Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Depressive Symptoms
  • Health Related Quality of Life
  • Parental Stress
  • Post Traumatic Stress Disorder (PTSD)
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Upon training in SC-TF-CBT, therapists in Norwegian municiplaities across the country will administer the treatment as deemed appropriate. Data will be collected to determine feasibility.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 7 years and 12 years
Gender
Both males and females

Description

Stepped-Care Trauma-Focused Behavioral Cognitive Therapy (SC-TF-CBT) is a semi home-based treatment for children at risk of developing PTSD, where the child's caregiver takes on the role as helper under the guidance of a trained therapist. The treatment runs over a course of approximately 12-15 week...

Stepped-Care Trauma-Focused Behavioral Cognitive Therapy (SC-TF-CBT) is a semi home-based treatment for children at risk of developing PTSD, where the child's caregiver takes on the role as helper under the guidance of a trained therapist. The treatment runs over a course of approximately 12-15 weeks and has two phases. In cases where symptom improvement is evident after 6-9 weeks, the following 6 weeks is a maintenance phase. In the maintenance phase, the child and caregiver will continue with some of the exercises found helpful and engage in pleasant activities together, while receiving follow-ups by the therapist. In cases where symptoms persist, however, the treatment is stepped up to TF-CBT. In the Norwegian context, in contrast to the US, stepping up will imply that responsibility for the treatment is transferred from the municipal service level to a Child and Youth Psychiatric Policlinic (BUP). In this particular way, the treatment scheme is adapted to the local context, while ensuring continuity as intended by the developers. Examining how this transition is experienced, how the transition is reasoned for and organized, and the transitions correspond with treatment needs are therefore important objectives. The first stage of this trial project involves providing SC-TF-CBT training to 45 therapists (primarily clinical psychologists with experience in trauma treatment and working with children/ families) in the 15 municipalities across Norway. Training is carried out by specialists in psychology at NKVTS in collaboration with the University of South Florida (USF). Following the training, the therapists will receive referrals as usual, but will be equipped with an additional treatment method. While protocols exist for two age categories (3-6 and 7-12), this project focuses on children between the ages of 7-12. In total, about 75 children (and caregivers) will participate in the study. This estimate takes into account a possible dropout rate of about 30 percent. In order to produce sufficiently strong analysis, including mediator analysis, the investigators' calculations indicate that the study requires 58 children to complete the SC-TF-CBT program. Caregivers and children participating in the study will be asked to provide information about symptoms and treatment experiences at several points throughout the treatment trajectory. The therapist will collect information by way of assessment forms available for completion on iPads. The therapists will also submit evaluations throughout the trajectory of each family by way of online assessment forms and 3 months after treatment completion. Audio recordings from treatment session will be used to determine fidelity. To attain data on entire trajectories, from pre-screening through completed treatments, the quantitative data will be supplemented by qualitative, semi-structured interviews with children, caregivers, and therapists. The interviews are to take place upon treatment completion, after approximately 12-15 weeks. A similar time-frame will be adopted for interviews with families transferred to the specialist service level, who will complete one interview after completion/interruption of Step 1, and then a short second interview 12 weeks after starting treatment in specialist health services, to explore the experiences with the transition. Additionally, to assess the long-term effects of the treatment, the investigators will invite a sample of children and caregivers for follow-up interviews 3-4 months after completion.

Tracking Information

NCT #
NCT04073862
Collaborators
University of South Florida
Investigators
Principal Investigator: Ingeborg Skjærvø, PhD Norwegian Center for Violence and Traumatic Stress Studies