- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03807336
Clinical Trial of Emotion-Focused Skills Training for Parents
August 2, 2022 updated by: Institutt for Psykologisk Radgivning
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
220
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bergen, Norway, 5012
- Institutt for Psykologisk rådgivning
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Experiential Condition
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.
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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.
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.
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Active Comparator: Psychoeducational version
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.
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
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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
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Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
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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
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Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Outcome Questionnaire 45, Version 2, for the parents
Time Frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
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Outcome questionnaire designed to evaluate a psychotherapy client's progress initially and throughout treatment.
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Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
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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
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Pre, post, 3 months, 6 months, 9 monthsPre, post (0 months after completed intervention), 3, 6 and 9 months follow up
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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
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Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Parents Beliefs About Children's Emotions questionnaire Full scale
Time Frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
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Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
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Parents Sense of Competence Scale Full scale
Time Frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
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Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
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Coping with Children's Negative Emotion Scale Full scale
Time Frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
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Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
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Affect Integration Inventory Full scale: global affect integration
Time Frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
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Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Actual)
July 30, 2020
Study Completion (Actual)
January 30, 2021
Study Registration Dates
First Submitted
January 14, 2019
First Submitted That Met QC Criteria
January 15, 2019
First Posted (Actual)
January 16, 2019
Study Record Updates
Last Update Posted (Actual)
August 3, 2022
Last Update Submitted That Met QC Criteria
August 2, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- Nadia_RCT_2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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