NCT03807336

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

1.8 years

First QC Date

January 14, 2019

Last Update Submit

August 2, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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

    Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up

  • Difficulties in Emotion Regulation Scale

    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.

    Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up

Other Outcomes (4)

  • Parents Beliefs About Children's Emotions questionnaire Full scale

    Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up

  • Parents Sense of Competence Scale Full scale

    Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up

  • Coping with Children's Negative Emotion Scale Full scale

    Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up

  • +1 more other outcomes

Study Arms (2)

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.

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

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

Interventions

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.

Experiential ConditionPsychoeducational version

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.

Experiential ConditionPsychoeducational version

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institutt for Psykologisk rådgivning

Bergen, 5012, Norway

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2019

First Posted

January 16, 2019

Study Start

October 1, 2018

Primary Completion

July 30, 2020

Study Completion

January 30, 2021

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations