- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03578016
COS-P for Parents of Children Referred to Child Psychiatric Services (COS-P)
A Randomized and Controlled Trial Using Circle of Security-Parenting for Parents of Children Referred to Child Psychiatric Services.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aida Bikic, PhD
- Phone Number: + 45 99 44 62 00
- Email: aida.bikic@rsyd.dk
Study Contact Backup
- Name: Søren Dalsgaard, PhD
- Email: sdalsgaard@econ.au.dk
Study Locations
-
-
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Aabenraa, Denmark, 6200
- Recruiting
- Department of Child and Adolescent Mental Health Services
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Circle of Security-Parenting
10 weekly, manualized group sessions at the clinic
|
COS-P is a brief, behavioral and insight oriented therapeutic group approach for parents with the aim to promote parental sensitivity and attachment and autonomy in the parent-child relationship.
The parents will participate in ten weekly 1,5-hour sessions at the clinic conducted by two COS-certified therapists.
Groups will include 4-5 families at a time.
Other Names:
TAU consists of clinical assessment and treatment.
Other Names:
|
Other: Treatment as Usual (TAU)
TAU consists of clinical assessment and treatment.
|
TAU consists of clinical assessment and treatment.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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after 10 weeks of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal Intrusiveness
Time Frame: after 10 weeks of intervention
|
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
|
after 10 weeks of intervention
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Maternal Sensitivity
Time Frame: 24 week follow-up
|
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
|
24 week follow-up
|
Maternal Intrusiveness
Time Frame: 24 week follow-up
|
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
|
24 week follow-up
|
Dyadic reciprocity
Time Frame: after 10 weeks of intervention
|
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
|
after 10 weeks of intervention
|
Dyadic reciprocity
Time Frame: 24 week follow-up
|
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
|
24 week follow-up
|
Negative states
Time Frame: after 10 weeks of intervention
|
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
|
after 10 weeks of intervention
|
Negative states
Time Frame: 24 week follow-up
|
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
|
24 week follow-up
|
Child Behaviour Check List (CBCL)-Total score-parent rated
Time Frame: after 10 weeks of intervention
|
Parent questionnaire on child symptoms.
Score range (0-236).
Higher indicates more problems.
|
after 10 weeks of intervention
|
Child Behaviour Check List (CBCL)-Total score-parent rated
Time Frame: 24 week follow-up
|
Parent questionnaire on child symptoms.
Score range: 0-236.
Higher indicates more problems.
|
24 week follow-up
|
CBCL-ODD score-parent rated. Score range: 0-26. Higher indicates more problems.
Time Frame: after 10 weeks of intervention
|
Parent questionnaire on child symptoms
|
after 10 weeks of intervention
|
CBCL-ODD score-parent rated. Score range: 0-26. Higher indicates more problems.
Time Frame: 24 week follow-up
|
Parent questionnaire on child symptoms
|
24 week follow-up
|
Berkeley Puppet interview
Time Frame: after 10 weeks of intervention
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Child interview
|
after 10 weeks of intervention
|
Berkeley Puppet interview
Time Frame: 24 week follow-up
|
Child interview
|
24 week follow-up
|
Coping with childrens negative emotions scale
Time Frame: baseline
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Parent questionnaire on their strategies coping with children's negative emotions.
Score range 72-504.
|
baseline
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Coping with childrens negative emotions scale
Time Frame: after 10 weeks of intervention
|
Parent questionnaire on their strategies coping with children's negative emotions.
Score range 72-504.
|
after 10 weeks of intervention
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Coping with childrens negative emotions scale
Time Frame: 24 week follow-up
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Parent questionnaire on their strategies coping with children's negative emotions.
Score range 72-504.
|
24 week follow-up
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Parental Reflective Functioning Questionnaire
Time Frame: baseline
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Parent self-report measure that assesses parental reflective functioning or mentalizing.
Score range 1-126.
|
baseline
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Parental Reflective Functioning Questionnaire
Time Frame: after 10 weeks of intervention
|
Parent self-report measure that assesses parental reflective functioning or mentalizing.
Score range 1-126.
|
after 10 weeks of intervention
|
Parental Reflective Functioning Questionnaire
Time Frame: 24 week follow-up
|
Parent self-report measure that assesses parental reflective functioning or mentalizing.
Score range 1-126.
|
24 week follow-up
|
Eyberg Child Behaviour Inventory (ECBI)
Time Frame: after 10 weeks of intervention
|
Parent questionnaire on child behavior.
Score range 36-252.
Higher indicating more problems.
|
after 10 weeks of intervention
|
Eyberg Child Behaviour Inventory (ECBI)
Time Frame: 24 week follow-up
|
Parent questionnaire on child behavior.
Score range 36-252.
Higher indicating more problems.
|
24 week follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major Depression Inventory- mother and partner
Time Frame: baseline
|
Parent questionnaire on their own depressive symptoms.
Score range 0-50.
Higher scores indicating more severe symptoms.
|
baseline
|
Revised Adult Attachment Scale (RAAS)
Time Frame: baseline
|
Questionnaire regarding the attachment style of the mother and partner.
Scofre range 18-90.
|
baseline
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Standardized Assessment of Personality (SAPAS)-mother and partner
Time Frame: baseline
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A short and simple interview-administered screen for personality disorders.
Score range 1-8, higher score indicating more problems.
|
baseline
|
Strength and Difficulties Questionnaire (SDQ)
Time Frame: baseline
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Parent questionnaire on the strength and difficulties of the child.
Total difficulties score 0-40.
Higher indicating more problems.
|
baseline
|
Strength and Difficulties Questionnaire (SDQ)
Time Frame: after 10 weeks of intervention
|
Parent questionnaire on the strength and difficulties of the child.
Total difficulties score 0-40.
Higher indicating more problems.
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after 10 weeks of intervention
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Strength and Difficulties Questionnaire (SDQ)
Time Frame: 24 week follow-up
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Parent questionnaire on the strength and difficulties of the child.
Total difficulties score 0-40.
Higher indicating more problems.
|
24 week follow-up
|
Brief Symptom Inventory
Time Frame: baseline
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Parent questionnaire on their own symptoms.
Score range 0-212.
Higher indicating more problems.
|
baseline
|
Attention Deficit Hyperactivity Disorder- Rating Scale (ADHD-RS)
Time Frame: after 10 weeks of intervention
|
Parent questionnaire on child ADHD symptoms.
Score range: 1-78.
Higher indicates more problems.
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after 10 weeks of intervention
|
Attention Deficit Hyperactivity Disorder- Rating Scale (ADHD-RS)
Time Frame: 24 weeks follow up
|
Parent questionnaire on child ADHD symptoms.
Score range: 1-78.
Higher indicates more problems.
|
24 weeks follow up
|
Parental Stress Scale
Time Frame: after 10 weeks of intervention
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Parent rating scale on their stress level.
Score range: 18-90.
Higher scores indicate more stress.
|
after 10 weeks of intervention
|
Parental Stress Scale
Time Frame: 24 week follow up
|
Parent rating scale on their stress level.
Score range: 18-90.
Higher scores indicate more stress.
|
24 week follow up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aida Bikic, PhD, University of Southern Denmark
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-58-0035 (Other Identifier: the Danish Data Protection Agency)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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