F01.318 Child RearingNCT03807336
Clinical Trial of Emotion-Focused Skills Training for Parents
A study testing Emotion-Focused Skills Training for Parents - Experiential and Emotion-Focused Skills Training for Parents - Psychoeducational in people with F01.318 Child Rearing and F01.470 Emotions, run by Institutt for Psykologisk Radgivning at 1 site in Norway.
Trial summary
Children with externalizing and internalizing symptoms has been linked to poor emotional competence, problematic understanding and regulation of emotions. A number of recent studies demonstrates the importance of parents' active involvement in the child's recovery process and support the empirical relationship between… Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- F01.318 Child Rearing, F01.470 Emotions, F01.145.179 Child Behavior
- What is being tested?
- Emotion-Focused Skills Training for Parents - Experiential and Emotion-Focused Skills Training for Parents - Psychoeducational
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2018to 30 Jan 2021
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents of children between 6-13 with either internalizing problems, externalizing problems, or both.
- An overall final assessment of whether it is likely that the parents will be able to fully participate in the study.
- Parents who live with the child at least 50% of the time.
- Parents who agree that they need help and are motivated for the treatment.
- Parents and children who speak Norwegian
- Parents who have the time to participate in the intervention program.
- Parents who are willing to collaborate with the childs school and contact with the school teacher.
Who cannot join
- Parents: Serious or chronic mental health difficulties such as psychosis, bipolar disorder, organic disorder, ongoing substance abuse, do.
- documented sexual abuse, serious mental health problems, organic disorder and/or disability in the child.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Outcome for Children Through Treatment of Their Parents - Comparing Emotion-Focused Parent Skills Training With Emotion Coaching Parent Program for Children With Externalizing and Internalizing Symptoms: a Randomized Controlled Trial
Children with externalizing and internalizing symptoms has been linked to poor emotional competence, problematic understanding and regulation of emotions. A number of recent studies demonstrates the importance of parents' active involvement in the child's recovery process and support the empirical relationship between parenting style and child symptoms. Emotional awareness and acceptance of painful emotional experience in parents leads to reduction in how these emotions are experienced in response to stressors in children. This makes the parent less vulnerable to rumination or suppression of negative emotional experience related to the child. In addition, it releases parents' emotional capacity to be mentally present and emotionally available for their child. Although neuro-affective principles from research have been incorporated in the therapeutic approaches for adults, there are currently no programs that target these mechanisms in working with children with mental health difficulties. Emotion Focused Skills Training (EFST) is an easily administrated, cost efficient treatment program specifically directed towards the parental role in promoting change in children. In this randomized controlled trial, we will compare experiential process oriented EFST with a psycho-educational version of EFST on parents of children aged 6-13 with externalizing or internalizing symptoms. Parents of 236 children will receive a two days course and 6 hours of individually delivered treatment within a 10 weeks period, either with the experiential version of EFST or the psycho-educational version. Feedback regarding outcome on externalizing and internalizing problems will be obtained from parents and teachers at 5 different periods: baseline, treatment completion and at 3, 6 and 9 months follow-up.
- Being tested
- Emotion-Focused Skills Training for Parents - Experiential, Emotion-Focused Skills Training for Parents - Psychoeducational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion-Focused Skills Training for Parents - ExperientialBehavioural
The intervention consists of a 2-day work shop given in a group format, in addition to 6 hours of parent supervision within 6 weeks after the work shop.
Emotion-Focused Skills Training for Parents - PsychoeducationalBehavioural
The intervention consists of a 2-day work shop given in a group format, in addition to 6 hours of parent supervision within 6 weeks after the work shop.
| Study group | Role | What they receive |
|---|---|---|
| Experiential Condition | Experimental | This group will receive an experiential version of the program Emotion-Focused Skills Training for Parents, meaning they will engage in tasks that are supposed to activate the parents emotional system, providing them with a deeper sense of understanding towards their child. Receives: Behavioral: Emotion-Focused Skills Training for Parents - Experiential; Behavioral: Emotion-Focused Skills Training for Parents - Psychoeducational |
| Psychoeducational version | Active comparator | This group will receive a non-experiential, psychoeducational version of the program Emotion-Focused Skills Training for Parents, meaning they will not engage in tasks that are meant to activate the parents emotional system. Receives: Behavioral: Emotion-Focused Skills Training for Parents - Experiential; Behavioral: Emotion-Focused Skills Training for Parents - Psychoeducational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SDQ-P 4-17 - Strengths and Difficulties Questionnaire and impact supplement for the parents of 4-17 year olds All 5 subscales and total score will be used.
Measured: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
Change in ASEBA Child Behavior Checklist for Ages 6-18 All eight subscales and total scores will be used.
Measured: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
Change in ASEBA - Child Behavior Checklist - Teacher Report Form All eight subscales and total scores will be used.
Measured: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
Secondary outcomes (3)
Outcome Questionnaire 45, Version 2, for the parents
Outcome questionnaire designed to evaluate a psychotherapy client's progress initially and throughout treatment.
Measured: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
Difficulties in Emotion Regulation Scale
Measured: Pre, post, 3 months, 6 months, 9 monthsPre, post (0 months after completed intervention), 3, 6 and 9 months follow up
Forms of Self-Criticising/Attacking & Self-Reassuring Scale All 3 subscales will be used: Inadequate self, Hated self, Reassured self.
Measured: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start1 Oct 2018
- Primary completion30 Jul 2020
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for F01.318 Child RearingStudies 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
- Randomized Clinical Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institutt for Psykologisk Radgivning
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, The Research Council of Norway, University of Bergen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807336
- Sponsor's protocol ID
- Nadia_RCT_2018
- Status last verified
- Aug 2022
- First submitted
- 14 Jan 2019
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ansar N, Nissen Lie HA, Stiegler JR. The effects of emotion-focused skills training on parental mental health, emotion regulation and self-efficacy: Mediating processes between parents and children. Psychother Res. 2024 Apr;34(4):518-537. doi: 10.1080/10503307.2023.2218539. Epub 2023 Jun 13.
