Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial of Emotion-Focused Skills Training for Parents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03807336
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Collaborators:
University of Oslo
The Research Council of Norway
University of Bergen
Information provided by (Responsible Party):
Institutt for Psykologisk Radgivning

Brief 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 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.

Condition or disease Intervention/treatment Phase
F01.318 Child Rearing F01.470 Emotions F01.145.179 Child Behavior Behavioral: Emotion-Focused Skills Training for Parents - Experiential Behavioral: Emotion-Focused Skills Training for Parents - Psychoeducational Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Clinical Trial
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : March 29, 2019
Estimated Study Completion Date : January 31, 2020

Arm Intervention/treatment
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.
Behavioral: Emotion-Focused Skills Training for Parents - Experiential
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.

Behavioral: Emotion-Focused Skills Training for Parents - Psychoeducational
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.

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.
Behavioral: Emotion-Focused Skills Training for Parents - Experiential
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.

Behavioral: Emotion-Focused Skills Training for Parents - Psychoeducational
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.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Secondary Outcome Measures :
  1. Outcome Questionnaire 45, Version 2, for the parents [ Time Frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up ]
    Outcome questionnaire designed to evaluate a psychotherapy client's progress initially and throughout treatment.

  2. 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 ]
  3. 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 ]

Other Outcome Measures:
  1. 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 ]
  2. Parents Sense of Competence Scale Full scale [ Time Frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up ]
  3. 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 ]
  4. Affect Integration Inventory Full scale: global affect integration [ Time Frame: Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807336


Contacts
Layout table for location contacts
Contact: Jan R Stiegler, PhD +4792211019 jan.stiegler@gmail.com
Contact: Nadia Ansar, Cand Psychol +4793061435 ansar@ipr.no

Locations
Layout table for location information
Norway
Institutt for Psykologisk rådgivning Recruiting
Bergen, Norway, 5012
Contact: Jan R Stiegler, PhD    +4792211019    stiegler@ipr.no   
Contact: Nadia Ansar, Cand Psychol    +4793061435    ansar@ipr.no   
Sponsors and Collaborators
Institutt for Psykologisk Radgivning
University of Oslo
The Research Council of Norway
University of Bergen

Layout table for additonal information
Responsible Party: Institutt for Psykologisk Radgivning
ClinicalTrials.gov Identifier: NCT03807336     History of Changes
Other Study ID Numbers: Nadia_RCT_2018
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No