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COS-P for Parents of Children Referred to Child Psychiatric Services (COS-P)

Primary Purpose

Child Behavior Problem

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Circle of Security-Parenting
Treatment as Usual
Sponsored by
Region Syddanmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Child Behavior Problem focused on measuring attachment, parent, training, sensitivity

Eligibility Criteria

3 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Child and Adolescent Mental Health ServicesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Circle of Security-Parenting

Treatment as Usual (TAU)

Arm Description

10 weekly, manualized group sessions at the clinic

TAU consists of clinical assessment and treatment.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Maternal Intrusiveness
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Maternal Sensitivity
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Maternal Intrusiveness
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Dyadic reciprocity
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Dyadic reciprocity
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Negative states
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Negative states
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Child Behaviour Check List (CBCL)-Total score-parent rated
Parent questionnaire on child symptoms. Score range (0-236). Higher indicates more problems.
Child Behaviour Check List (CBCL)-Total score-parent rated
Parent questionnaire on child symptoms. Score range: 0-236. Higher indicates more problems.
CBCL-ODD score-parent rated. Score range: 0-26. Higher indicates more problems.
Parent questionnaire on child symptoms
CBCL-ODD score-parent rated. Score range: 0-26. Higher indicates more problems.
Parent questionnaire on child symptoms
Berkeley Puppet interview
Child interview
Berkeley Puppet interview
Child interview
Coping with childrens negative emotions scale
Parent questionnaire on their strategies coping with children's negative emotions. Score range 72-504.
Coping with childrens negative emotions scale
Parent questionnaire on their strategies coping with children's negative emotions. Score range 72-504.
Coping with childrens negative emotions scale
Parent questionnaire on their strategies coping with children's negative emotions. Score range 72-504.
Parental Reflective Functioning Questionnaire
Parent self-report measure that assesses parental reflective functioning or mentalizing. Score range 1-126.
Parental Reflective Functioning Questionnaire
Parent self-report measure that assesses parental reflective functioning or mentalizing. Score range 1-126.
Parental Reflective Functioning Questionnaire
Parent self-report measure that assesses parental reflective functioning or mentalizing. Score range 1-126.
Eyberg Child Behaviour Inventory (ECBI)
Parent questionnaire on child behavior. Score range 36-252. Higher indicating more problems.
Eyberg Child Behaviour Inventory (ECBI)
Parent questionnaire on child behavior. Score range 36-252. Higher indicating more problems.

Full Information

First Posted
April 8, 2018
Last Updated
July 13, 2020
Sponsor
Region Syddanmark
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1. Study Identification

Unique Protocol Identification Number
NCT03578016
Brief Title
COS-P for Parents of Children Referred to Child Psychiatric Services
Acronym
COS-P
Official Title
A Randomized and Controlled Trial Using Circle of Security-Parenting for Parents of Children Referred to Child Psychiatric Services.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Syddanmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Behavior Problem
Keywords
attachment, parent, training, sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Circle of Security-Parenting
Arm Type
Experimental
Arm Description
10 weekly, manualized group sessions at the clinic
Arm Title
Treatment as Usual (TAU)
Arm Type
Other
Arm Description
TAU consists of clinical assessment and treatment.
Intervention Type
Other
Intervention Name(s)
Circle of Security-Parenting
Other Intervention Name(s)
COS-P
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Other Intervention Name(s)
TAU
Intervention Description
TAU consists of clinical assessment and treatment.
Primary Outcome Measure Information:
Title
Maternal sensitivity
Description
Maternal sensitivity is measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Time Frame
after 10 weeks of intervention
Secondary Outcome Measure Information:
Title
Maternal Intrusiveness
Description
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Time Frame
after 10 weeks of intervention
Title
Maternal Sensitivity
Description
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Time Frame
24 week follow-up
Title
Maternal Intrusiveness
Description
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Time Frame
24 week follow-up
Title
Dyadic reciprocity
Description
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Time Frame
after 10 weeks of intervention
Title
Dyadic reciprocity
Description
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Time Frame
24 week follow-up
Title
Negative states
Description
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Time Frame
after 10 weeks of intervention
Title
Negative states
Description
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Time Frame
24 week follow-up
Title
Child Behaviour Check List (CBCL)-Total score-parent rated
Description
Parent questionnaire on child symptoms. Score range (0-236). Higher indicates more problems.
Time Frame
after 10 weeks of intervention
Title
Child Behaviour Check List (CBCL)-Total score-parent rated
Description
Parent questionnaire on child symptoms. Score range: 0-236. Higher indicates more problems.
Time Frame
24 week follow-up
Title
CBCL-ODD score-parent rated. Score range: 0-26. Higher indicates more problems.
Description
Parent questionnaire on child symptoms
Time Frame
after 10 weeks of intervention
Title
CBCL-ODD score-parent rated. Score range: 0-26. Higher indicates more problems.
Description
Parent questionnaire on child symptoms
Time Frame
24 week follow-up
Title
Berkeley Puppet interview
Description
Child interview
Time Frame
after 10 weeks of intervention
Title
Berkeley Puppet interview
Description
Child interview
Time Frame
24 week follow-up
Title
Coping with childrens negative emotions scale
Description
Parent questionnaire on their strategies coping with children's negative emotions. Score range 72-504.
Time Frame
baseline
Title
Coping with childrens negative emotions scale
Description
Parent questionnaire on their strategies coping with children's negative emotions. Score range 72-504.
Time Frame
after 10 weeks of intervention
Title
Coping with childrens negative emotions scale
Description
Parent questionnaire on their strategies coping with children's negative emotions. Score range 72-504.
Time Frame
24 week follow-up
Title
Parental Reflective Functioning Questionnaire
Description
Parent self-report measure that assesses parental reflective functioning or mentalizing. Score range 1-126.
Time Frame
baseline
Title
Parental Reflective Functioning Questionnaire
Description
Parent self-report measure that assesses parental reflective functioning or mentalizing. Score range 1-126.
Time Frame
after 10 weeks of intervention
Title
Parental Reflective Functioning Questionnaire
Description
Parent self-report measure that assesses parental reflective functioning or mentalizing. Score range 1-126.
Time Frame
24 week follow-up
Title
Eyberg Child Behaviour Inventory (ECBI)
Description
Parent questionnaire on child behavior. Score range 36-252. Higher indicating more problems.
Time Frame
after 10 weeks of intervention
Title
Eyberg Child Behaviour Inventory (ECBI)
Description
Parent questionnaire on child behavior. Score range 36-252. Higher indicating more problems.
Time Frame
24 week follow-up
Other Pre-specified Outcome Measures:
Title
Major Depression Inventory- mother and partner
Description
Parent questionnaire on their own depressive symptoms. Score range 0-50. Higher scores indicating more severe symptoms.
Time Frame
baseline
Title
Revised Adult Attachment Scale (RAAS)
Description
Questionnaire regarding the attachment style of the mother and partner. Scofre range 18-90.
Time Frame
baseline
Title
Standardized Assessment of Personality (SAPAS)-mother and partner
Description
A short and simple interview-administered screen for personality disorders. Score range 1-8, higher score indicating more problems.
Time Frame
baseline
Title
Strength and Difficulties Questionnaire (SDQ)
Description
Parent questionnaire on the strength and difficulties of the child. Total difficulties score 0-40. Higher indicating more problems.
Time Frame
baseline
Title
Strength and Difficulties Questionnaire (SDQ)
Description
Parent questionnaire on the strength and difficulties of the child. Total difficulties score 0-40. Higher indicating more problems.
Time Frame
after 10 weeks of intervention
Title
Strength and Difficulties Questionnaire (SDQ)
Description
Parent questionnaire on the strength and difficulties of the child. Total difficulties score 0-40. Higher indicating more problems.
Time Frame
24 week follow-up
Title
Brief Symptom Inventory
Description
Parent questionnaire on their own symptoms. Score range 0-212. Higher indicating more problems.
Time Frame
baseline
Title
Attention Deficit Hyperactivity Disorder- Rating Scale (ADHD-RS)
Description
Parent questionnaire on child ADHD symptoms. Score range: 1-78. Higher indicates more problems.
Time Frame
after 10 weeks of intervention
Title
Attention Deficit Hyperactivity Disorder- Rating Scale (ADHD-RS)
Description
Parent questionnaire on child ADHD symptoms. Score range: 1-78. Higher indicates more problems.
Time Frame
24 weeks follow up
Title
Parental Stress Scale
Description
Parent rating scale on their stress level. Score range: 18-90. Higher scores indicate more stress.
Time Frame
after 10 weeks of intervention
Title
Parental Stress Scale
Description
Parent rating scale on their stress level. Score range: 18-90. Higher scores indicate more stress.
Time Frame
24 week follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aida Bikic, PhD
Phone
+ 45 99 44 62 00
Email
aida.bikic@rsyd.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Søren Dalsgaard, PhD
Email
sdalsgaard@econ.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aida Bikic, PhD
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Child and Adolescent Mental Health Services
City
Aabenraa
ZIP/Postal Code
6200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aida Bikic, Ph.D.
Email
aida.bikic@rsyd.dk

12. IPD Sharing Statement

Citations:
PubMed Identifier
35472058
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.
Results Reference
derived

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COS-P for Parents of Children Referred to Child Psychiatric Services

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