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IRCT20231106059970N4 IRCT 2026-01-28 Shahid Beheshti University of Medical Sciences unified protocol versus dyadic-developmental psychotherapy for children and adolescent with PTSD comparing the of modified version of unified protocol versus dyadic-developmental psychotherapy in reduction of post-traumatic stress symptoms, dissociation, and self-harm in individuals with developmental/post traumatic stress disorder among survivors of the 12-day war 2026-01-30 anticipated 62 Complete https://irct.ir/trial/88198 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Study will employ block randomization at the individual level. Allocation method: true randomization via 4 and 6 variable block size. Random sequence will be generate by random allocation software. Allocation ratio will be 1:1 in each group. Independent researcher will generated the random sequence. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes, Blinding description: In this study, the therapist delivering the interventions, assessors and and data analyzers will be blinded to group allocation. Participants will be aware that there will be two treatment conditions. blinding will be occur after study will be finished. 3 Condition 1: Post-traumatic stress disorder. Condition 2: unspecified Post-traumatic stress disorder. Intervention 1: Intervention group 1: The Unified Protocol (UP), is emotion-focused cognitive-behavioral therapy. It consists 5 core treatment modules: (1) mindful emotion awareness, (2) cognitive flexibility, (3) identifying and preventing patterns of emotion avoidance, (4) increasing awareness and tolerance of emotion-related physical sensations, and (5) interoceptive and situational emotion-focused exposures. Its 5 core modules are preceded by a module focused on enhancing motivation and an introductory module on the adaptive nature of emotions that provides a framework for understanding emotional experiences. Participants will receive at least 36 individual sessions weekly (1 hour ).The sessions will follow these modules and will be changed based on individuals’ needs and conditions: Psychoeducation and treatment rationale ; Motivation and goal setting; Mindful emotion awareness; Cognitive reappraisal ; Countering emotional avoidance; Awareness of physical sensations; and Imaginal and situational emotional exposures. Intervention 2: Intervention 2: Intervention 2: Dyadic-developmental psychotherapy is a form of psychotherapy that can help form and repair connections and attachment between children, young people and their parent/carers. It tries to create a "playful, accepting, curious, and empathic" environment in which the therapist attunes to the child's "subjective experiences" and reflects this back to the child by means of eye contact, facial expressions, gestures and movements, voice tone, timing. The child and parents working together with the therapist. The child gains relationship experience which helps her to grow and heal emotionally. Family members develop healthy patterns of relating and communicating. It consists five steps: 1: Relationship Building; 2: Problem Assessment; 3: Goal Setting; 4: Counselling Intervention, and 5: Evaluation, Termination. It will be applied through 16 weekly session (60-90 minutes). Yes - There is a plan to make this available What will be shared: Demographic information and the results of measures will be available after deidentifying process When: When the results will be published, researchers could have access to data due to reasonable requests To whom: Data will be available for the mental health researchers Conditions: Data will be available for systematic review Where to obtain: Please contact Dr. Banafsheh Mohajerin Address: Psychology Department, Taleghani Hospital, Arabi St, Yaman St, velenjak. Tehran Tel: 982123031548 Banafshehmohajerin@gmail.com How to obtain: After data will be published, data will be available within one week Comments:
public Banafsheh Mohajerin
Taleghani Hoispital, Arabi St, Yaman St, Velenjak
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2303 1548 banafshehmohajerin@gmail.com Shahid Beheshti University of Medical Sciences scientific Banafsheh Mohajerin
Taleghani Hospital,Arabi St, Yaman St, Velenjak
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2303 1548 banafshehmohajerin@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Meet the diagnostic criteria of Developmental trauma disorder / or Post-traumatic stress disorder Aged between 6 and 65 Be able to speak and read Farsi 6 years 65 years Both met criteria for a psychotic disorder met criteria for Bipolar mood disorder intellectual disability Required specialized treatment for high risk of suicide Missing at least three treatment sessions continuously Primary care giver refuse for participation in this study F43.1 F43.10 Post-traumatic stress disorder (PTSD) Post-traumatic stress disorder, unspecified Treatment - Other Treatment - Other Intervention group 1: The Unified Protocol (UP), is emotion-focused cognitive-behavioral therapy. It consists 5 core treatment modules: (1) mindful emotion awareness, (2) cognitive flexibility, (3) identifying and preventing patterns of emotion avoidance, (4) increasing awareness and tolerance of emotion-related physical sensations, and (5) interoceptive and situational emotion-focused exposures. Its 5 core modules are preceded by a module focused on enhancing motivation and an introductory module on the adaptive nature of emotions that provides a framework for understanding emotional experiences. Participants will receive at least 36 individual sessions weekly (1 hour ).The sessions will follow these modules and will be changed based on individuals’ needs and conditions: Psychoeducation and treatment rationale ; Motivation and goal setting; Mindful emotion awareness; Cognitive reappraisal ; Countering emotional avoidance; Awareness of physical sensations; and Imaginal and situational emotional exposures Intervention 2: Intervention 2: Dyadic-developmental psychotherapy is a form of psychotherapy that can help form and repair connections and attachment between children, young people and their parent/carers. It tries to create a "playful, accepting, curious, and empathic" environment in which the therapist attunes to the child's "subjective experiences" and reflects this back to the child by means of eye contact, facial expressions, gestures and movements, voice tone, timing. The child and parents working together with the therapist. The child gains relationship experience which helps her to grow and heal emotionally. Family members develop healthy patterns of relating and communicating. It consists five steps: 1: Relationship Building; 2: Problem Assessment; 3: Goal Setting; 4: Counselling Intervention, and 5: Evaluation, Termination. It will be applied through 16 weekly session (60-90 minutes). Post-traumatic stress symptoms severity. Timepoint: baseline, after intervention, 6, and 12 months after intervention as a follow-up phas. Method of measurement: by using PTSD Checklist (PCL-5; Blevins et al., 2015). Anger severity. Timepoint: baseline, after intervention, 6, and 12 months after intervention as a follow-up phase. Method of measurement: by using self-report the State–Trait Anger Expression Inventory–2 questionnaire. Dissociative symptoms severity. Timepoint: baseline, after intervention, 6, and 12 months after intervention as a follow-up phase. Method of measurement: by using self-report the dissociative Experiences Scale questionnaire. Shahid Beheshti University of Medical Sciences Approved 2025-10-12 Research Ethics Committees of Shahid Behehshti University of Medical Sciences Arabi St, Yaman St, Velenjak, Tehran Tehran Tehran Iran (Islamic Republic of)