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

Sponsor
Region Syddanmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT03578016
Collaborator
(none)
128
1
2
64.5
2

Study Details

Study Description

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
  • Other: Circle of Security-Parenting
  • Other: Treatment as Usual
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Aug 15, 2018
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

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

    TAU consists of clinical assessment and treatment.

    Other: Treatment as Usual
    TAU consists of clinical assessment and treatment.
    Other Names:
  • TAU
  • Outcome Measures

    Primary Outcome Measures

    1. Maternal sensitivity [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 [after 10 weeks of intervention]

      Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)

    2. Maternal Sensitivity [24 week follow-up]

      Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)

    3. Maternal Intrusiveness [24 week follow-up]

      Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)

    4. Dyadic reciprocity [after 10 weeks of intervention]

      Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)

    5. Dyadic reciprocity [24 week follow-up]

      Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)

    6. Negative states [after 10 weeks of intervention]

      Measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)

    7. Negative states [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 [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 [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. [after 10 weeks of intervention]

      Parent questionnaire on child symptoms

    11. CBCL-ODD score-parent rated. Score range: 0-26. Higher indicates more problems. [24 week follow-up]

      Parent questionnaire on child symptoms

    12. Berkeley Puppet interview [after 10 weeks of intervention]

      Child interview

    13. Berkeley Puppet interview [24 week follow-up]

      Child interview

    14. Coping with childrens negative emotions scale [baseline]

      Parent questionnaire on their strategies coping with children's negative emotions. Score range 72-504.

    15. Coping with childrens negative emotions scale [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 [24 week follow-up]

      Parent questionnaire on their strategies coping with children's negative emotions. Score range 72-504.

    17. Parental Reflective Functioning Questionnaire [baseline]

      Parent self-report measure that assesses parental reflective functioning or mentalizing. Score range 1-126.

    18. Parental Reflective Functioning Questionnaire [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 [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) [after 10 weeks of intervention]

      Parent questionnaire on child behavior. Score range 36-252. Higher indicating more problems.

    21. Eyberg Child Behaviour Inventory (ECBI) [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 [baseline]

      Parent questionnaire on their own depressive symptoms. Score range 0-50. Higher scores indicating more severe symptoms.

    2. Revised Adult Attachment Scale (RAAS) [baseline]

      Questionnaire regarding the attachment style of the mother and partner. Scofre range 18-90.

    3. Standardized Assessment of Personality (SAPAS)-mother and partner [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) [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) [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) [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 [baseline]

      Parent questionnaire on their own symptoms. Score range 0-212. Higher indicating more problems.

    8. Attention Deficit Hyperactivity Disorder- Rating Scale (ADHD-RS) [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) [24 weeks follow up]

      Parent questionnaire on child ADHD symptoms. Score range: 1-78. Higher indicates more problems.

    10. Parental Stress Scale [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 [24 week follow up]

      Parent rating scale on their stress level. Score range: 18-90. Higher scores indicate more stress.

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Child and Adolescent Mental Health Services Aabenraa Denmark 6200

    Sponsors and Collaborators

    • Region Syddanmark

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aida Bikic, assistant professor, ph.d., Region Syddanmark
    ClinicalTrials.gov Identifier:
    NCT03578016
    Other Study ID Numbers:
    • 2008-58-0035
    First Posted:
    Jul 5, 2018
    Last Update Posted:
    Jul 14, 2020
    Last Verified:
    Jul 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Aida Bikic, assistant professor, ph.d., Region Syddanmark
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 14, 2020