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

July 13, 2020 updated by: Aida Bikic, Region Syddanmark

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

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Aabenraa, Denmark, 6200
        • Recruiting
        • Department of Child and Adolescent Mental Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • COS-P
TAU consists of clinical assessment and treatment.
Other Names:
  • TAU
Other: Treatment as Usual (TAU)
TAU consists of clinical assessment and treatment.
TAU consists of clinical assessment and treatment.
Other Names:
  • TAU

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)
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
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
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
Parent questionnaire on their strategies coping with children's negative emotions. Score range 72-504.
baseline
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
Coping with childrens negative emotions scale
Time Frame: 24 week follow-up
Parent questionnaire on their strategies coping with children's negative emotions. Score range 72-504.
24 week follow-up
Parental Reflective Functioning Questionnaire
Time Frame: baseline
Parent self-report measure that assesses parental reflective functioning or mentalizing. Score range 1-126.
baseline
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
Standardized Assessment of Personality (SAPAS)-mother and partner
Time Frame: baseline
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
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.
after 10 weeks of intervention
Strength and Difficulties Questionnaire (SDQ)
Time Frame: 24 week follow-up
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
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.
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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Aida Bikic, PhD, University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2018

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

April 8, 2018

First Submitted That Met QC Criteria

June 22, 2018

First Posted (Actual)

July 5, 2018

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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