Mental Health IssueNCT04885036
Effectiveness of Emotion Focused Skills Training (EFST)
A study testing EFST intervention and Treatment As Usual in people with Mental Health Issue, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
Comparing the effectivity of an EFST parent supervision intervention against Treatment As Usual in an outpatient specialist health care clinics Family unit. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- EFST intervention and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteNorway
- Study dates
- 8 Dec 2021to 22 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An RCT Study Investigating the Effectiveness of Emotion Focused Skills Training (EFST)
Comparing the effectivity of an EFST parent supervision intervention against Treatment As Usual in an outpatient specialist health care clinics Family unit.
Read the 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.
- Conditions
- Mental Health Issue
- Being tested
- EFST intervention, Treatment As Usual
- Keywords
- Emotion focused skills training, Treatment outcome, Effectiveness, Mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFST interventionBehavioural
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.
Treatment As UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual | Active comparator | This group will receive treatment as usual within the family unit Receives: 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 Receives: Behavioral: EFST intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
To measure change in self-perceived quality of life, the Health-Related Quality of Life KINDL-R is used (Bullinger et al., 2008). KINDL-R will be filled out by parent and child.The KINDL-R questionnaire comprises 24 items to which the respondents are asked to respond on a 5-point Likert scale (never, seldom, sometimes, often, all the time). The resulting subscales are physical well-being, emotional well-being, self-esteem, family, friends, and everyday functioning (school or nursery school/kindergarten). The subscales of these six dimensions can be combined to produce a total score. Sum scale scores will be calculated by summing up the answer scores (1-5) of each scale. All scales will be transformed so that values range from 0 to 100, with higher values representing better quality of life.
Measured: T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0
Changes in parents emotional style
To measure Changes in parents emotional style the Emotion-Related Parenting Styles, ERPS (Paterson et al., 2012) will be used. ERPS is self-report measure for parents. ERPS consists of 20 items. Each item has to be scored on a 5-point scale fram "always false" to "always true". Scores on the items draws four subscales: Emotion Coaching parenting style (EC), Parental Rejection of negative emotion (PR), Parental acceptance of negative emotion (PA), Feeling of uncertainty /ineffectiveness in emotion socialization (UI). Higher scores indicates a better outcome on sbscales: EC and PA. Lower scores indicates better outcome on subscales PR and UI.
Measured: T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0
Changes in parents emotion regulation
To measure Changes in parents emotion regulation the Difficulties in Emotion Regulation Scale, short-form, DERS-18 (Victor, S. E., \& Klonsky, E. D. (2016) will be used. DERS is self-report measure for parents.The DERS-18 is comprised of three items per subscale, for six subscales (Awareness, Clarity, Goals, Impulse, Nonacceptance and Strategies), a total of 18 items. These include three reverse- coded items, all on the Awareness subscale. A total score can also be calculated. Lower scores indicates better outcome.
Measured: T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0
Change in parents symptoms mental distress
To measure mental health, and change in mental health in parents, the Hopkins Symptom Checklist-10 (HSCL-10) will be used. HSCL-10 is a self report form filled out by parents. It contains 10 items on a 4 point scale from 0=" Not at all" to 4="Very much". Higher scores indicates higher level of distress.HSCL-10 is a short form of the HSCL 25. A comparison study by Strand et al. showed that the shorter version of SCL performed almost as well as the full version. (Strand et al. 2003)
Measured: T0 = At randomization, T1 = 3 months after
Change in the quality of parents relationship with child
To measure parents relationship with child, and changes in relationship with the child, "the relationship with child RWC" (Pinsof, 2017) will be used. RWC is a self report filled out by parents. It contains 6 items on a 5 point scale from "never" to "all the time". Higher scores indicates a better perceived relationship with the child.
Measured: T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start8 Dec 2021
- Primary completion24 Apr 2024
- Study completion22 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- South-Eastern Norway Regional Health Authority
- Responsible party
- Sponsor
- Investigators
- Rune H Zahl-Olsen, Ph.D, Principal investigator, Senior researcher at Sørlandet Hospital HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885036
- Sponsor's protocol ID
- SorlandetHF Zahl-Olsen
- Status last verified
- May 2025
- First submitted
- 24 Mar 2021
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data stems from a clinical population of vulnerable families
Publications
Severinsen L, Stiegler JR, Nissen-Lie HA, Shahar B, Zahl-Olsen R. The Difficulties in Emotion Regulation Scale Short Form: A Confirmatory Factor Analysis Among Parents of Children With Mental Health Disorders in Norway. Scand J Psychol. 2026 Aug;67(4):1157-1166. doi: 10.1111/sjop.70095. Epub 2026 Apr 3.
PubMed 41933936Severinsen 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.
PubMed 35799120
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An RCT Study Investigating the Effectiveness of Emotion Focused Skills Training (EFST)
- ClinicalTrials.gov ID
- NCT04885036
- Acronym / sponsor ID
- SorlandetHF Zahl-Olsen
- Conditions
- Mental Health Issue
- Keywords
- Emotion focused skills training, Treatment outcome, Effectiveness, Mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- South-Eastern Norway Regional Health Authority
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 22 Dec 2024 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual | Active comparator | Behavioral: Treatment As UsualThis group will receive treatment as usual within the family unit |
| EFST intervention | Experimental | Behavioral: EFST interventionThis group will receive an EFST stand alone treatment consisting of a two days EFST course and 6 individual parental guidance sessions |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EFST interventionEFST 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. | Behavioural | EFST intervention |
| Treatment As UsualIn 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. | Behavioural | Treatment As Usual |
Primary outcome
Change in childrens symptoms and diagnosis
Time frame: T0=At randomization, T1= 3 months after T0
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.
Change in reported symptoms and distress
Time frame: T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0
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.
5 secondary outcomes
Change in reported Health-Related Quality of Life
Time frame: T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0
Changes in parents emotional style
Time frame: T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0
Changes in parents emotion regulation
Time frame: T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0
Change in parents symptoms mental distress
Time frame: T0 = At randomization, T1 = 3 months after
Change in the quality of parents relationship with child
Time frame: T0 = At randomization, T1 = 3 months after T0, T2 = 6 months after T0, T3 = 12 months after T0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Derived from this study: PubMed 41933936Severinsen L, Stiegler JR, Nissen-Lie HA, Shahar B, Zahl-Olsen R. The Difficulties in Emotion Regulation Scale Short Form: A Confirmatory Factor Analysis Among Parents of Children With Mental Health Disorders in Norway. Scand J Psychol. 2026 Aug;67(4):1157-1166. doi: 10.1111/sjop.70095. Epub 2026 Apr 3.
- Derived from this study: PubMed 35799120Severinsen 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.
- Individual participant dataSharing planned: No. The data stems from a clinical population of vulnerable families
Related trials for Mental Health Issue
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Active, not recruiting
Digital Therapeutics for Behavior Problems
Problem Behavior, Child Behavior
Recruiting
VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
Lewy Bodies Disease, Depression Disorder
Active, not recruiting
Tailoring CPP for the Foster Care Setting
Behavior Problem
Active, not recruiting
Supporting Health in Veterans With Heart Failure
Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rune H Zahl-Olsen, Ph.D principal investigator
Senior researcher at Sørlandet Hospital HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EFST intervention and Treatment As Usual in people with Mental Health Issue, run by Sorlandet Hospital HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in childrens symptoms and diagnosis (time frame: T0=At randomization, T1= 3 months after T0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04885036, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.