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

Study Overview
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Brief Summary
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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.

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

Conditions
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Child Behavior Problem

Intervention / Treatment
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* Other: Circle of Security-Parenting
* Other: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Circle of Security-Parenting<br>10 weekly, manualized group sessions at the clinic | Other: Circle of Security-Parenting<br>* 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.<br>* Other names: COS-P;Other: Treatment as Usual<br>* TAU consists of clinical assessment and treatment.<br>* Other names: TAU;|
| Other: Treatment as Usual (TAU)<br>TAU consists of clinical assessment and treatment. | Other: Treatment as Usual<br>* TAU consists of clinical assessment and treatment.<br>* Other names: TAU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal sensitivity | 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 | Measured by observing a mother-child interaction and is rated using Coding Interactive Behavior (CIB) | after 10 weeks of intervention | 
| Maternal Sensitivity | Measured by observing a mother-child interaction and is rated using Coding Interactive Behavior (CIB) | 24 week follow-up | 
| Maternal Intrusiveness | Measured by observing a mother-child interaction and is rated using Coding Interactive Behavior (CIB) | 24 week follow-up | 
| Dyadic reciprocity | Measured by observing a mother-child interaction and is rated using Coding Interactive Behavior (CIB) | after 10 weeks of intervention | 
| Dyadic reciprocity | Measured by observing a mother-child interaction and is rated using Coding Interactive Behavior (CIB) | 24 week follow-up | 
| Negative states | Measured by observing a mother-child interaction and is rated using Coding Interactive Behavior (CIB) | after 10 weeks of intervention | 
| Negative states | 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 | 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 | 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. | Parent questionnaire on child symptoms | after 10 weeks of intervention | 
| CBCL-ODD score-parent rated. Score range: 0-26. Higher indicates more problems. | Parent questionnaire on child symptoms | 24 week follow-up | 
| Berkeley Puppet interview | Child interview | after 10 weeks of intervention | 
| Berkeley Puppet interview | Child interview | 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. | baseline | 
| Coping with childrens negative emotions scale | 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 | Parent questionnaire on their strategies coping with children's negative emotions. Score range 72-504. | 24 week follow-up | 
| Parental Reflective Functioning Questionnaire | Parent self-report measure that assesses parental reflective functioning or mentalizing. Score range 1-126. | baseline | 
| Parental Reflective Functioning Questionnaire | Parent self-report measure that assesses parental reflective functioning or mentalizing. Score range 1-126. | after 10 weeks of intervention | 
| Parental Reflective Functioning Questionnaire | Parent self-report measure that assesses parental reflective functioning or mentalizing. Score range 1-126. | 24 week follow-up | 
| Eyberg Child Behaviour Inventory (ECBI) | Parent questionnaire on child behavior. Score range 36-252. Higher indicating more problems. | after 10 weeks of intervention | 
| Eyberg Child Behaviour Inventory (ECBI) | Parent questionnaire on child behavior. Score range 36-252. Higher indicating more problems. | 24 week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parent, attachment, training, sensitivity