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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03719651
Other study ID # LOCI Norway
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2018
Est. completion date December 31, 2020

Study information

Verified date March 2021
Source Norwegian Center for Violence and Traumatic Stress Studies
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The project will develop knowledge on how managers can lead the implementation of practices that have proven to be effective for post-traumatic stress disorders (PTSD) in child and adult specialized mental health services. Specifically, the project will test the effectiveness of an intervention named the Leadership and Organizational Change for Implementation (LOCI). This is an empirically and theoretically based innovation for implementation leadership that aims to support leaders in their organizational work of leading the implementation of EBPs in their clinics. It is hypothesized that the implementation of LOCI will improve leaders' general leadership qualifications, their implementation leadership qualifications, and the implementation climate in the clinics. Further, the investigators hypothesize that training in trauma screening will increase the amount of trauma screenings, moderated by the LOCI implementation, and also that training in trauma treatment will increase the amount of patients to be offered this kind of treatment, also moderated by the LOCI implementation.


Description:

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Study Design


Intervention

Behavioral:
LOCI
LOCI includes training of leaders in general leadership, implementation leadership, and implementation climate.
EMDR
EMDR (Eye Movement and Desensitization Reprocessing), treatment method developed for treating patients with Post-Traumatic Stress Symptoms (PTSD).
CT-PTSD
CT-PTSD (Cognitive Therapy for PTSD), treatment method developed for treating patients with Post-Traumatic Stress Symptoms (PTSD).
TF-CBT
TF-CBT (Trauma-Focused Cognitive-Behavioral Treatment) treatment method developed for treating patients with Post-Traumatic Stress Symptoms (PTSD).

Locations

Country Name City State
Norway Karina Egeland Oslo

Sponsors (1)

Lead Sponsor Collaborator
Norwegian Center for Violence and Traumatic Stress Studies

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Implementation Leadership Scale (ILS) ILS assesses the degree to which leaders are knowledgeable, proactive, perseverant, and supportive during evidence-based practice (EBP) implementation.Scored from 0 (not at all) to 4 (to a very great extent). 4 weeks
Secondary Number of trauma assessments and patients that receive trauma treatment. Practitioners are asked to report the number of trauma assessments done within the last 4 months. The practitioners that have been trained in either TF-CBT, EMDR or CT-PTSD will also be asked to report the number of patients that receive the specific treatment. 12 months
Secondary The Multifactor Leadership Questionnaire (MLQ) A 36-item measure addressing transformational and transactional leadership. Scored from 0 (not at all) to 4 (frequently, if not always) 12 months
Secondary The Implementation Climate Scale (ICS) An 18-item measure addressing to what extent an organization support the implementation of EBP. Scored from 0 (not at all) to 4 (to a very great extent). 12 months
Secondary The Implementation Climate (IC) A 6-item measure addressing the implementation climate in the organization. Scored from 0 (not at all) to 4 (often, if not always). 12 months
Secondary Workload (QPS) Thirteen items from the QPS Nordic questionnaire. Coping with work (6 items), job demands (7 items). Scored from 1 (very seldom or never) to 5 (very often or always). 12 months
Secondary The Implementation Citizenship Behavior Scale (ICBS) A six-item measure addressing employee behaviour that goes beyond their duty to support the implementation of EBP. Scored from 0 (Not at all) to 4 (Frequently, if not always). 12 months
Secondary TF-CBT Fidelity Evaluating whether the therapist carries out the manual correctly. Developed for this Project. 12 months
Secondary The Treatment integrity checklist for EMDR (T-TIP EMDR) consists of 16 items evaluating whether the therapist carries out the manual correctly ("yes" or "not relevant" = 1 point, "no" = 0 point). Maximal score is 16 points. 12 months
Secondary Cognitive Therapy for Post-Traumatic Stress Disorder: A Checklist of Therapist Competency consists of 16 items evaluating therapists' general and specific therapeutic skills on a range between 0 (poor) and 6 (excellent) 12 months
Secondary The Child & Adolescent Trauma Screening Questionnaire (CATS) 20 symptom items and 5 functional impairment items. A total symptom severity scale score ranging from 0 to 60 is calculated. Screening cut off point is 15. 12 months
Secondary Stressful Life Events Screening Questionnaire - revised (SLESQ) 15 questions on stressful life events (0 = no, 1 = yes) 12 months
Secondary PTSD Checklist (PCL-5) 20 symptom items. A total symptom severity scale score ranging from 0 to 80. (0 = not at all, 4 = a lot) 12 months
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