Child Sexual AbuseNCT07732335
Intensive Inpatient Trauma-Focused Cognitive Behavioral Therapy (II-TF-CBT) for Adolescents With PTSD Following Sexual Abuse
An observational study of Child Sexual Abuse and Post-Traumatic Stress Disorder, PTSD, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study looks at a treatment program for children and teens who have post-traumatic stress disorder (PTSD) after sexual abuse. The program is called II-TF-CBT. It is a special version of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), a type of cognitive behavioral therapy that helps people process trauma. Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Sexual Abuse, Post-Traumatic Stress Disorder, PTSD
- What is being tested?
- II-TF-CBT
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2025to 27 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 'The study population consists of children and adolescents aged 11-17 years diagnosed with post-traumatic stress disorder (PTSD) according to DSM-5 criteria following sexual abuse, presenting to the inpatient and outpatient services of our clinic. Patients were enrolled over an 18-month period following ethics committee approval. Those clinically prioritized for hospitalization received inpatient treatment with the II-TF-CBT protocol; those with a similar clinical presentation who were awaiting inpatient admission continued outpatient follow-up during this period and formed the control group.'
Who may be able to join
- Age 11-17 years.
- Diagnosis of post-traumatic stress disorder (PTSD) according to DSM-5 criteria following sexual abuse.
- Admitted for inpatient treatment in the hospital's child and adolescent psychiatry inpatient unit within the 18-month enrollment period (II-TF-CBT group), or placed on the inpatient admission waiting list and followed in the outpatient clinic during the same period (outpatient control group).
- Patients meeting all eligibility criteria during the enrollment period were included.
- Assignment to the inpatient or outpatient control group was determined by clinical prioritization and admission order rather than by investigators.
Who cannot join
- Age younger than 11 years or older than 17 years.
- Refusal to participate in the study.
- Schizophrenia or another active psychotic disorder.
- Current manic episode.
- Intellectual disability.
- Pervasive developmental disorder.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yenimahalle Training and Research Hospital
Ankara, Ankara, 06370
About this study
Official title: The Efficacy of Intensive Inpatient Trauma-Focused Cognitive Behavioral Therapy (II-TF-CBT)
This study looks at a treatment program for children and teens who have post-traumatic stress disorder (PTSD) after sexual abuse. The program is called II-TF-CBT. It is a special version of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), a type of cognitive behavioral therapy that helps people process trauma. II-TF-CBT is used with patients who stay in the hospital during treatment.
Researchers want to know if II-TF-CBT helps young patients recover as well as, or better than, standard outpatient treatment. Outpatient treatment means patients visit the clinic but do not stay overnight.
Read more
The study compares two groups. One group of 42 patients received II-TF-CBT during a hospital stay. The other group of 33 patients received standard outpatient treatment. Patients needing inpatient care were placed on an admission waiting list and admitted as their turn came; the remaining patients continued outpatient follow-up. Group placement therefore happened naturally, without researcher intervention.
Doctors measured each patient's PTSD symptoms and related problems before treatment, after treatment, and at a follow-up visit. This will help show whether inpatient TF-CBT-based care can help children and teens recover from trauma.
- Being tested
- II-TF-CBT
- Medical subject headings
- Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
II-TF-CBTBehavioural
An inpatient adaptation of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for children and adolescents with post-traumatic stress disorder following sexual abuse. The protocol follows the standard TF-CBT components (psychoeducation, relaxation, affect regulation, cognitive coping, trauma narrative, in vivo mastery, conjoint sessions, and safety enhancement), delivered during inpatient hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| II-TF-CBT (Inpatient) | Patients hospitalized for treatment who received the II-TF-CBT protocol - an inpatient adaptation of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) that includes an added Intake phase prior to the standard TF-CBT components. Patients were admitted from a waiting list of children and adolescents requiring inpatient care for post-traumatic stress disorder (PTSD) following sexual abuse. Group assignment occurred naturally based on bed availability and admission order, not by researcher allocation. N=42. Receives: Behavioral: II-TF-CBT | |
| Outpatient Follow-up (Control) | Patients who continued standard outpatient treatment for PTSD following sexual abuse, without hospitalization. These patients remained on outpatient follow-up because they did not require or were not admitted for inpatient care. Group assignment occurred naturally based on clinical need, not by researcher allocation. N=33. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Global Impression-Severity (CGI-S) Score
The CGI-S is a clinician-rated scale assessing the overall severity of the patient's psychiatric symptoms on a 7-point scale, ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Change in CGI-S score over the course of treatment reflects overall clinical improvement in trauma-related symptom severity. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate greater illness severity (worse outcome).
