NCT04885036

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

December 8, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2024

Completed
Last Updated

June 5, 2025

Status Verified

May 1, 2025

Enrollment Period

2.4 years

First QC Date

March 24, 2021

Last Update Submit

June 2, 2025

Conditions

Keywords

Emotion focused skills trainingTreatment outcomeEffectivenessMental health

Outcome Measures

Primary Outcomes (2)

  • Change in childrens symptoms and diagnosis

    To establish and measure change in childrens symptoms and diagnosis of mental distress, our main outcome measure will be the semi-structured diagnostic interview Schedule for Affective Disorders and Schizophrenia, present and lifetime version (Kiddie-SADS-PL), DSM-IV version (Kaufman, 1997). the Kiddie-sads will be completed at randomization and then repeated after 3 months to investigate the presence of diagnosis. A diagnosis will be rated as present or not present, with the threshold for presence being defined as a score of at least 3 within each diagnosis.

    T0=At randomization, T1= 3 months after T0

  • Change in reported symptoms and distress

    To measure change in childrens symptoms of mental distress, the Strength and Difficulties Questionnaire, SDQ (Goodman et al., 2000) will be used. The child will be filling it out him/herself electronically (from 11 yeas of age), as well as the parents and teacher. The SDQ consists of 25 items describing positive and negative attributes of children and adolescents that can be allocated to 5 subscales. Each item has to be scored on a 3-point scale with 0 = 'not true', 1 = 'somewhat true', and 2 = 'certainly true'. A total difficulties score will also be calculated(range 0-40).Lower scores indicates better outcome.

    T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0

Secondary Outcomes (5)

  • Change in reported Health-Related Quality of Life

    T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0

  • Changes in parents emotional style

    T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0

  • Changes in parents emotion regulation

    T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0

  • Change in parents symptoms mental distress

    T0 = At randomization, T1 = 3 months after

  • Change in the quality of parents relationship with child

    T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0

Study Arms (2)

Treatment As Usual

ACTIVE COMPARATOR

This group will receive treatment as usual within the family unit

Behavioral: Treatment As Usual

EFST intervention

EXPERIMENTAL

This group will receive an EFST stand alone treatment consisting of a two days EFST course and 6 individual parental guidance sessions

Behavioral: EFST intervention

Interventions

EFST extended intervention is a stand-alone treatment that consist of a two days EFST group course followed by six weekly individual sessions of parental guidance by a licensed EFST therapist. The treatment is given indirectly to the child through work with the parent, thus it might remove or diminish the pressure on the children that suffer from mental health problems to solve their disorder themselves. In this condition a total of 19 hours of EFST treatment is provided.

EFST intervention

In the TAU condition, the families will receive treatment as usual that does not include EFST treatment. Recent research indicates that this is therapy of high quality carried out by highly qualified staff (Tilden et al., 2020; Zahl-Olsen et al., 2020).The therapists are educated psychologists, psychiatrist and family therapists. The TAU intends to be the best treatment for the child/ family based on the type of symptoms presented and requests from the patient and his/her family. We will measure the intensity and type of therapy given in this condition by information from the therapists and investigate that it did not include the main elements of EFST treatment.

Treatment As Usual

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sørlandet Hospital HF

Kristiansand, Agder, 4600, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Rune H Zahl-Olsen, Ph.D

    Senior researcher at Sørlandet Hospital HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A Randomized Clinical Trial comparing Emotion-focused skills training (EFST) up against treatment as usual in an outpatient specialist mental health clinics family team.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2021

First Posted

May 13, 2021

Study Start

December 8, 2021

Primary Completion

April 24, 2024

Study Completion

December 22, 2024

Last Updated

June 5, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

The data stems from a clinical population of vulnerable families

Locations