Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2025-12-17 @ 12:47 PM
Study NCT ID:
NCT06038357
Status:
None
Last Update Posted:
2023-09-14 00:00:00
First Post:
2023-07-24 00:00:00
Brief Title:
CBITS - Treat Trauma in Child Welfare
Sponsor:
University Hospital Ulm
Organization:
University Hospital Ulm
Study Overview
Official Title:
Evaluation of "Cognitive Behavioral Intervention for Trauma in Schools" (CBITS) in Child Welfare Programs in Germany: A Randomized Controlled Trial
Status:
None
Status Verified Date:
2023-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CBITS
Brief Summary:
The study objectives are
1. Evaluate the effectiveness of CBITS compared to TAU+ regarding PTSS symptom reduction (primary outcome), anxiety, depression, quality of life and functional level, and continuance of the child welfare program (secondary outcomes) at 4-month follow-up
2. Investigate potential long-term effects of the treatment in the CBITS condition regarding the primary and secondary outcomes at 10-month follow-up.
3. Implement CBITS as an outreach intervention into routine mental health care for traumatized children, to evaluate treatment fidelity, treatment completion and investigate different potential individual or structural factors that might have an impact on the implementation.
4. To assess the readiness in child welfare programs to collaborate with mental health services and the role of institutional environments for developmental trajectories.
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.
1. Evaluate the effectiveness of CBITS compared to TAU+ regarding PTSS symptom reduction (primary outcome), anxiety, depression, quality of life and functional level, and continuance of the child welfare program (secondary outcomes) at 4-month follow-up
2. Investigate potential long-term effects of the treatment in the CBITS condition regarding the primary and secondary outcomes at 10-month follow-up.
3. Implement CBITS as an outreach intervention into routine mental health care for traumatized children, to evaluate treatment fidelity, treatment completion and investigate different potential individual or structural factors that might have an impact on the implementation.
4. To assess the readiness in child welfare programs to collaborate with mental health services and the role of institutional environments for developmental trajectories.
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.
Detailed Description:
The study objectives are
1 Evaluate the effectiveness of CBITS compared to TAU regarding PTSS symptom reduction primary outcome anxiety depression quality of life and functional level and continuance of the child welfare program secondary outcomes at 4-month follow-up
2 Investigate potential long-term effects of the treatment in the CBITS condition regarding the primary and secondary outcomes at 10-month follow-up
3 Implement CBITS as an outreach intervention into routine mental health care for traumatized children to evaluate treatment fidelity treatment completion and investigate different potential individual or structural factors that might have an impact on the implementation
4 To assess the readiness in child welfare programs to collaborate with mental health services and the role of institutional environments for developmental trajectories
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
1 Evaluate the effectiveness of CBITS compared to TAU regarding PTSS symptom reduction primary outcome anxiety depression quality of life and functional level and continuance of the child welfare program secondary outcomes at 4-month follow-up
2 Investigate potential long-term effects of the treatment in the CBITS condition regarding the primary and secondary outcomes at 10-month follow-up
3 Implement CBITS as an outreach intervention into routine mental health care for traumatized children to evaluate treatment fidelity treatment completion and investigate different potential individual or structural factors that might have an impact on the implementation
4 To assess the readiness in child welfare programs to collaborate with mental health services and the role of institutional environments for developmental trajectories
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None