Post-Traumatic Stress DisorderTCTNCT01516827
Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for Children With Post-traumatic Stress Disorder (TreatChildTrauma)
A study testing Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) in people with Post-Traumatic Stress Disorder, run by University of Ulm at 8 sites in Germany.
Trial summary
This multi-site randomized controlled trial compares the effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) as developed by Cohen, Mannarino \& Deblinger (2006) with a wait-list condition in a population of children aged 7-16 years who were exposed to traumatic events beyond the age of three years… Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 8 sitesGermany
- Study dates
- Feb 2012to Jun 2016
- Phase
- Interventional
- 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 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 7-16 years
- Exposure to a traumatic event (index trauma) after the age of 3 years, at least 3 months before assessment
- ≥35 points on the Clinician -Administered PTSD Scale for Children and Adolescents (CAPS-CA) total symptom severity score and at least one symptom per PTSD cluster related to the index trauma according to DSM IV diagnostic criteria
- PTSD should be the main mental health problem, patients with co-morbid mental disorders are included
- No major brain injury of the child due to the traumatic event (Glasgow Coma Scale <9 points at primary medical examination)
- Co-operation of at least one non-offending primary caregiver (improves treatment outcome)
- Living within reasonable distance (max 1 hour of travel) to the treatment center to allow treatment on a weekly basis (feasibility)
Who cannot join
- Psychosis
- Acute suicidality
- Psychopharmacological medication started or changed up to 6 weeks before first assessment
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Vivantes Klinik für Kinder- und Jugendpsychiatrie, Psychotherapie und Psychosomatik
Berlin, 13407
Vestische Kinder- und Jugendklinik Datteln
Datteln, 45711
Psychiatrische Klinik Lüneburg
Lüneburg, 21339
Klinik für Psychiatrie und Psychotherapie
Mannheim, 68072
Traumaambulanz LMU
München, 80802
ZfP Südwürttemberg Weissenau
Ravensburg, 88214
Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie
Saarbrücken, 66119
Universitätsklinikum Ulm
Ulm, 89075
About this study
Official title: Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for Children With Post-traumatic Stress Disorder
This multi-site randomized controlled trial compares the effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) as developed by Cohen, Mannarino \& Deblinger (2006) with a wait-list condition in a population of children aged 7-16 years who were exposed to traumatic events beyond the age of three years, at least three months ago, and developed Posttraumatic Stress Disorder (PTSD). Primary aims are to provide evidence that TF-CBT exceeds spontaneous remission of posttraumatic stress symptoms and to assess maintenance of treatment gains at 6 and 12 months post-treatment. Secondary aims are to evaluate the effectiveness of TF-CBT in reducing other psychopathology and cognitive distortions of patients and caregivers and to explore moderators and mediators of treatment response. The trial will contribute to implement an evidence-based treatment for traumatized children across a variety of healthcare settings in Germany. The novel aspect is to evaluate the effectiveness of TF-CBT with a broad range of traumatized "real-world" patients in the context of the German mental healthcare system.
Read the detailed description
Complete study protocol (in German) available from the PI lutz.goldbeck@uniklinik-ulm.de
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)
- Keywords
- PTSD, Children and Adolescents, Post-Traumatic Stress Disorder in Children and Adolescents
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)Behavioural
TF-CBT (see also HThttp://tfcbt.musc.eduTH) is a manualised intervention for traumatized children and adolescents 7 to 16 years old and their parent/caregiver. The primary components are summarized by the acronym PRACTICE: Parenting skills, Psychoeducation, Relaxation, Affect modulation, Cognitive processing, Trauma narrative, In vivo mastery of trauma reminders, Conjoint child-parent session, and Enhancing safety and future development. We will use the manual as provided by Cohen et al. and available in German. The treatment program will comprise 12 sessions with children and parents (partly separated, partly conjoined sessions) of 90 minutes each. The 12 sessions will be distributed over a duration of 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TF-CBT | Experimental | 12 Sessions Trauma-focused Cognitive Behavioral Therapy including the child/adolescents and a non-abusive caregiver according to the treatment manual:
Cohen JA, Mannarino AP, and Deblinger E (2006) Treating Trauma and Traumatic Grief in Children and Adolenscents. Guilford, N.Y. Receives: Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) |
| Wait-list | No intervention | Patients in the control condition will be assigned to a wait-list (duration 4 months). During waiting time, clinical services will be provided as needed (excluding TF-CBT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)
Symptom severity score
Measured: Change from Baseline at 16 weeks (=end of treatment)
Secondary outcomes (46)
Change from Baseline in Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL)
change in co-morbid psychiatric disorders
Measured: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Children's Global Assessment Scale (CGAS)
Global impairment
Measured: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Post-traumatic stress symptoms
