跳至主要内容
临床试验/CTRI/2026/01/100219
CTRI/2026/01/100219尚未招募不适用

Development and Validation of a Complex Trauma Scale and Randomised Control Pilot Trial of a Complex Trauma Focused Cognitive Behavior Therapy Intervention for Adolescents

All India Institute of Medical Sciences2 个研究点 分布在 1 个国家目标入组 490 人开始时间: 2026年2月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
490
试验地点
2

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
12.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • 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).
  • 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.

排除标准

  • 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.

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Jaspreet Kaur Mangat

All India Institute of Medical Sciences

研究点 (2)

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