The Norwegian Stepped-Care TF-CBT Study
Condition: Post Traumatic Stress Disorder (PTSD); Depressive Symptoms; Parental Stress; Health Related Quality of Life
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Depression
Study type: Interventional

Summary: 
      Every day, a significant number of children and young people in Norway experience violence,
      abuse, or other potentially traumatizing events. These children are at risk of developing
      serious health problems such as post-traumatic stress disorder (PTSD), anxiety, depression,
      behavioral problems, and drug dependency. Moreover, when left unaddressed, trauma experiences
      in childhood can have long-term implications for work- and educational participation as well
      as later subjection to violence. Provision of accessible and situationally adaptable
      treatments can therefore have great benefits for children, families, and communities at
      large.

      In this project, the investigators will introduce the method of Stepped-Care Trauma-Focused
      Behavioral Cognitive Therapy (SC-TF-CBT) in a selection of 15 municipalities across Norway.
      SC-TF-CBT is a parent-led - therapist-assisted low-threshold method aimed at treating
      children exposed to abuse, sexual assault, or other trauma and who are at risk of developing
      more severe trauma-related difficulties (Salloum, et al. 2014). This is the first test of the
      method outside the US. The project's main aim is therefore to evaluate the feasibility and
      efficiency of the treatment in a Norwegian context through a pre-post design.

      The following questions are to be explored:

        1. How does the SC-TF-CBT model fit the Norwegian health care culture and service system?

        2. When testing Stepped-Care in a Norwegian context, the model is set to involve both the
           municipal and specialist service levels. Severe cases will be stepped up/transferred to
           the specialist level for TF-CBT treatment. How do these transitions work for the
           participating families, and what are the experiences and perspectives of practitioners
           and service-leaders regarding coordination and collaboration between service levels?

        3. Do the children, parents, and therapists like working with the method?

        4. Do recipients of the treatment (children and parents) report symptom improvement?

        5. Which children and parents seem to benefit the most from the method, and who do not?
    

Detailed 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 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 80 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 analyses, the
      investigators' calculations indicate that the study requires 58 children to complete the
      SC-TF-CBT program. Based on current data and rate of missingness, the earlier estimate of 75
      participants has been changed to 80 (Nov.2021).

      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.

      Hypotheses:

      For research questions 1-3 we expect that most children, caregivers, therapists, and
      municipality leaders will find the model suitable and acceptable, however, we also expect
      that some aspects will be perceived as challenging, and that there may be need for
      adjustments in both the material and strategy for implementation.

      For research question 4, it is hypothesized that:

        -  Children will report lower symptom levels (PTSS, depressive symptoms) and better
           functioning and quality of life (CGI, 17D) after the completion of step one.

        -  Parents will report lower symptom levels (PTSS, anxiety, depression), reduced parental
           stress, and increase in positive aspects of being a parent after the completion of step
           one.

      For research question 5 it is hypothesized that:

        -  Children exposed to several traumatic events will be at higher risk of non-response
           compared to children exposed to fewer traumatic events.

        -  Children exposed to interpersonal trauma will be at higher risk of non-response compared
           to children exposed to non-interpersonal trauma.

        -  Higher levels of child PTSS, depression, and posttraumatic cognitions pre-treatment
           predicts non-response.

        -  Higher levels of parents' PTSS, anxiety, depression, and negative emotional reactions
           related to the child's trauma pre-treatment will predict dropout and non-response.

        -  Lower levels of parents' perceived social support and less percceived positive aspects
           of being a parent pre-treatment will predict dropout and non-response.

        -  More barriers and lower expectations to the treatment by parents will predict dropout
           and non-response.

        -  Changes in parents' mental health (PTSS, anxiety, depression), emotional reactions and
           perceived positive aspects of being a parent will predict subsequent change in the
           child's general functioning, depressive symptoms, and quality of life, but will not
           predict changes in child's level of PTSS.
    

Intervention name(s): Stepped-Care TF-CBT
Intervention type(s): Other
Intervention description(s): SC-TF-CBT will be administered to children meeting the inclusion criteria of the study. The treatment aims to improve daily function for trauma-exposed children and their families by way of stress-mastery exercises, coping skills and gradual exposure.
Intervention model: Single Group Assignment
Intervention 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
Keywords: Stepped-Care Trauma-Focused Cognitive Behavioral Therapy