NCT07768540

Brief Summary

This study will evaluate whether a school-based counseling program, Cognitive Behavioral Intervention for Trauma in Schools (CBITS), helps reduce trauma-related symptoms and improve psychological functioning in adolescents in Pakistan who have experienced traumatic events. Students will first be screened to identify those with trauma exposure and related symptoms. Eligible students will receive the CBITS program, delivered at their school by the researcher. Researcher will measure changes in trauma-related symptoms and other psychological outcomes before and after the intervention to determine whether the program is effective for this population.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress68%
Dec 2025Feb 2027

Study Start

First participant enrolled

December 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

August 17, 2026

Status Verified

August 1, 2026

Enrollment Period

1.2 years

First QC Date

August 11, 2026

Last Update Submit

August 14, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Child and Adolescent Trauma Screen 2 (Cats-2) Self-Report (7-17 Years)

    The Child and Adolescent Trauma Screen 2 (CATS-2) Self-Report (7-17 Years) is used to assess trauma-related symptoms. Possible scores range from 0 to 60, with higher scores indicating more posttraumatic stress symptoms

    Baseline and 10 weeks

  • Depression Anxiety Stress Scales - Youth Version (DASS-Y)

    The Depression Anxiety Stress Scales - Youth Version (DASS-Y) was used to assess psychological distress, with possible scores ranging from 0 to 63, where higher scores indicate greater psychological distress

    Baseline and 10 weeks

Secondary Outcomes (3)

  • Children's Post-Traumatic Cognitions Inventory (CPTCI-S)

    Baseline and 10 weeks

  • The Difficulties in Emotion Regulation Scale Short Form (DERS-SF)

    Baseline and 10 weeks

  • Multidimensional Scale of Perceived Social Support (MSPSS)

    Baseline and 10 weeks

Study Arms (2)

Intervention Group (receiving CBITS)

EXPERIMENTAL

Students in this group will receive the Cognitive Behavioral Intervention for Trauma in Schools, during the school hours

Behavioral: cognitive behavioral intervention for trauma in schools

Control Group (waitlist control group)

NO INTERVENTION

Students in this group will follow their regular school routine without any changes.

Interventions

Participants in the intervention group will receive Cognitive Behavioral Intervention for Trauma in Schools (CBITS), a manualized, school-based group therapy program for adolescents with trauma-related symptoms. The program includes approximately 10 group sessions (45-60 minutes) covering psychoeducation, relaxation training, cognitive restructuring, trauma narrative development, and social problem-solving. Individual sessions may be included to support the trauma narrative component.

Intervention Group (receiving CBITS)

Eligibility Criteria

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

You may qualify if:

  • Students who are 10-16 years of age, have experienced at least one trauma.

You may not qualify if:

  • Students who have sexual abuse as only traumatic event

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Of Modern Languages (NUML), Islamabad

Islamabad, Pakistan

RECRUITING

MeSH Terms

Interventions

Schools

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Researcher & Principal Investigator

Study Record Dates

First Submitted

August 11, 2026

First Posted

August 17, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

August 17, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations