Child Behavior ProblemCOS-PNCT03578016
COS-P for Parents of Children Referred to Child Psychiatric Services
A study testing Circle of Security-Parenting and Treatment as Usual in people with Child Behavior Problem, run by Region Syddanmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Child Behavior Problem
- What is being tested?
- Circle of Security-Parenting and Treatment as Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Aug 2018to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- no informed consent from custody
- For parents:
- a diagnosis of schizophrenia
- bipolar disorder
- known substance abuse
- severe intellectual impairment
- suicide attempt in the past
Trial locations and contacts
1 site in 1 country.
Søren Dalsgaard, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Child and Adolescent Mental Health Services
Aabenraa, 6200
Aida Bikic, Ph.D.
aida.bikic@rsyd.dk
About this study
Official title: 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.
Read more
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.
- Conditions
- Child Behavior Problem
- Being tested
- Circle of Security-Parenting, Treatment as Usual
- Keywords
- attachment, parent, training, sensitivity
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circle of Security-ParentingOther
Also called COS-P
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.
Treatment as UsualOther
Also called TAU
TAU consists of clinical assessment and treatment.
| Study group | Role | What they receive |
|---|---|---|
| Circle of Security-Parenting | Experimental | 10 weekly, manualized group sessions at the clinic Receives: Other: Circle of Security-Parenting; Other: Treatment as Usual |
| Treatment as Usual (TAU) | Other | TAU consists of clinical assessment and treatment. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal sensitivity
Maternal sensitivity is measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Measured: after 10 weeks of intervention
Secondary outcomes (21)
Maternal Intrusiveness
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Measured: after 10 weeks of intervention
Maternal Sensitivity
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Measured: 24 week follow-up
Maternal Intrusiveness
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Measured: 24 week follow-up
Dyadic reciprocity
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Measured: after 10 weeks of intervention
Dyadic reciprocity
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Measured: 24 week follow-up
Negative states
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Measured: after 10 weeks of intervention
Negative states
Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)
Measured: 24 week follow-up
Child Behaviour Check List (CBCL)-Total score-parent rated
Parent questionnaire on child symptoms. Score range (0-236). Higher indicates more problems.
Measured: after 10 weeks of intervention
Child Behaviour Check List (CBCL)-Total score-parent rated
Parent questionnaire on child symptoms. Score range: 0-236. Higher indicates more problems.
Measured: 24 week follow-up
CBCL-ODD score-parent rated. Score range: 0-26. Higher indicates more problems.
Parent questionnaire on child symptoms
Measured: after 10 weeks of intervention
CBCL-ODD score-parent rated. Score range: 0-26. Higher indicates more problems.
Parent questionnaire on child symptoms
Measured: 24 week follow-up
Berkeley Puppet interview
Child interview
Measured: after 10 weeks of intervention
Berkeley Puppet interview
Child interview
Measured: 24 week follow-up
Coping with childrens negative emotions scale
Parent questionnaire on their strategies coping with children's negative emotions. Score range 72-504.
Measured: baseline
Coping with childrens negative emotions scale
Parent questionnaire on their strategies coping with children's negative emotions. Score range 72-504.
Measured: after 10 weeks of intervention
Coping with childrens negative emotions scale
Parent questionnaire on their strategies coping with children's negative emotions. Score range 72-504.
Measured: 24 week follow-up
Parental Reflective Functioning Questionnaire
Parent self-report measure that assesses parental reflective functioning or mentalizing. Score range 1-126.
Measured: baseline
Parental Reflective Functioning Questionnaire
Parent self-report measure that assesses parental reflective functioning or mentalizing. Score range 1-126.
Measured: after 10 weeks of intervention
Parental Reflective Functioning Questionnaire
Parent self-report measure that assesses parental reflective functioning or mentalizing. Score range 1-126.
Measured: 24 week follow-up
Eyberg Child Behaviour Inventory (ECBI)
Parent questionnaire on child behavior. Score range 36-252. Higher indicating more problems.
Measured: after 10 weeks of intervention
Eyberg Child Behaviour Inventory (ECBI)
Parent questionnaire on child behavior. Score range 36-252. Higher indicating more problems.
Measured: 24 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start15 Aug 2018
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child Behavior ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Syddanmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aida Bikic, Region Syddanmark
- Investigators
- Aida Bikic, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578016
- Sponsor's protocol ID
- 2008-58-0035
- Acronym
- COS-P
- Status last verified
- Jul 2020
- First submitted
- 8 Apr 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35472058
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized and Controlled Trial Using Circle of Security-Parenting for Parents of Children Referred to Child Psychiatric Services.
- ClinicalTrials.gov ID
- NCT03578016
- Acronym / sponsor ID
- COS-P / 2008-58-0035
- Conditions
- Child Behavior Problem
- Keywords
- attachment, parent, training, sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Region SyddanmarkUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Circle of Security-Parenting | Experimental | Other: Circle of Security-Parenting, Other: Treatment as Usual10 weekly, manualized group sessions at the clinic |
| Treatment as Usual (TAU) | Other | Other: Treatment as UsualTAU consists of clinical assessment and treatment. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- autism spectrum disorders
- serious psychopathology requiring immediate clinical attention
- head injury or verified neurological disease
- intelligence quotient (IQ) <80
- medical condition, requiring treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circle of Security-ParentingAlso: COS-PCOS-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 | Circle of Security-Parenting |
| Treatment as UsualAlso: TAUTAU consists of clinical assessment and treatment. | Other | Circle of Security-Parenting, Treatment as Usual (TAU) |
Primary outcome
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)
21 secondary outcomes
Maternal Intrusiveness
Time frame: after 10 weeks of intervention
Maternal Sensitivity
Time frame: 24 week follow-up
Maternal Intrusiveness
Time frame: 24 week follow-up
Dyadic reciprocity
Time frame: after 10 weeks of intervention
Dyadic reciprocity
Time frame: 24 week follow-up
Negative states
Time frame: after 10 weeks of intervention
Negative states
Time frame: 24 week follow-up
Child Behaviour Check List (CBCL)-Total score-parent rated
Time frame: after 10 weeks of intervention
Child Behaviour Check List (CBCL)-Total score-parent rated
Time frame: 24 week follow-up
CBCL-ODD score-parent rated. Score range: 0-26. Higher indicates more problems.
Time frame: after 10 weeks of intervention
CBCL-ODD score-parent rated. Score range: 0-26. Higher indicates more problems.
Time frame: 24 week follow-up
Berkeley Puppet interview
Time frame: after 10 weeks of intervention
Berkeley Puppet interview
Time frame: 24 week follow-up
Coping with childrens negative emotions scale
Time frame: baseline
Coping with childrens negative emotions scale
Time frame: after 10 weeks of intervention
Coping with childrens negative emotions scale
Time frame: 24 week follow-up
Parental Reflective Functioning Questionnaire
Time frame: baseline
Parental Reflective Functioning Questionnaire
Time frame: after 10 weeks of intervention
Parental Reflective Functioning Questionnaire
Time frame: 24 week follow-up
Eyberg Child Behaviour Inventory (ECBI)
Time frame: after 10 weeks of intervention
Eyberg Child Behaviour Inventory (ECBI)
Time frame: 24 week follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Derived from this study: PubMed 35472058Bikic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Søren Dalsgaard, PhD contact
Aida Bikic, PhD principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circle of Security-Parenting and Treatment as Usual in people with Child Behavior Problem, run by Region Syddanmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aida Bikic, PhD (+ 45 99 44 62 00, aida.bikic@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal sensitivity (time frame: after 10 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03578016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.