An interventional study of CBITS and TAU+ in Posttraumatic Stress Disorder, sponsored by University Hospital Ulm. Not yet recruiting. Open to participants aged 8 Years to 16 Years. Per ClinicalTrials.gov, last updated 2023-09-14.
Sponsored by University Hospital Ulm · Not applicable, Interventional, and Treatment
The goal of this randomized controlled trial is to evaluate the effectiveness of the trauma-focused group intervention CBITS compared with enhanced treatment as usual (TAU+) in child welfare programs in Germany. The target group are traumatized children and adolescents in out-of-home care who report posttraumatic stress symptoms (PTSS).
The study objectives are
Participants and their caregivers will complete questionnaires at three measurement time points. Weekly PTSS symptom monitoring during treatment and alliance ratings (participants and therapists) at the beginning and the end of the intervention will be implemented. Trained therapists at three study centers (Marburg, Ulm, Bochum) will complete questionnaires before their training and after CBITS implementation. Site monitoring and auditing, as well as reliability checks of the data will be conducted by an independent data manager. Randomization will be implemented by an independent Institute at Ulm University. Standard Operating Procedures (SOPs) to address patient recruitment, data collection, data management, reporting for adverse events, and change management will be provided. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect were performed via the program G-Power, in collaboration with an independent statistical advisor, before proposal submission. A plan for missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results are prepared in collaboration with the independent statistical advisor. We will following Intention-to-treat (ITT) principles in our analyses. The statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, are specified in the study protocol which will be published before data collection.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 90 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →University Hospital Ulm is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cognitive Behavioral Intervention for Trauma in Schools (CBITS)
Behavioral: CBITS
Enhanced Treatment as Usual means regular care in child welfare program and mental health care. They also receive feedback on their assessments and a treatment recommendation.
Other: TAU+
The CBITS program is a skills-based group and individual intervention, which uses evidence-based cognitive-behavioral techniques (e.g. psychoeducation, relaxation, social problem solving, cognitive restructuring, and exposure) and is designed for delivery by mental health professionals. The program consists of 10 45-minute group sessions (about 6-8 students/participants per group), 1-3 individual sessions, 2 parent/caregiver psychoeducational sessions, and 1 teacher/ child welfare staff educational session. For this study, we will specifically train and supervise study therapists to deliver the intervention within child welfare programs.
Also known as: Cognitive Behavioral Intervention for Trauma in Schools
In the control condition (TAU+), child welfare programs will follow their usual procedures (i.e. routine care of child welfare, referral to medical practitioners and psychotherapists, handling of prescribed medication, referral to inpatient treatments in case of risk to self and others) which reflects treatment as usual in child welfare programs and the mental health care system in Germany. Additionally, participants in the control condition will receive the same baseline assessment and reporting of screening results as participants in the treatment condition after each assessment.
Child and Adolescent Trauma Screen - Second Version (CATS-2 self-report)
The CATS-2 is a questionnaire to screen for potentially traumatic events and assesses symptoms of PTSD/Complex-PTSD (CPTSD) (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and International Classification of Diseases Version 11 (ICD-11)) in children and adolescents. The minimal score value is "0", the maximum score value is "60", while higher scores mean a worse outcome.
Time frame: baseline, 4-month follow-up, 10-month follow-up (primary endpoint 4-months follow up)
Revised Child Anxiety and Depression Scale (RCADS) (self-and caregiver report)
The RCADS is a 47-item, self- and caregiver-report questionnaire with subscales including: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). For the anxiety subscale the minimum score value is "0", the maximum score value is "111", while higher scores mean more anxiety. For the depression subscale the minimum score value is "0", the maximum score value is "30", while higher scores mean worse depressive symptoms. Therefore, the minimum score value is "0", the maximum score value is "141", while higher scores mean a worse outcome.
Time frame: baseline, 4-month follow-up, 10-month follow-up
Screening and Promotion of Children and Adolescents Health: A European Public Health Perspective (KIDSCREEN questionnaire) (self-and caregiver report)
Quality of life will be assessed via the KIDSCREEN-10 which is a generic health related quality of life measure. The minimum score value is "10", the maximum score value is "50", while higher scores mean a better quality of life.
Time frame: baseline, 4-month follow-up, 10-month follow-up
Child and Adolescent Trauma Screen - Second Version (CATS-2 caregiver-report)
corresponding measure to CATS-2 self-report, completed by the participants' caregivers. The minimum score value is "0", the maximum score value is "60", while higher scores mean a worse outcome.
Time frame: baseline, 4-month follow-up, 10-month follow-up
Children's Global Assessment Scale (CGAS Caregiver-report)
The level of functioning will be assessed via the CGAS. The minimum score value is "1", the maximum score value is "100", while higher scores mean a higher functioning level.
