Interventional StudyNCT05631691
Impact of School Based Intervention on Psychosocial Factors Associated With Trauma Among Adolescents
A study testing Support for Students exposed to Trauma Program in people with Interventional Study, run by Fatima Jinnah Women University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Interventional Study
- What is being tested?
- Support for Students exposed to Trauma Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2022to 30 Jul 2023
- Phase
- Interventional
- 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 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- meets the cut off score on scale CATS (child and adolescent trauma screen).
- students availability for intervention phase
- age range 10-16 years
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan
Muzaffarabad, Azad Kashmir, 13100
Nayyab Khurshid, 03005599255, nayyab.khurshid09@gmail.com
Sajida Naz, 03235493535, dr.sajida@fjwu.edu.pk
About this study
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.
Read the 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.
- Conditions
- Interventional Study
- Being tested
- Support for Students exposed to Trauma Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support for Students exposed to Trauma ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | school students Receives: Behavioral: Support for Students exposed to Trauma Program |
| Comparison Group | No intervention | school students |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in symptoms of PTSD, psychological distress, behavioral problems and increases resilience and social support of students who have some traumatic exposure
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.
Measured: 6 to 8 week sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start1 Dec 2022 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interventional StudyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, participants will be screened initially and then by randomization groups will be formed for intervention and comparison group.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Women University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayyab Khurshid, Fatima Jinnah Women University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631691
- Sponsor's protocol ID
- FJWU
- Status last verified
- Nov 2022
- First submitted
- 20 Sep 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of School Based Intervention on Psychosocial Factors Associated With Trauma Among Adolescents
- ClinicalTrials.gov ID
- NCT05631691
- Acronym / sponsor ID
- FJWU
- Conditions
- Interventional Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fatima Jinnah Women UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 30 Nov 2022 (actual)
- 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 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this study, participants will be screened initially and then by randomization groups will be formed for intervention and comparison group.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Support for Students exposed to Trauma Programschool students |
| Comparison Group | No intervention | –school students |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- meets the cut off score on scale CATS (child and adolescent trauma screen).
- students availability for intervention phase
- age range 10-16 years
Key exclusion criteria (3 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Support for Students exposed to Trauma ProgramSupport 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. | Behavioural | Experimental Group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Support for Students exposed to Trauma Program in people with Interventional Study, run by Fatima Jinnah Women University at 1 site in Pakistan.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Nov 2022. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nayyab Khurshid (03005599255, nayyab.khurshid09@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 30 Nov 2022.