Measured: Baseline, Week 2, and Week 4)
Secondary outcomes (3)
Change in Children's Depression Inventory (CDI) Total Score
The CDI is a self-report scale assessing the severity of depressive symptoms in children and adolescents. Change in CDI score reflects change in depressive symptom severity over the course of treatment. The Children's Depression Inventory (CDI) total score ranges from 0 to 54. Higher scores indicate more severe depressive symptoms (worse outcome).
Measured: Baseline, Week 2, and Week 4
Change in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score
The SCARED is a self-report scale assessing symptoms of anxiety disorders in children and adolescents. Change in SCARED score reflects change in anxiety symptom severity over the course of treatment. The Screen for Child Anxiety Related Emotional Disorders (SCARED) total score ranges from 0 to 82. Higher scores indicate more severe anxiety symptoms (worse outcome).
Measured: Baseline, Week 2, and Week 4
Change in National Stressful Events Survey PTSD Short Scale (Child Version) (NSESSS) Total Score
The National Stressful Events Survey-PTSD Short Scale, Child Version (NSESSS), is a self-report scale assessing the severity of PTSD symptoms in children and adolescents following exposure to a traumatic event. Change in NSESSS score reflects change in PTSD symptom severity over the course of treatment. The National Stressful Events Survey PTSD Short Scale (Child Version) (NSESSS) total score ranges from 0 to 36. Higher scores indicate more severe PTSD symptoms (worse outcome).
Measured: Baseline, Week 2, and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start5 Jan 2025
- Primary completion10 Jun 2026
- Study completion27 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child Sexual AbuseStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sevda dabak, Ankara City Hospital Bilkent
- Investigators
- Sevda Dabak, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732335
- Sponsor's protocol ID
- TABED 1/808/2024
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: İngilizcesi: 'The study includes data from children and adolescents who are survivors of sexual abuse and who already constitute a clinically sensitive population. Due to the limited sample size (n=75) and the highly sensitive personal and clinical nature of the data, individual-level data carry a risk of re-identification even after full anonymization. To protect participant confidentiality and safety, individual patient data will not be shared with other researchers. In addition, the ethics committee approval obtained for this study does not cover the sharing of individual patient data with third parties.'
Publications
Tural Hesapcioglu S, Dabak S, Aburşu H, Ceylan MF. Intensive Inpatient Trauma-Focused Cognitive Behavioral Therapy (II-TF-CBT) for Child and Adolescent Survivors of Sexual Trauma in Psychiatric Inpatient Care. Ann Clin Psychiatry. 2026;37(3):113-126.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Intensive Inpatient Trauma-Focused Cognitive Behavioral Therapy (II-TF-CBT)
- ClinicalTrials.gov ID
- NCT07732335
- Acronym / sponsor ID
- TABED 1/808/2024
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 27 Jun 2026 (actual)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study looks at a treatment program for children and teens who have post-traumatic stress disorder (PTSD) after sexual abuse. The program is called II-TF-CBT. It is a special version of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), a type of cognitive behavioral therapy that helps people process trauma. II-TF-CBT is used with patients who stay in the hospital during treatment.
Researchers want to know if II-TF-CBT helps young patients recover as well as, or better than, standard outpatient treatment. Outpatient treatment means patients visit the clinic but do not stay overnight.
The study compares two groups. One group of 42 patients received II-TF-CBT during a hospital stay. The other group of 33 patients received standard outpatient treatment. Patients needing inpatient care were placed on an admission waiting list and admitted as their turn came; the remaining patients continued outpatient follow-up. Group placement therefore happened naturally, without researcher intervention.
