NCT07732335

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2026

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2026

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

1.4 years

First QC Date

July 24, 2026

Last Update Submit

July 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline, Week 2, and Week 4)

Secondary Outcomes (3)

  • Change in Children's Depression Inventory (CDI) Total Score

    Baseline, Week 2, and Week 4

  • Change in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score

    Baseline, Week 2, and Week 4

  • Change in National Stressful Events Survey PTSD Short Scale (Child Version) (NSESSS) Total Score

    Baseline, Week 2, and Week 4

Study Arms (2)

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.

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.

Interventions

II-TF-CBTBEHAVIORAL

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.

II-TF-CBT (Inpatient)

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.'

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yenimahalle Training and Research Hospital

Ankara, Ankara, 06370, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Combat Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Sevda Dabak, MD

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician, Child and Adolescent Psychiatry

Study Record Dates

First Submitted

July 24, 2026

First Posted

July 28, 2026

Study Start

January 5, 2025

Primary Completion

June 10, 2026

Study Completion

June 27, 2026

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.'

Locations