Clinical trial NCT04885036: Effectiveness of Emotion Focused Skills Training (EFST)
Official title: An RCT Study Investigating the Effectiveness of Emotion Focused Skills Training (EFST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Keywords: Emotion focused skills training
Treatment outcome
Effectiveness
Mental health
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: South-Eastern Norway Regional Health Authority
First posted: 2021-05-13
Enrollment: 72
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Clinical Trial comparing Emotion-focused skills training (EFST) up against treatment as usual in an outpatient specialist mental health clinics family team.
Primary purpose: TREATMENT

Brief summary: Comparing the effectivity of an EFST parent supervision intervention against Treatment As Usual in an outpatient specialist health care clinics Family unit.

Detailed description: The aim of this study is to compare two different treatment conditions and their effect on the mental health of children and adolescent clients.

The first condition is the typical mental health treatment offered when the family is motivated to receive family based interventions in the clinic, thus, treatment as usual TAU as provided by the cliniques family team. A prior study, including data from the same clinic, found that the TAU was associated with good outcomes, identifying effect sizes equal to what is usual in clinical studies

The second condition, labelled: EFST intervention is a parent guidance intervention delivered as a two-day intensive group course followed by six weekly guidance sessions for parents of children with mental health issues.

Both treatment conditions are currently delivered at the clinic and by randomly assigning clients to each of these we will be able to compare the effects they have on the mental health of children and adolescents. The results will possibly guide what treatments to offer in the future.

Eligibility criteria: Inclusion Criteria:

* Children with a wide range of diagnosis will be included.
* Children in the age group from 6-18 years in the mental health clinic will be invited to participate.
* It is preferred that both parents participate in the EFST treatment.

Exclusion Criteria:

* parents need to live with the child at least 50% of the time (if separated or divorced)
* Parents need to speak Norwegian to a degree that they can comprehend the psychoeducation and participate in the sessions without an interpreter.
* parents with ongoing substance abuse or mental states that make participation too difficult, e.g., psychosis, will be excluded.

Primary outcomes:
measure: Change in childrens symptoms and diagnosis
timeFrame: T0=At randomization, T1= 3 months after T0
measure: Change in reported symptoms and distress
timeFrame: T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0
Secondary outcomes:
measure: Change in reported Health-Related Quality of Life
timeFrame: T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0
measure: Changes in parents emotional style
timeFrame: T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0
measure: Changes in parents emotion regulation
timeFrame: T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0
measure: Change in parents symptoms mental distress
timeFrame: T0 = At randomization, T1 = 3 months after
measure: Change in the quality of parents relationship with child
timeFrame: T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sørlandet Hospital HF
state: Agder
Study officials:
affiliation: Senior researcher at Sørlandet Hospital HF
name: Rune H Zahl-Olsen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Severinsen L, Stiegler JR, Nissen-Lie HA, Shahar B, Zahl-Olsen R. Effectiveness of emotion focused skills training for parents: study protocol for a randomized controlled trial in specialist mental health care. BMC Psychiatry. 2022 Jul 7;22(1):453. doi: 10.1186/s12888-022-04084-x.