Clinical trial NCT04073862: The Norwegian Stepped-Care TF-CBT Study
Official title: Assessing Feasibility of Stepped Care TF-CBT in Norwegian Municipalities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder (PTSD)
Depressive Symptoms
Parental Stress
Health Related Quality of Life
Keywords: Stepped-Care Trauma-Focused Cognitive Behavioral Therapy
Lead sponsor: Norwegian Center for Violence and Traumatic Stress Studies
Sponsor class: OTHER
Collaborators: name: University of South Florida
First posted: 2019-08-29
Enrollment: 82
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Age 7-12
2. Exposure to at least one episode of violence or other potentially traumatizing event
3. At least 3 years old at time of trauma
4. Minimum 5 symptoms of PTSS (i.e., a frequency score of 2 or 3 on the CATS) of which at least 1 symptom is reexperiencing and 1 symptom is avoidance
5. The therapist must talk to the child alone to make sure that the child is safe at home (see exclusion criteria)
6. At least one month has passed since the last traumatic event.

In addition:

A. If two or more siblings fulfill the inclusion criteria, only the youngest should be included in the study

Exclusion Criteria:

1. Suspicions of psychosis, mental retardation, autism spectrum disorder in the child or any condition that would limit the caregiver's ability to understand CBT and the child's ability to follow instructions.
2. Not fluent in Norwegian and needs interpreter to complete treatment
3. The caregiver who would be treatment participant was the perpetrator, or perpetrator still living at home
4. Parent has had substance use disorder (SUD) within the past 3 months.
5. Child or caregiver is suicidal
6. If child is taking psychotropic medication regimen must be stable for 4 weeks. However, for stimulants or benzodiazepines, the medication regimen must be stable for 2 weeks.
7. Child is currently receiving an other type of trauma treatment

Primary outcomes:
measure: CATS 2.0 (Children version / Caregiver version) - Assessment of Change in Symptoms
timeFrame: Baseline (T0), 6-9 weeks (T2), 12-15 weeks (T3), 24-27 weeks (T4)
Secondary outcomes:
measure: Quality of life in pre-adolescence: a 17-dimensional health-related measure (17D)
timeFrame: T1 (start-up), 6-9 weeks (T2), T3 (12-15 weeks), 24-27 weeks (T4)
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Baseline (T0)
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Baseline (T0)
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Baseline (T0)
measure: Child and Adolescent Social Support Scale (CASSS 2000)
timeFrame: T1 (start-up), T2 (6-9 weeks), T3 (12-15 weeks), 24-27 weeks (T4)
measure: Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
timeFrame: T1 (day of treatment start-up), T2 (6-9 weeks), T3 (12-15 weeks), 24-27 weeks (T4)
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: T3 (12-15 weeks) or before if treatment ends early.
measure: Clinical Global Impression - Severity (CGI-S) and Clinical Global Impression - Improvement (CGI-I)
timeFrame: CGI-S: T0 (baseline), T2 (6-9 weeks), T3 (12-15 weeks). CGI-I: T1 (start-up), P2 (2 weeks), P3 (4 weeks), T2 (6-9 weeks), T3 (12-15), 24-27 weeks (T4). CGI-I from caregiver only collected during 7 telephonecalles inbetween sessions with the therapist.
measure: Expectancy Rating Form (ERF)
timeFrame: T1 (at treatment start-up)
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: T1 (start-up), T2 (6-9 weeks), T3 (12-15 weeks), T4 (24-27 weeks)
measure: Parental Emotional Response Questionnaire (PERQ)
timeFrame: T1 (start-up), T2 (6-9 weeks), T3 (12-15 weeks), 24-27 weeks (T4)
measure: Parental Stress Scale (PSS)
timeFrame: T1 (start-up), T2 (6-9 weeks), T3 (12-15 weeks), 24-27 weeks (T4)
measure: Pediatric Symptom Checklist (PSC-17)
timeFrame: T1 (start-up), T2 (6-9 weeks), T3 (12-15 weeks), 24-27 weeks (T4)
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: T1 (start-up), T2 (6-9 weeks), T3 (12-15 weeks), 24-27 weeks (T4)
measure: Short Moods and Feeling Questionnaire (SMFQ)
timeFrame: T1 (start-up), T2 (6-9 weeks), T3 (12-15 weeks)
measure: Stressful Life-Events Screening Questionnaire (SLESQ)
timeFrame: T1 (start-up), T2 (6-9 weeks), T3 (12-15 weeks), 24-27 weeks (T4)
measure: Symptom Check-list-10 (SCL-10)
timeFrame: T1 (start-up), T2 (6-9 weeks), T3 (12-15 weeks), 24-27 weeks (T4)
measure: Therapeutic Alliance Scale for Children (TASC): Therapist-Caregiver
timeFrame: P1 (after first session), P2 (2 weeks), P3 (4 weeks), P4/T2 (6-9 weeks)
measure: Therapeutic Alliance Scale for Children (TASC): Caregiver-Therapist
timeFrame: P1 (after first session), P2 (2 weeks), P3 (4 weeks), P4/T2 (6-9 weeks)
measure: Therapy Satisfaction: 3 questions
timeFrame: T3 (12-15 weeks) or before if treatment ends early.
measure: Therapeutic Alliance Scale for Children (TASC): Caregiver-Child
timeFrame: P2 (2 weeks), P3 (4 weeks), P4/T2 (6-9 weeks)
measure: Therapeutic Alliance Scale for Children (TASC): Child-Caregiver
timeFrame: P2 (2 weeks), P3 (4 weeks), P4/T2 (6-9 weeks)
measure: KIDSCREEN School environment module
timeFrame: T1 (start-up), T2 (6-9 weeks), T3 (12-15 weeks), 24-27 weeks (T4)
measure: Children's somatic symptoms inventory short form (CSSI-8)
timeFrame: T1 (start-up), T2 (6-9 weeks), T3 (12-15 weeks), 24-27 weeks (T4)
measure: Barriers for treatment
timeFrame: T1 (start-up)
measure: Leadership Implementation Scale (ILS)
timeFrame: Baseline (T0)
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian Center for Violence and Traumatic Stress Studies
Study officials:
affiliation: Norwegian Center for Violence and Traumatic Stress Studies
name: Ingeborg Skjærvø, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salloum A, Scheeringa MS, Cohen JA, Storch EA. Development of Stepped Care Trauma-Focused Cognitive-Behavioral Therapy for Young Children. Cogn Behav Pract. 2014 Feb 1;21(1):97-108. doi: 10.1016/j.cbpra.2013.07.004.