NCT05631691

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

September 20, 2022

Last Update Submit

November 21, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 to 8 week sessions

Study Arms (2)

Experimental Group

EXPERIMENTAL

school students

Behavioral: Support for Students exposed to Trauma Program

Comparison Group

NO INTERVENTION

school students

Interventions

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.

Experimental Group

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • meets the cut off score on scale CATS (child and adolescent trauma screen).
  • students availability for intervention phase
  • age range 10-16 years

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan

Muzaffarabad, Azad Kashmir, 13100, Pakistan

Location

MeSH Terms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: In this study, participants will be screened initially and then by randomization groups will be formed for intervention and comparison group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd Student (Principal investigator)

Study Record Dates

First Submitted

September 20, 2022

First Posted

November 30, 2022

Study Start

December 1, 2022

Primary Completion

May 30, 2023

Study Completion

July 30, 2023

Last Updated

November 30, 2022

Record last verified: 2022-11

Locations