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

Child Behavior Problem Clinical Trial

— COS-P  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03578016
• Other study ID #: 2008-58-0035
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2020
• Source: Region Syddanmark
• Contact: Aida Bikic, PhD
• Phone: + 45 99 44 62 00
• Email: aida.bikic[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Behavior Problem
• Problem Behavior

Intervention

Other:
• Circle of Security-Parenting
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 Usual
TAU consists of clinical assessment and treatment.

Locations

Country	Name	City	State
Denmark	Department of Child and Adolescent Mental Health Services	Aabenraa

Sponsors (1)

Lead Sponsor	Collaborator
Region Syddanmark

Country where clinical trial is conducted

Denmark, 

Outcome

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