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CTRI Number  CTRI/2026/01/100219 [Registered on: 02/01/2026] Trial Registered Prospectively
Last Modified On: 24/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Psychological Tool development and Psychotherapy Intervention]  
Study Design  Other 
Public Title of Study   Complex Trauma Tool and Intervention development for school going adolescents 
Scientific Title of Study   Development and Validation of a Complex Trauma Scale and Randomised Control Pilot Trial of a Complex Trauma Focused Cognitive Behavior Therapy Intervention for Adolescents 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jaspreet Kaur Mangat 
Designation  PhD Scholar 
Affiliation  All India Institute of Medical Sciences  
Address  Department of Psychiatry, Fourth Floor, Room number 4082A, Teaching Block, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  9910277896  
Fax    
Email  jaspreet.psy@aiims.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sujata Satapathy  
Designation  Professor, Clinical Psychology 
Affiliation  All India Institute of Medical Sciences  
Address  Department of Psychiatry, Fourth Floor, Room number 4082A, Teaching Block, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  9999267141  
Fax    
Email  dr.sujatasatapathy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jaspreet Kaur Mangat 
Designation  PhD Scholar 
Affiliation  All India Institute of Medical Sciences  
Address  Department of Psychiatry, Fourth Floor, Room number 4082A, Teaching Block, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  9910277896  
Fax    
Email  jaspreet.psy@aiims.edu  
 
Source of Monetary or Material Support  
All India Institute of Medical Science New Delhi, Sri Aurobindo Marg, Ansari Nagar East, New Delhi 110029 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences  
Address  Sri Aurobindo Marg, Ansari Nagar East, New Delhi 110029 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajesh Sagar  All India Institute of Medical Sciences, New Delhi  Secondary and Senior Secondary schools of New Delhi NCR
East
DELHI 
9810575310

rsagar29@gmail.com 
Dr Sujata Satapathy  All India Institute of Medical Sciences, New Delhi  New Rajkumari OPD (New RAK), Psychiatry, First Floor, AIIMS, New Delhi
Central
DELHI 
9999267141

sujatasatapathy2022@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F431||Post-traumatic stress disorder (PTSD),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Complex Trauma Focused cognitive behavior therapy for Adolescents with CPTSD  Adolescents who will form the interventional or experimental group will receive a complex psychological trauma focused cognitive behavior therapy module with 6-8 sessions with duration for each session being 60 minutes. Delivery setting will be schools in Delhi. Delivery will be done by licensed a clinical psychologist.  
Comparator Agent  Control who will be provided with the psychoeducation module for complex trauma focused cognitive behavioral therapy  Comparator group will receive the psychoeducation module focusing on what is Complex trauma, its impacts on adolescents, and ways to effectively deal with some of the impacts  
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Inclusion criteria for experimental group (Phase I Tool Development)
Male and female adolescents aged between 12-18 years
History of experience of complex trauma as operationalized for this study (minimum 1 trauma and at least low severity in both as per CTQ cutoffs severity of abuse experiences: Scores 6 and above on sexual abuse, 8 and above on physical abuse and physical neglect, 9 and above on emotional abuse, 10 and above on emotional neglect). Additionally will use CATS-2 for assessing other traumatic events.
Adolescents meeting criteria for C-PTSD as per Clinical descriptions and diagnostic requirements for ICD-11 mental, behavioral and neurodevelopmental disorders (CDDR) (WHO, 2024).
With/without comorbid conditions
Those who provide consent and assent

Inclusion criteria for control group (Phase I Tool Development)
Male and female adolescents aged between 12-18 years
No history of traumatic life experiences as per CTQ cutoffs and severity of abuse experiences.
With/without comorbid conditions
Those who provide consent and assent

Inclusion criteria for experimental and control group (Phase II Intervention Development)
Male and female adolescents aged between 12-18 years
History of experience of complex trauma as operationalized for this study (minimum 1 trauma and at least low severity in both as per CTQ cutoffs severity of abuse experiences: Scores 6 and above on sexual abuse, 8 and above on physical abuse and physical neglect, 9 and above on emotional abuse, 10 and above on emotional neglect). Additionally will use CATS-2 for assessing other traumatic events.
Adolescents meeting criteria for C-PTSD as per Clinical descriptions and diagnostic requirements for ICD-11 mental, behavioral and neurodevelopmental disorders (CDDR) (WHO, 2024)
With/without comorbid conditions
Those who provide consent and assent
Psychotherapy naïve

 
 
ExclusionCriteria 
Details  Exclusion criteria for experimental and control group (Phase I Tool Development)
Diagnosed case of physical, neurological disability which will cause restriction in study participation
Diagnosed case of severe mental illness including BPAD, OCD, Psychosis, substance use disorders(except nicotine), neurodevelopmental disorders (as per school/medical records for ID, ASD, ADHD)
Unable to understand and report in Hindi or English.
Refused to give consent or assent
Caution: Adolescents with active suicidal ideas/attempts will be counselled for treatment help-seeking and parents will be informed through the school authority while maintaining the confidence. Referral to AIIMS will be facilitated if they are willing to take treatment.

