Clinical trial NCT03578016: COS-P for Parents of Children Referred to Child Psychiatric Services
Official title: A Randomized and Controlled Trial Using Circle of Security-Parenting for Parents of Children Referred to Child Psychiatric Services.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Behavior Problem
Keywords: attachment
parent
training
sensitivity
Lead sponsor: Region Syddanmark
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 128
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background:The quality of attachment is greatly influenced by parental sensitivity. Attachment based interventions are designed to promote parental sensitivity, to change parental mental representations and to improve understanding of the developmental needs of the child. Very few studies have investigated the effect of attachment-based interventions on psychiatric symptoms in children. Targeting parental sensitivity and the parent-child interaction might have an important impact on psychiatric symptoms in a clinical sample of children referred to child psychiatric services.

Objectives: The primary objective is to investigate whether Circle of Security-Parenting (COS-P) has an effect on parental sensitivity in parents of children referred to child psychiatric services. The secondary objectives are to investigate the effect on children's behavioral and emotional symptoms and the parental stress and reflective functioning after 10 weeks of intervention and at the 24 week follow-up. The study is also exploring the effect of parental attachment style, parental stress and parental psychopathology on the effect of the intervention.

Methods: The trial will include 128 families of children (age 3-8 years) who are referred to child psychiatric services in a randomized and controlled design. Included families will be randomized to COS-P+ Treatment as Usual (TAU) or TAU only.

Perspectives: Considering the important impact of the quality of the parent-child relationship on the child's well-being, it is essential to target it in interventions and to investigate the relation with psychiatric symptoms. Generally there is a lack of interventions targeting parental sensitivity in psychiatric child populations. Working with the parents on the child-parent relation, might have an important impact on their children's current psychiatric symptoms and could additionally prevent future psychopathology.


Eligibility criteria: Inclusion Criteria:

* Children who score equal or above the 93d percentile on CBCL-total score
* Score above 93d percentile on the CBCL- ODD or aggression scale
* Informed consent from both custody.

Exclusion Criteria:

For children:

* autism spectrum disorders
* serious psychopathology requiring immediate clinical attention
* head injury or verified neurological disease
* intelligence quotient (IQ) \<80
* medical condition, requiring treatment
* no informed consent from custody

For parents:

* a diagnosis of schizophrenia
* bipolar disorder
* known substance abuse
* severe intellectual impairment
* suicide attempt in the past

Primary outcomes:
measure: Maternal sensitivity
timeFrame: after 10 weeks of intervention
Secondary outcomes:
measure: Maternal Intrusiveness
timeFrame: after 10 weeks of intervention
measure: Maternal Sensitivity
timeFrame: 24 week follow-up
measure: Maternal Intrusiveness
timeFrame: 24 week follow-up
measure: Dyadic reciprocity
timeFrame: after 10 weeks of intervention
measure: Dyadic reciprocity
timeFrame: 24 week follow-up
measure: Negative states
timeFrame: after 10 weeks of intervention
measure: Negative states
timeFrame: 24 week follow-up
measure: Child Behaviour Check List (CBCL)-Total score-parent rated
timeFrame: after 10 weeks of intervention
measure: Child Behaviour Check List (CBCL)-Total score-parent rated
timeFrame: 24 week follow-up
measure: CBCL-ODD score-parent rated. Score range: 0-26. Higher indicates more problems.
timeFrame: after 10 weeks of intervention
measure: CBCL-ODD score-parent rated. Score range: 0-26. Higher indicates more problems.
timeFrame: 24 week follow-up
measure: Berkeley Puppet interview
timeFrame: after 10 weeks of intervention
measure: Berkeley Puppet interview
timeFrame: 24 week follow-up
measure: Coping with childrens negative emotions scale
timeFrame: baseline
measure: Coping with childrens negative emotions scale
timeFrame: after 10 weeks of intervention
measure: Coping with childrens negative emotions scale
timeFrame: 24 week follow-up
measure: Parental Reflective Functioning Questionnaire
timeFrame: baseline
measure: Parental Reflective Functioning Questionnaire
timeFrame: after 10 weeks of intervention
measure: Parental Reflective Functioning Questionnaire
timeFrame: 24 week follow-up
measure: Eyberg Child Behaviour Inventory (ECBI)
timeFrame: after 10 weeks of intervention
measure: Eyberg Child Behaviour Inventory (ECBI)
timeFrame: 24 week follow-up
Other outcomes:
measure: Major Depression Inventory- mother and partner
timeFrame: baseline
measure: Revised Adult Attachment Scale (RAAS)
timeFrame: baseline
measure: Standardized Assessment of Personality (SAPAS)-mother and partner
timeFrame: baseline
measure: Strength and Difficulties Questionnaire (SDQ)
timeFrame: baseline
measure: Strength and Difficulties Questionnaire (SDQ)
timeFrame: after 10 weeks of intervention
measure: Strength and Difficulties Questionnaire (SDQ)
timeFrame: 24 week follow-up
measure: Brief Symptom Inventory
timeFrame: baseline
measure: Attention Deficit Hyperactivity Disorder- Rating Scale (ADHD-RS)
timeFrame: after 10 weeks of intervention
measure: Attention Deficit Hyperactivity Disorder- Rating Scale (ADHD-RS)
timeFrame: 24 weeks follow up
measure: Parental Stress Scale
timeFrame: after 10 weeks of intervention
measure: Parental Stress Scale
timeFrame: 24 week follow up
Locations:
city: Aabenraa
country: Denmark
facility: Department of Child and Adolescent Mental Health Services
Study officials:
affiliation: University of Southern Denmark
name: Aida Bikic, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bikic A, Smith-Nielsen J, Dalsgaard S, Swain J, Fonagy P, Leckman JF. Protocol for a randomized controlled trial comparing the Circle of Security-parenting (COS-P) with treatment as usual in child mental health services. PLoS One. 2022 Apr 26;17(4):e0265676. doi: 10.1371/journal.pone.0265676. eCollection 2022.