Measured: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
Anxiety
Measured: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Children's Depression Inventory (CDI)
Depression
Measured: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
General Psychopathology
Measured: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
Quality of Life
Measured: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Trauma-related Cognitions (Child)
Measured: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Trauma-related cognitions (Parent)
Measured: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Parental symptoms: PTSD
Measured: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Beck Depression Inventory (BDI-II)
Parental Symptoms: Depression
Measured: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Parental symptoms: Anxiety
Measured: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Children's Global Assessment Scale (CGAS)
Global impairment
Measured: Change from Baseline at 6 months post-treatment
Change from Baseline in Children's Global Assessment Scale (CGAS)
Global impairment
Measured: Change from Baseline at 12 months post-treatment
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Measured: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Measured: Change rom Baseline at 6 months post-treatment
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Measured: Change from baseline at 12 months post-treatment
Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
Measured: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
Measured: Change from Baseline at 6 months post-treatment
Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
Measured: Change from Baseline at 12 months post-treatment
Change from Baseline in Children's Depression Inventory (CDI)
Measured: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Children's Depression Inventory (CDI)
Measured: Change from Baseline at 6 months post-treatment
Change from Baseline in Children's Depression Inventory (CDI)
Measured: Change from Baseline at 12 months post-treatment
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Measured: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Measured: Change from Baseline at 6 months post-treatment
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Measured: Change from Baseline at 12 months post-treatment
Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
Measured: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
Measured: Change from Baseline at 6 months post-treatment
Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
Measured: Change from Baseline at 12 months post-treatment
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Measured: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Measured: Change from Baseline at 6 months post-treatment
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Measured: Change from Baseline at 12 months post-treatment
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Measured: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Measured: Change from Baseline at 6 months post-treatment
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Measured: Change from Baseline at 12 months post-treatment
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Measured: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Measured: Change from Baseline at 6 months post-treatment
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Measured: Change from Baseline at 12 months post-treatment
Change from Baseline in Beck Depression Inventory (BDI-II)
Measured: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Beck Depression Inventory (BDI-II)
Measured: Change from Baseline at 6 months post-treatment
Change from Baseline in Beck Depression Inventory (BDI-II)
Measured: Change from Baseline at 12 months post-treatment
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Measured: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Measured: Change from Baseline at 6 months post-treatment
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Measured: Change from Baseline at 12 months post-treatment
Change from baselinein Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)
Symptom severity score
Measured: Change from Baseline at 6 monts post-treatment
Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)
Symptom severity score
Measured: Change from baseline at 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Lutz Goldbeck, University of Ulm
- Investigators
- Lutz Goldbeck, Ph.D., Principal investigator, University Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516827
- Sponsor's protocol ID
- TCT-001-ULM
- Acronym
- TCT
- Status last verified
- Oct 2017
- First submitted
- 13 Dec 2011
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tutus D, Pfeiffer E, Plener PL, Rosner R, Bernheim D, Sachser C. The Change in Parental Symptoms and Dysfunctional Cognitions in the Course of Trauma-Focused Cognitive-Behavioral Therapy: Sustainability Until One-Year Post-Treatment. J Child Adolesc Psychopharmacol. 2021 Mar;31(2):129-136. doi: 10.1089/cap.2020.0097. Epub 2020 Dec 23.
PubMed 33370208Lindebo Knutsen M, Sachser C, Holt T, Goldbeck L, Jensen TK. Trajectories and possible predictors of treatment outcome for youth receiving trauma-focused cognitive behavioral therapy. Psychol Trauma. 2020 May;12(4):336-346. doi: 10.1037/tra0000482. Epub 2019 Jul 25.
PubMed 31343205Tutus D, Goldbeck L, Pfeiffer E, Sachser C, Plener PL. Parental dysfunctional posttraumatic cognitions in trauma-focused cognitive behavioral therapy for children and adolescents. Psychol Trauma. 2019 Oct;11(7):722-731. doi: 10.1037/tra0000419. Epub 2018 Dec 20.
