event and to increases participants social support and resilience.
Participants will be assessed before and after intervention by standardized questionnaires: Child and Adolescent Trauma Screen questionnaire, Revised Children Anxiety and Depression scale, Strength and Difficulty questionnaire, Perceived Social Support Scale, and Youth Resilience Scale.
|
6 to 8 week sessions
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2022
Primary Completion (Anticipated)
May 30, 2023
Study Completion (Anticipated)
July 30, 2023
Study Registration Dates
First Submitted
September 20, 2022
First Submitted That Met QC Criteria
November 21, 2022
First Posted (Actual)
November 30, 2022
Study Record Updates
Last Update Posted (Actual)
November 30, 2022
Last Update Submitted That Met QC Criteria
November 21, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- FJWU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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