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Clinical Trials/NCT03578016
NCT03578016
Unknown
Not Applicable

A Randomized and Controlled Trial Using Circle of Security-Parenting for Parents of Children Referred to Child Psychiatric Services.

Region Syddanmark1 site in 1 country128 target enrollmentAugust 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Child Behavior Problem
Sponsor
Region Syddanmark
Enrollment
128
Locations
1
Primary Endpoint
Maternal sensitivity
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2018
End Date
December 30, 2023
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Region Syddanmark
Responsible Party
Principal Investigator
Principal Investigator

Aida Bikic

assistant professor, ph.d.

Region Syddanmark

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

Outcomes

Primary Outcomes

Maternal sensitivity

Time Frame: after 10 weeks of intervention

Maternal sensitivity is measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)

Secondary Outcomes

  • Berkeley Puppet interview(24 week follow-up)
  • Maternal Intrusiveness(24 week follow-up)
  • Maternal Sensitivity(24 week follow-up)
  • Dyadic reciprocity(24 week follow-up)
  • Negative states(24 week follow-up)
  • Child Behaviour Check List (CBCL)-Total score-parent rated(24 week follow-up)
  • CBCL-ODD score-parent rated. Score range: 0-26. Higher indicates more problems.(24 week follow-up)
  • Coping with childrens negative emotions scale(24 week follow-up)
  • Parental Reflective Functioning Questionnaire(24 week follow-up)
  • Eyberg Child Behaviour Inventory (ECBI)(24 week follow-up)

Study Sites (1)

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