The Norwegian Stepped-Care TF-CBT Study

NCT04073862 | Completed

• 1 other identifier: SC-TF-CBT-pilot
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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. 1.How does the SC-TF-CBT model fit the Norwegian health care culture and service system?
2. 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. 3.Do the children, parents, and therapists like working with the method?
4. 4.Do recipients of the treatment (children and parents) report symptom improvement?
5. 5.Which children and parents seem to benefit the most from the method, and who do not?

Conditions

Post Traumatic Stress Disorder (PTSD); Depressive Symptoms; Parental Stress; Health Related Quality of Life

Keywords

Stepped-Care Trauma-Focused Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• CATS 2.0 (Children version / Caregiver version) - Assessment of Change in Symptoms

  Clinical Assessment of Trauma Paths and Symptoms (CATS) (Sachser et al., 2017). The investigators use a revised edition of CATS, based on DSM5 and ICD-11. CATS consists of 15 questions about stressful or scary experiences, 20 questions measuring level of post-traumatic stress responses (to be answered if "yes" on one of the first 15 items), and 5 questions about the social/ performance consequences of experienced problems. Both the Children's version and the Caregiver version of CATS 2.0 contain the same questions, but formulated according to their different points of view. The 15 questions about trauma events are answered by indicating "yes" or "no." The 20 items about symptomatology are scored from 0 (never) to 3 (almost all the time). The final 5 items are indicated with "yes" or "no." In order to measure change, the questions will be completed at three points in time by caregivers and children, respectively.

  Baseline (T0), 6-9 weeks (T2), 12-15 weeks (T3), 24-27 weeks (T4)

Secondary Outcomes (26)

• Quality of life in pre-adolescence: a 17-dimensional health-related measure (17D)

  T1 (start-up), 6-9 weeks (T2), T3 (12-15 weeks), 24-27 weeks (T4)

• Acceptability of Intervention Measure (AIM)

  Baseline (T0)

• Intervention Appropriateness Measure (IAM)

  Baseline (T0)

• Feasibility of Intervention Measure (FIM)

  Baseline (T0)

• Child and Adolescent Social Support Scale (CASSS 2000)

  T1 (start-up), T2 (6-9 weeks), T3 (12-15 weeks), 24-27 weeks (T4)

Study Arms (1)

Stepped-Care TF-CBT

OTHER

The study participants will receive Stepped-Care Trauma-Focused Cognitive-Behavioral-Therapy (SC-TF-CBT).

Other: Stepped-Care TF-CBT

Interventions

Stepped-Care TF-CBT OTHER

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.

Stepped-Care TF-CBT

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 7-12
• Exposure to at least one episode of violence or other potentially traumatizing event
• At least 3 years old at time of trauma
• 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

You may not qualify if:

• At least one month has passed since the last traumatic event.
• In addition:
• 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.
• Not fluent in Norwegian and needs interpreter to complete treatment
• The caregiver who would be treatment participant was the perpetrator, or perpetrator still living at home
• Parent has had substance use disorder (SUD) within the past 3 months.
• Child or caregiver is suicidal
• 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.
• Child is currently receiving an other type of trauma treatment

Sponsors & Collaborators

• Norwegian Center for Violence and Traumatic Stress Studies: lead
• University of South Florida: collaborator

Study Sites (1)

Norwegian Center for Violence and Traumatic Stress Studies

Oslo, 0484, Norway

Location

Related Publications (5)

• 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.

  PMID: 25411544 BACKGROUND

• Ormhaug SM, Skjaervo I, Dyrdal GM, Fagermoen EM, Haabrekke KJ, Jensen TK, Knutsen ML, Naess A, Paivarinne HM, Martinsen M. Stepping Together for Children After Trauma (ST-CT): Feasibility and Predictors of Outcome of a Parent-led, Therapist Assisted Treatment. Res Child Adolesc Psychopathol. 2024 Sep;52(9):1413-1425. doi: 10.1007/s10802-024-01199-5. Epub 2024 May 13.

  PMID: 38739305 DERIVED

• Fagermoen EM, Skjaervo I, Birkeland MS, Jensen TK, Ormhaug SM. The bidirectional associations between caregiver and child symptoms in the parent-led treatment stepping together for children after trauma. Behav Res Ther. 2024 Feb;173:104459. doi: 10.1016/j.brat.2023.104459. Epub 2023 Dec 16.

  PMID: 38128401 DERIVED

• Fagermoen EM, Skjaervo I, Jensen TK, Ormhaug SM. Parent-led stepped care for traumatised children: parental factors that predict treatment completion and response. Eur J Psychotraumatol. 2023;14(2):2225151. doi: 10.1080/20008066.2023.2225151.

  PMID: 37366166 DERIVED

• Fagermoen EM, Jensen TK, Martinsen M, Ormhaug SM. Parent-Led Stepped Care Trauma Treatment: Parents' Experiences With Helping Their Child Recover. J Child Adolesc Trauma. 2023 Mar 31;16(4):1-13. doi: 10.1007/s40653-023-00537-x. Online ahead of print.

  PMID: 37359465 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Ingeborg Skjærvø, PhD

  Norwegian Center for Violence and Traumatic Stress Studies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: August 29, 2019
• Study Start: May 13, 2019
• Primary Completion: March 15, 2022
• Study Completion: August 31, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)