F01.145.179 Child Behavior Clinical Trial
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
| Verified date | August 2022 |
| Source | Institutt for Psykologisk Radgivning |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 220 |
| Est. completion date | January 30, 2021 |
| Est. primary completion date | July 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years to 13 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Norway | Institutt for Psykologisk rådgivning | Bergen |
| Lead Sponsor | Collaborator |
|---|---|
| Institutt for Psykologisk Radgivning | The Research Council of Norway, University of Bergen, University of Oslo |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Parents Beliefs About Children's Emotions questionnaire Full scale | Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up | ||
| Other | Parents Sense of Competence Scale Full scale | Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up | ||
| Other | Coping with Children's Negative Emotion Scale Full scale | Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up | ||
| Other | Affect Integration Inventory Full scale: global affect integration | Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up | ||
| Primary | 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 | ||
| Primary | 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 | ||
| Primary | 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 | Outcome Questionnaire 45, Version 2, for the parents | Outcome questionnaire designed to evaluate a psychotherapy client's progress initially and throughout treatment. | Pre, post (0 months after completed intervention), 3, 6 and 9 months follow up | |
| Secondary | 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 | ||
| Secondary | 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 |