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IRCT20260616069840N1 IRCT 2026-07-19 Kashan University of Medical Sciences The Effectiveness of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) on Emotional Security, Loneliness, Alexithymia, and Well-Being in Adolescents with Divorced Parents Living in Kashan The Effectiveness of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) on Emotional Security, Loneliness, Alexithymia, and Well-Being in Adolescents with Divorced Parents Living in Kashan 2026-07-11 anticipated 64 Complete https://irct.ir/trial/90964 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A children of divorce. Intervention 1: Intervention group: Adolescents aged 12 to 18 years who are children of divorce.In this group, Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) will be delivered in 12 sessions of 45 to 60 minutes for the adolescents. Additionally, several sessions will be conducted for their guardians or parents. Intervention 2: Control group: Adolescents aged 12 to 18 years who are children of divorce will not receive any treatment and will remain on a waitlist. Yes - There is a plan to make this available What will be shared: Individual participant data from this study will be shared after the trial's completion in a de-identified manner, without any identifiable information. Access to raw data related to the primary outcome variables, including loneliness scores, alexithymia, emotional security, and psychological well-being, will be made available upon request to qualified researchers. Under no circumstances will participants' identifiable information be accessible to individuals outside the research team at any stage. When: The access period begins 6 months and 2 yeras after the results are published To whom: De-identified individual participant data will be made available to qualified researchers. Requests will be accepted only from investigators affiliated with recognized academic institutions, research centers, or scientific organizations with a clear and relevant research purpose. Requests will be reviewed and approved by the study investigators. Conditions: De-identified individual participant data will be used solely for scientific and non-commercial research purposes. Data use is limited to statistical analyses consistent with or complementary to the objectives of the original study. Commercial use, marketing purposes, or any non-scientific applications are strictly prohibited. Data recipients must maintain confidentiality, avoid any attempt to re-identify participants, and are not permitted to share the data with third parties without written permission from the study investigators. Access will be granted only after approval by the principal investigators and in accordance with ethical research principles. Where to obtain: Qualified applicants seeking access to the de-identified data from this study may submit their requests to the principal investigator, Reyhaneh Sadat Sherafat, or to the supervising professor, Dr. Zahra Zanjanizadeh (Zanjani). Requests will be reviewed on a priority basis via email. If necessary, further correspondence will be conducted through the university where the study was conducted. ยท Reyhaneh Sadat Sherafat (Principal Investigator): reyhanesadatsherafat1381@gmail.com How to obtain: Upon receipt of a request for access to de-identified individual participant data, the request will be reviewed by the principal investigator and the research team. The first step involves assessing the scientific merit and eligibility of the applicant. If preliminarily approved, the requester will be required to sign a data use agreement, including confidentiality and non-reidentification commitments. After completion of the required documentation, the requested data will be prepared and shared electronically with the applicant. Additional clarifications, if needed, will be handled via email correspondence. The entire process typically takes between 2 to 4 weeks. Comments:
public Reyhaneh Sadat Sherafat
No. 11, 5th Unit, East Banafsheh Alley, South Salimi Jahromi Street, East Ferdous Boulevard
Tehran Iran (Islamic Republic of) 1481746851 +98 21 4409 3573 Sherafat-r@kaums.ac.ir Kashan University of Medical Sciences scientific Reyhaneh Sadat Sherafat
No. 11, 5th Unit, East Banafsheh Alley, South Salimi Jahromi Street, East Ferdous Boulevard
Tehran Iran (Islamic Republic of) 1481746851 +98 21 4409 3573 reyhanesadatsherafat1381@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Adolescents between 12 and 18 years of age At least 6 months and at most 5 years have passed since the parents' divorce A score below 27 on the Emotional Security Scale (from the Emotional Security Questionnaire) Reporting parental divorce as a traumatic event during the initial interview Absence of severe psychiatric disorders requiring medication or hospitalization (e.g., severe psychotic disorders) Informed consent from both the adolescent and their legal guardian, along with a willingness to participate in the study Basic literacy skills to complete questionnaires or participate in exercises Basic literacy skills to complete questionnaires or participate in exercises Not receiving concurrent psychological intervention 12 years 18 years Both Development of an acute psychiatric condition that prevents continuation of treatment Occurrence of suicidal ideation reported by the participant Occurrence of an incident that prevents or disrupts attendance at sessions Treatment - Other N/A Intervention group: Adolescents aged 12 to 18 years who are children of divorce.In this group, Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) will be delivered in 12 sessions of 45 to 60 minutes for the adolescents. Additionally, several sessions will be conducted for their guardians or parents. Control group: Adolescents aged 12 to 18 years who are children of divorce will not receive any treatment and will remain on a waitlist Emotional Security. Timepoint: Emotional security will be measured at the beginning of the study (before the intervention) and at the end of the study, after receiving 12 sessions of treatment. Method of measurement: Security in the Family System (SIFS). Loneliness. Timepoint: Loneliness will be measured at the beginning of the study (before the intervention) and at the end of the study, after receiving 12 sessions of treatment. Method of measurement: UCLA Loneliness Scale. Alexithymia. Timepoint: Alexithymia will be measured at the beginning of the study (before the intervention) and at the end of the study, after receiving 12 sessions of treatment. Method of measurement: Toronto Alexithymia Scale (TAS-20). Well being. Timepoint: Psychological well-being will be measured at the beginning of the study (before the intervention) and at the end of the study, after receiving 12 sessions of treatment. Method of measurement: Multidimensional Well being in Youth Scale (MWYS). Kashan University of Medical Sciences Approved 2026-05-24 Ethics committee of Kashan University of Medical Sciences Kashan - Qotb-e Ravandi Boulevard - Pezeshk Boulevard (University Campus) kashan Isfehan Iran (Islamic Republic of)