Time frame: baseline, 4-month follow-up, 10-month follow-up
Non-standardized quantitative questionnaire to collect study feedback
Via a non-standardized quantitative questionnaire, participants, caregivers, and therapists will be asked about their experiences with the overall study and the CBITS intervention. The questionnaire for participants consists of 13 Items. The minimum score value is "0", the maximum score value is "65". A higher score means a better Feedback. The questionnaire for the caregivers consists of 9 Items. 7 of them can be rated on a Likert-Scale. The minimum score value is "7", the maximum score value is "42". Higher scores mean a worse feedback. The questionnaire for the therapists consists of 19 Items. 6 can be rated on a Likert-Scale. The minimum score value is "6", the maximum score value is "36", while higher scores mean a worse feedback.
Time frame: 4-month follow-up, 10-month follow-up
Non-standardized qualitative interview to collect study feedback
Via non-standardized qualitative interview using 13 items the participants, caregivers and therapists will be asked about their overall experiences during the study and the CBITS intervention.
Time frame: 4-month follow-up, 10-month follow-up
Child and Adolescent Mental Health Service Receipt Inventory - German (CAMHSRI-German caregiver-report)
Use of medical, psychosocial and child welfare services in both conditions will be assessed in a standardized manner by the CAMHSRI-DE. Completed by the caregivers.
Time frame: baseline, 4-month follow-up, 10-month follow-up
Implementation Climate Scale (ICS Caregiver-report)
The ICS is an 18-item questionnaire measuring the degree to which the organizational climate is supportive of evidence-based practice (EBP) implementation. The items form six subscales including focus on EBP, educational support for EBP, recognition for EBP, rewards for EBP, selection for EBP and selection for openness. The minimum score value for every subscale and in total is "0", the maximum score value is "4", while higher scores indicate a better fit of the intervention in the environment.
Time frame: baseline
Evidence-Based Practice Attitude Scale (EBPAS-36 Caregiver-report)
The EBPAS-36 is a 36-item questionnaire assessing attitudes of mental health providers towards the adoption of EBP. The items form 12 subscales (requirements, appeal, openness, divergence, limitations, fit, monitoring, balance, burden, job security, organizational support, feedback). The minimum score value for every subscale and in total is "0", the maximum score value is "4", while higher scores indicate a better attitude towards evidence-based practice.
Time frame: baseline
CBITS original adherence and fidelity measure
The therapist adherence and fidelity will be assessed by the CBITS Adherence/Fidelity measure which is a 4 Item scale. The minimum score value is "0", the maximum is "3", while higher scores mean that the topic has been thoroughly covered.
Time frame: through study completion, an average of 10 weeks
Child and Adolescent Trauma Screen - Second and Short Version (CATS-2 self-report)
At the beginning of every CBITS session, the participants complete a short version of the CATS-2 symptom screener. The minimum score value is "0", the maximum score value is "21", while higher scores mean a worse outcome.
Time frame: through study completion, an average of 10 weeks
Therapeutic Alliance Scales for Children - Revised (TASC-r)
The working alliance between therapists and participants will be assessed via TASC-r (questions on therapist and group alliance). The measure will be completed by the participants and therapists. The minimum score value is "0", the maximum score value is "4", while higher scores mean a better outcome.
Time frame: through study completion, an average of 10 weeks
Inventory for the Assessment of Negative Effects of Psychotherapy for children and adolescents (Children-INEP) (self-and caregiver report)
The Children-INEP is an 18-item questionnaire (12 items on subscale "negative effects" and 6 items on subscale "unethical behavior and malpractice") which assesses unwanted side effects in psychotherapy after several months post-treatment via self-and care-giver report. The minimum score value for the subscale negative effects is "0", the maximum score values is "12", while higher rates mean more negative side effects. The items for the subscale unethical behavior and malpractice will be rated on individual item level with a minimum score value of "1" and maximum score value of "4" for each item. Higher scores are worse therapeutic behaviors.
Time frame: 4-month follow-up, 10-month follow-up
No study locations are listed for this record.
Plan to share: Yes — Yes - Individual participant data (IPD) will be made available to other researchers on request, after publication of the main results and after data sharing agreements are concluded. All IPD that underlie results in a publication will be shared. The study protocol and statistical analysis plan will be shared. IPD and additional supporting information will become available for 2 years once summary data is published. Requests for IPD data and additional supporting information will be reviewed by the leaders of the project (E. Pfeiffer and C. Sachses). There is no web address about the plan to share IPD available.
Start is estimated for Nov 2023; primary completion for Oct 2025, 23 months later.
Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 23 months is below that.
Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic →
University Hospital Ulm