Doctors measured each patient's PTSD symptoms and related problems before treatment, after treatment, and at a follow-up visit. This will help show whether inpatient TF-CBT-based care can help children and teens recover from trauma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| II-TF-CBT (Inpatient) | – | Behavioral: II-TF-CBTPatients hospitalized for treatment who received the II-TF-CBT protocol - an inpatient adaptation of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) that includes an added Intake phase prior to the standard TF-CBT components. Patients were admitted from a waiting list of children and adolescents requiring inpatient care for post-traumatic stress disorder (PTSD) following sexual abuse. Group assignment occurred naturally based on bed availability and admission order, not by researcher allocation. N=42. |
| Outpatient Follow-up (Control) | – | –Patients who continued standard outpatient treatment for PTSD following sexual abuse, without hospitalization. These patients remained on outpatient follow-up because they did not require or were not admitted for inpatient care. Group assignment occurred naturally based on clinical need, not by researcher allocation. N=33. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 'The study population consists of children and adolescents aged 11-17 years diagnosed with post-traumatic stress disorder (PTSD) according to DSM-5 criteria following sexual abuse, presenting to the inpatient and outpatient services of our clinic. Patients were enrolled over an 18-month period following ethics committee approval. Those clinically prioritized for hospitalization received inpatient treatment with the II-TF-CBT protocol; those with a similar clinical presentation who were awaiting inpatient admission continued outpatient follow-up during this period and formed the control group.'
Key inclusion criteria (5 listed)
- Age 11-17 years.
- Diagnosis of post-traumatic stress disorder (PTSD) according to DSM-5 criteria following sexual abuse.
- Admitted for inpatient treatment in the hospital's child and adolescent psychiatry inpatient unit within the 18-month enrollment period (II-TF-CBT group), or placed on the inpatient admission waiting list and followed in the outpatient clinic during the same period (outpatient control group).
- Patients meeting all eligibility criteria during the enrollment period were included.
- Assignment to the inpatient or outpatient control group was determined by clinical prioritization and admission order rather than by investigators.
Key exclusion criteria (6 listed)
- Age younger than 11 years or older than 17 years.
- Refusal to participate in the study.
- Schizophrenia or another active psychotic disorder.
- Current manic episode.
- Intellectual disability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| II-TF-CBTAn inpatient adaptation of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for children and adolescents with post-traumatic stress disorder following sexual abuse. The protocol follows the standard TF-CBT components (psychoeducation, relaxation, affect regulation, cognitive coping, trauma narrative, in vivo mastery, conjoint sessions, and safety enhancement), delivered during inpatient hospitalization. | Behavioural | II-TF-CBT (Inpatient) |
Primary outcome
Change in Clinical Global Impression-Severity (CGI-S) Score
Time frame: Baseline, Week 2, and Week 4)
The CGI-S is a clinician-rated scale assessing the overall severity of the patient's psychiatric symptoms on a 7-point scale, ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Change in CGI-S score over the course of treatment reflects overall clinical improvement in trauma-related symptom severity. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate greater illness severity (worse outcome).
3 secondary outcomes
Change in Children's Depression Inventory (CDI) Total Score
Time frame: Baseline, Week 2, and Week 4
Change in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score
Time frame: Baseline, Week 2, and Week 4
Change in National Stressful Events Survey PTSD Short Scale (Child Version) (NSESSS) Total Score
Time frame: Baseline, Week 2, and Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- BackgroundTural Hesapcioglu S, Dabak S, Aburşu H, Ceylan MF. Intensive Inpatient Trauma-Focused Cognitive Behavioral Therapy (II-TF-CBT) for Child and Adolescent Survivors of Sexual Trauma in Psychiatric Inpatient Care. Ann Clin Psychiatry. 2026;37(3):113-126.
- Individual participant dataSharing planned: No. İngilizcesi: 'The study includes data from children and adolescents who are survivors of sexual abuse and who already constitute a clinically sensitive population. Due to the limited sample size (n=75) and the highly sensitive personal and clinical nature of the data, individual-level data carry a risk of re-identification even after full anonymization. To protect participant confidentiality and safety, individual patient data will not be shared with other researchers. In addition, the ethics committee approval obtained for this study does not cover the sharing of individual patient data with third parties.'
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Partner
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevda Dabak, MD principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Sexual Abuse and Post-Traumatic Stress Disorder, PTSD, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Global Impression-Severity (CGI-S) Score (time frame: Baseline, Week 2, and Week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07732335, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.