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

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ClinicalTrials.gov Identifier: NCT03578016
Recruitment Status : Recruiting
First Posted : July 4, 2018
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Aida Bikic, Region Syddanmark

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.


Condition or disease Intervention/treatment Phase
Child Behavior Problem Other: Circle of Security-Parenting Other: Treatment as Usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized and Controlled Trial Using Circle of Security-Parenting for Parents of Children Referred to Child Psychiatric Services.
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arm Intervention/treatment
Experimental: Circle of Security-Parenting
10 weekly, manualized group sessions at the clinic
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.
Other Name: COS-P

Other: Treatment as Usual
TAU consists of clinical assessment and treatment.
Other Name: TAU

Treatment as Usual (TAU)
TAU consists of clinical assessment and treatment.
Other: Treatment as Usual
TAU consists of clinical assessment and treatment.
Other Name: TAU




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Maternal Intrusiveness [ Time Frame: after 10 weeks of intervention ]
    Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)

  2. Maternal Sensitivity [ Time Frame: 24 week follow-up ]
    Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)

  3. Maternal Intrusiveness [ Time Frame: 24 week follow-up ]
    Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)

  4. Dyadic reciprocity [ Time Frame: after 10 weeks of intervention ]
    Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)

  5. Dyadic reciprocity [ Time Frame: 24 week follow-up ]
    Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)

  6. Negative states [ Time Frame: after 10 weeks of intervention ]
    Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)

  7. Negative states [ Time Frame: 24 week follow-up ]
    Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)

  8. 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.

  9. 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.

  10. 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

  11. CBCL-ODD score-parent rated. Score range: 0-26. Higher indicates more problems. [ Time Frame: 24 week follow-up ]
    Parent questionnaire on child symptoms

  12. Berkeley Puppet interview [ Time Frame: after 10 weeks of intervention ]
    Child interview

  13. Berkeley Puppet interview [ Time Frame: 24 week follow-up ]
    Child interview

  14. Coping with childrens negative emotions scale [ Time Frame: baseline ]
    Parent questionnaire on their strategies coping with children's negative emotions. Score range 72-504.

  15. 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.

  16. 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.

  17. Parental Reflective Functioning Questionnaire [ Time Frame: baseline ]
    Parent self-report measure that assesses parental reflective functioning or mentalizing. Score range 1-126.

  18. 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.

  19. 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.

  20. 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.

  21. Eyberg Child Behaviour Inventory (ECBI) [ Time Frame: 24 week follow-up ]
    Parent questionnaire on child behavior. Score range 36-252. Higher indicating more problems.


Other Outcome Measures:
  1. 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.

  2. Revised Adult Attachment Scale (RAAS) [ Time Frame: baseline ]
    Questionnaire regarding the attachment style of the mother and partner. Scofre range 18-90.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Brief Symptom Inventory [ Time Frame: baseline ]
    Parent questionnaire on their own symptoms. Score range 0-212. Higher indicating more problems.

  8. 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.

  9. 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.

  10. 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.

  11. 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.



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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578016


Contacts
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Contact: Aida Bikic, PhD + 45 99 44 62 00 aida.bikic@rsyd.dk
Contact: Søren Dalsgaard, PhD sdalsgaard@econ.au.dk

Locations
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Denmark
Department of Child and Adolescent Mental Health Services Recruiting
Aabenraa, Denmark, 6200
Contact: Aida Bikic, Ph.D.         
Contact       aida.bikic@rsyd.dk   
Sponsors and Collaborators
Region Syddanmark
Investigators
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Principal Investigator: Aida Bikic, PhD University of Southern Denmark

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Responsible Party: Aida Bikic, assistant professor, ph.d., Region Syddanmark
ClinicalTrials.gov Identifier: NCT03578016     History of Changes
Other Study ID Numbers: 2008-58-0035
First Posted: July 4, 2018    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aida Bikic, Region Syddanmark:
attachment
parent
training
sensitivity

Additional relevant MeSH terms:
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Problem Behavior
Behavioral Symptoms