PubMed 30570287Sachser C, Keller F, Goldbeck L. Complex PTSD as proposed for ICD-11: validation of a new disorder in children and adolescents and their response to Trauma-Focused Cognitive Behavioral Therapy. J Child Psychol Psychiatry. 2017 Feb;58(2):160-168. doi: 10.1111/jcpp.12640. Epub 2016 Sep 28.
PubMed 27677771Unterhitzenberger J, Eberle-Sejari R, Rassenhofer M, Sukale T, Rosner R, Goldbeck L. Trauma-focused cognitive behavioral therapy with unaccompanied refugee minors: a case series. BMC Psychiatry. 2015 Oct 23;15:260. doi: 10.1186/s12888-015-0645-0.
PubMed 26497391
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for Children With Post-traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01516827
- Acronym / sponsor ID
- TCT / TCT-001-ULM
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- PTSD, Children and Adolescents, Post-Traumatic Stress Disorder in Children and Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Feb 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Jan 2012 (estimated)
- 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 multi-site randomized controlled trial compares the effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) as developed by Cohen, Mannarino \& Deblinger (2006) with a wait-list condition in a population of children aged 7-16 years who were exposed to traumatic events beyond the age of three years, at least three months ago, and developed Posttraumatic Stress Disorder (PTSD). Primary aims are to provide evidence that TF-CBT exceeds spontaneous remission of posttraumatic stress symptoms and to assess maintenance of treatment gains at 6 and 12 months post-treatment. Secondary aims are to evaluate the effectiveness of TF-CBT in reducing other psychopathology and cognitive distortions of patients and caregivers and to explore moderators and mediators of treatment response. The trial will contribute to implement an evidence-based treatment for traumatized children across a variety of healthcare settings in Germany. The novel aspect is to evaluate the effectiveness of TF-CBT with a broad range of traumatized "real-world" patients in the context of the German mental healthcare system.
Detailed description
Complete study protocol (in German) available from the PI lutz.goldbeck@uniklinik-ulm.de
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TF-CBT | Experimental | Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)12 Sessions Trauma-focused Cognitive Behavioral Therapy including the child/adolescents and a non-abusive caregiver according to the treatment manual: Cohen JA, Mannarino AP, and Deblinger E (2006) Treating Trauma and Traumatic Grief in Children and Adolenscents. Guilford, N.Y. |
| Wait-list | No intervention | –Patients in the control condition will be assigned to a wait-list (duration 4 months). During waiting time, clinical services will be provided as needed (excluding TF-CBT). |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 7-16 years
- Exposure to a traumatic event (index trauma) after the age of 3 years, at least 3 months before assessment
- ≥35 points on the Clinician -Administered PTSD Scale for Children and Adolescents (CAPS-CA) total symptom severity score and at least one symptom per PTSD cluster related to the index trauma according to DSM IV diagnostic criteria
- PTSD should be the main mental health problem, patients with co-morbid mental disorders are included
- No major brain injury of the child due to the traumatic event (Glasgow Coma Scale <9 points at primary medical examination)
Key exclusion criteria (3 listed)
- Psychosis
- Acute suicidality
- Psychopharmacological medication started or changed up to 6 weeks before first assessment
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 |
|---|---|---|
| Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)TF-CBT (see also HThttp://tfcbt.musc.eduTH) is a manualised intervention for traumatized children and adolescents 7 to 16 years old and their parent/caregiver. The primary components are summarized by the acronym PRACTICE: Parenting skills, Psychoeducation, Relaxation, Affect modulation, Cognitive processing, Trauma narrative, In vivo mastery of trauma reminders, Conjoint child-parent session, and Enhancing safety and future development. We will use the manual as provided by Cohen et al. and available in German. The treatment program will comprise 12 sessions with children and parents (partly separated, partly conjoined sessions) of 90 minutes each. The 12 sessions will be distributed over a duration of 16 weeks. | Behavioural | TF-CBT |
Primary outcome
Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Symptom severity score
46 secondary outcomes
Change from Baseline in Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Children's Global Assessment Scale (CGAS)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Time frame: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
Time frame: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Children's Depression Inventory (CDI)
Time frame: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Time frame: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