PubMed 37311111
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcome for Children Through Treatment of Their Parents - Comparing Emotion-Focused Parent Skills Training With Emotion Coaching Parent Program for Children With Externalizing and Internalizing Symptoms: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03807336
- Acronym / sponsor ID
- Nadia_RCT_2018
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Institutt for Psykologisk RadgivningUniversity, hospital or other
- Collaborators
- University of Oslo, The Research Council of Norway, University of Bergen
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 16 Jan 2019 (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.
Children with externalizing and internalizing symptoms has been linked to poor emotional competence, problematic understanding and regulation of emotions. A number of recent studies demonstrates the importance of parents' active involvement in the child's recovery process and support the empirical relationship between parenting style and child symptoms. Emotional awareness and acceptance of painful emotional experience in parents leads to reduction in how these emotions are experienced in response to stressors in children. This makes the parent less vulnerable to rumination or suppression of negative emotional experience related to the child. In addition, it releases parents' emotional capacity to be mentally present and emotionally available for their child. Although neuro-affective principles from research have been incorporated in the therapeutic approaches for adults, there are currently no programs that target these mechanisms in working with children with mental health difficulties. Emotion Focused Skills Training (EFST) is an easily administrated, cost efficient treatment program specifically directed towards the parental role in promoting change in children. In this randomized controlled trial, we will compare experiential process oriented EFST with a psycho-educational version of EFST on parents of children aged 6-13 with externalizing or internalizing symptoms. Parents of 236 children will receive a two days course and 6 hours of individually delivered treatment within a 10 weeks period, either with the experiential version of EFST or the psycho-educational version. Feedback regarding outcome on externalizing and internalizing problems will be obtained from parents and teachers at 5 different periods: baseline, treatment completion and at 3, 6 and 9 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Experiential Condition | Experimental | Behavioral: Emotion-Focused Skills Training for Parents - Experiential, Behavioral: Emotion-Focused Skills Training for Parents - PsychoeducationalThis group will receive an experiential version of the program Emotion-Focused Skills Training for Parents, meaning they will engage in tasks that are supposed to activate the parents emotional system, providing them with a deeper sense of understanding towards their child. |
| Psychoeducational version | Active comparator | Behavioral: Emotion-Focused Skills Training for Parents - Experiential, Behavioral: Emotion-Focused Skills Training for Parents - PsychoeducationalThis group will receive a non-experiential, psychoeducational version of the program Emotion-Focused Skills Training for Parents, meaning they will not engage in tasks that are meant to activate the parents emotional system. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Parents of children between 6-13 with either internalizing problems, externalizing problems, or both.
- An overall final assessment of whether it is likely that the parents will be able to fully participate in the study.
- Parents who live with the child at least 50% of the time.
- Parents who agree that they need help and are motivated for the treatment.
- Parents and children who speak Norwegian
Key exclusion criteria (2 listed)
- Parents: Serious or chronic mental health difficulties such as psychosis, bipolar disorder, organic disorder, ongoing substance abuse, do.
- documented sexual abuse, serious mental health problems, organic disorder and/or disability in the child.
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 |
|---|---|---|
| Emotion-Focused Skills Training for Parents - ExperientialThe intervention consists of a 2-day work shop given in a group format, in addition to 6 hours of parent supervision within 6 weeks after the work shop. | Behavioural | Experiential Condition, Psychoeducational version |
| Emotion-Focused Skills Training for Parents - PsychoeducationalThe intervention consists of a 2-day work shop given in a group format, in addition to 6 hours of parent supervision within 6 weeks after the work shop. | Behavioural | Experiential Condition, Psychoeducational version |
Primary outcome
Change in SDQ-P 4-17 - Strengths and Difficulties Questionnaire and impact supplement for the parents of 4-17 year olds All 5 subscales and total score will be used.
Time frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
Change in ASEBA Child Behavior Checklist for Ages 6-18 All eight subscales and total scores will be used.
Time frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
Change in ASEBA - Child Behavior Checklist - Teacher Report Form All eight subscales and total scores will be used.
Time frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
3 secondary outcomes
Outcome Questionnaire 45, Version 2, for the parents
Time frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
Difficulties in Emotion Regulation Scale
Time frame: Pre, post, 3 months, 6 months, 9 monthsPre, post (0 months after completed intervention), 3, 6 and 9 months follow up
Forms of Self-Criticising/Attacking & Self-Reassuring Scale All 3 subscales will be used: Inadequate self, Hated self, Reassured self.
Time frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
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 3 Aug 2022.
- Derived from this study: PubMed 37311111Ansar N, Nissen Lie HA, Stiegler JR. The effects of emotion-focused skills training on parental mental health, emotion regulation and self-efficacy: Mediating processes between parents and children. Psychother Res. 2024 Apr;34(4):518-537. doi: 10.1080/10503307.2023.2218539. Epub 2023 Jun 13.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion-Focused Skills Training for Parents - Experiential and Emotion-Focused Skills Training for Parents - Psychoeducational in people with F01.318 Child Rearing and F01.470 Emotions, run by Institutt for Psykologisk Radgivning 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 7 inclusion and 2 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 3 Aug 2022. 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 SDQ-P 4-17 - Strengths and Difficulties Questionnaire and impact supplement for the parents of 4-17 year olds All 5 subscales and total score will be used. (time frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up). The study lists 3 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 NCT03807336, which also lists 1 linked publication.
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 3 Aug 2022.