Exclusion criteria for experimental and control group (Phase II Intervention Development)
Diagnosed case of physical, neurological disability which will cause restriction in study participation
Diagnosed case of severe mental illness including BPAD, OCD, Psychosis, substance use disorders, neurodevelopmental disorders (ID, ASD, ADHD)
Non- Complex Trauma history and/or less than 2 traumas with no level of abuse on CTQ.
Either of the parents/primary caregivers unavailable
Unable to understand and report in Hindi or English
Refused to give consent or assent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1) The developed complex trauma scale will have acceptable content validity index, acceptable psychometric properties and sensitivity and specificity.
2) Reduction in self reported scores of C-PTSD, attachment, dissociation, resilience, difficulties in emotional regulation, depression, anxiety and stress, risk taking and self-harm, posttraumatic growth and behavioral problems.  
Three time points, pre assessment, immediate post assessment and 3 months follow up  
 
Secondary Outcome  
Outcome  TimePoints 
Post Traumatic Growth Inventory (Child version)  Three time points, pre assessment, immediate post assessment and 3 months follow up  
 
Target Sample Size   Total Sample Size="490"
Sample Size from India="490" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Complex trauma (CT) results from exposure to significant stressors, including emotional, physical, and sexual abuse, neglect, and witnessing of familial violence, primarily commencing in childhood or adolescence. Such experiences frequently reoccur due to repeated exposure and are typically imposed within caregiving contexts or by adults expected to offer security, protection, and stability (Courtois & Ford, 2009).

Recent studies indicate that the amount and variety of interpersonal traumas experienced by adolescents significantly predict the severity and type of their subsequent psychological symptoms and disorders. Traumatic life events, including rape, physical assault, sex trafficking, torture, and combat, are often reported to occur in conjunction with previous childhood abuse and/or neglect. Exposure to various traumatic life events (TLEs) leads to complex and diverse effects on adolescents. Childhood maltreatment generally has unique effects on children in contrast to adolescents or adults, leading to a diverse range of traumas that typically results in a wider array of symptoms. Furthermore, trauma serves as a risk factor for subsequent revictimization, resulting in progressively intricate effects. Additional variables complicate this clinical scenario. Multiple instances of trauma exposure are frequently associated with reduced emotional regulation capabilities, pre-existing or concurrent anxiety, depressive or personality disorders, impulsivity, dissociation, substance dependency, and a background of insecure parent-child attachment. These events indicate complex posttraumatic outcomes and may also exacerbate or moderate the effects of trauma exposure (Lawson & Quinn, 2013).

Adolescents with complex trauma histories undergo evaluations of childhood adversity that include multiple dimensions, each of which is differentially linked to the risks faced by these adolescents. Evaluating childhood adversity in adolescents can aid in the targeted implementation of interventions for specific risks, such as substance use, based on the type of childhood adversity experienced (Beal et al., 2019).

Defining complex trauma, including the traumatic events and their subsequent effects, is essential for furthering research and preventing the unjust stigmatization of traumatized children and adolescents. A thorough understanding of the effects of complex trauma on children would allow clinicians to enhance protective factors and develop treatment strategies that support children’s recovery (Kliethermes, Schacht & Drewry, 2014.)

Recent instruments, such as CATS-2 and the ITQ-CA for ICD-11 CPTSD, have the ability of assessing PTSD/CPTSD symptoms in youth. However, the majority of psychometric evidence is derived from Western contexts or limited-language samples, primarily focusing on studies that validate translations in individual non-Indian languages, such as Chinese and Farsi. Evidence is scarce regarding a developmentally sensitive instrument in Hindi, culturally adapted, that includes Indian normative or clinical data for individuals aged 12 to 18 years. This measurement gap is significant as culturally incongruent items diminish both validity and clinical utility. Cultural beliefs regarding family privacy, stigma, help-seeking behaviors, and disciplinary practices influence symptom expression and the propensity to endorse specific items, such as shame, family loyalty, and somatic presentations.

Complex Trauma in adolescence is multi-dimensional and requires instruments that assess impact (functioning, DSO/ self-organization, attachment, behavioral/academic outcomes) rather than symptom counts alone. Adolescents with polytraumatization show broad functional impairments (psychosocial development, school/occupational participation) that are not captured by single-incident PTSD screeners. A dedicated impact scale that measures domains such as cognitive competence, emotion regulation, interpersonal functioning, and behavioral dysregulation among others will enable better case formulation and treatment planning.  

An impact scale designed for administration in school or primary care settings (for 12–18 years), with clear scoring and cutoffs for referral, will facilitate early identification of adolescent mental health. Recent reviews of trauma assessment tools and psychometric resources in India reveal a shortage in trauma instruments specifically designed for adolescents, as well as a scarcity of Hindi translations for specialized trauma and complex PTSD measures. This highlights the necessity for developing a complex trauma impact assessment scale grounded in the Indian context.

TF-CBT is effective in alleviating core PTSD symptoms and has been adapted for children and adolescents with complex presentations. However, its protocols were originally designed for single-incident trauma models. Complex trauma is characterized by disturbances in self-organization, attachment, and cognition, necessitating phased, multimodal approaches that include stabilization, skill-building, trauma processing, and integration. Empirical studies and reviews suggest that TF-CBT is effective, yet they also underscore its limitations and the necessity for customized approaches for complex cases (Cohen et al., 2022).

Models such as ARC, phased TF-CBT adaptations, and interventions targeting disturbances in self-organization show promise; however, cultural, familial, and implementation contexts in India (e.g., multigenerational households, stigma, school access) require modifications for acceptability and scalability. Thus, phased, developmentally-sensitive CBT packages (integrating skills for affect regulation, attachment repair, and identity) need cultural adaptation and testing in India.

Finally, the development and validation of an Indian, Hindi/English impact assessment scale for complex trauma in adolescents (12–18 years) and the testing of a culturally adapted, complex-trauma-focused CBT intervention will address significant gaps. This will offer valid measurements for case identification and outcome monitoring, enable clinicians to address the extensive functional sequelae of complex trauma, and produce evidence regarding culturally appropriate treatment models suitable for implementation in schools and hospitals. 
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