Time frame: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Time frame: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Time frame: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Time frame: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Beck Depression Inventory (BDI-II)
Time frame: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in State-Trait-Anxiety-Inventory (STAI)
Time frame: Change from Baseline at 8 weeks (=mid-treatment)
Change from Baseline in Children's Global Assessment Scale (CGAS)
Time frame: Change from Baseline at 6 months post-treatment
Change from Baseline in Children's Global Assessment Scale (CGAS)
Time frame: Change from Baseline at 12 months post-treatment
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Time frame: Change rom Baseline at 6 months post-treatment
Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)
Time frame: Change from baseline at 12 months post-treatment
Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
Time frame: Change from Baseline at 6 months post-treatment
Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)
Time frame: Change from Baseline at 12 months post-treatment
Change from Baseline in Children's Depression Inventory (CDI)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Children's Depression Inventory (CDI)
Time frame: Change from Baseline at 6 months post-treatment
Change from Baseline in Children's Depression Inventory (CDI)
Time frame: Change from Baseline at 12 months post-treatment
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Time frame: Change from Baseline at 6 months post-treatment
Change from Baseline in Child Behavior Checklist (CBCL 4/18)
Time frame: Change from Baseline at 12 months post-treatment
Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
Time frame: Change from Baseline at 6 months post-treatment
Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)
Time frame: Change from Baseline at 12 months post-treatment
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Time frame: Change from Baseline at 6 months post-treatment
Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)
Time frame: Change from Baseline at 12 months post-treatment
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Time frame: Change from Baseline at 6 months post-treatment
Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)
Time frame: Change from Baseline at 12 months post-treatment
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Time frame: Change from Baseline at 6 months post-treatment
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)
Time frame: Change from Baseline at 12 months post-treatment
Change from Baseline in Beck Depression Inventory (BDI-II)
Time frame: Change from Baseline at 16 weeks (=end of treatment)
Change from Baseline in Beck Depression Inventory (BDI-II)
Time frame: Change from Baseline at 6 months post-treatment
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 27 Oct 2017.
- Derived from this study: PubMed 33370208Tutus D, Pfeiffer E, Plener PL, Rosner R, Bernheim D, Sachser C. The Change in Parental Symptoms and Dysfunctional Cognitions in the Course of Trauma-Focused Cognitive-Behavioral Therapy: Sustainability Until One-Year Post-Treatment. J Child Adolesc Psychopharmacol. 2021 Mar;31(2):129-136. doi: 10.1089/cap.2020.0097. Epub 2020 Dec 23.
- Derived from this study: PubMed 31343205Lindebo Knutsen M, Sachser C, Holt T, Goldbeck L, Jensen TK. Trajectories and possible predictors of treatment outcome for youth receiving trauma-focused cognitive behavioral therapy. Psychol Trauma. 2020 May;12(4):336-346. doi: 10.1037/tra0000482. Epub 2019 Jul 25.
- Derived from this study: PubMed 30570287Tutus D, Goldbeck L, Pfeiffer E, Sachser C, Plener PL. Parental dysfunctional posttraumatic cognitions in trauma-focused cognitive behavioral therapy for children and adolescents. Psychol Trauma. 2019 Oct;11(7):722-731. doi: 10.1037/tra0000419. Epub 2018 Dec 20.
- Derived from this study: PubMed 27677771Sachser C, Keller F, Goldbeck L. Complex PTSD as proposed for ICD-11: validation of a new disorder in children and adolescents and their response to Trauma-Focused Cognitive Behavioral Therapy. J Child Psychol Psychiatry. 2017 Feb;58(2):160-168. doi: 10.1111/jcpp.12640. Epub 2016 Sep 28.
- Derived from this study: PubMed 26497391Unterhitzenberger J, Eberle-Sejari R, Rassenhofer M, Sukale T, Rosner R, Goldbeck L. Trauma-focused cognitive behavioral therapy with unaccompanied refugee minors: a case series. BMC Psychiatry. 2015 Oct 23;15:260. doi: 10.1186/s12888-015-0645-0.
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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.
Lutz Goldbeck, Ph.D. principal investigator
University Ulm
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) in people with Post-Traumatic Stress Disorder, run by University of Ulm at 8 sites in Germany.
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 7 inclusion and 3 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 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. 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 from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA) (time frame: Change from Baseline at 16 weeks (=end of treatment)). 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 NCT01516827, which also lists 5 linked publications.
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 27 Oct 2017.