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

NCT ID: NCT03578016

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-15
• Study Completion Date: 2023-12-30

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.

Conditions

Child Behavior Problem

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Circle of Security-Parenting

10 weekly, manualized group sessions at the clinic

Group Type: EXPERIMENTAL

Circle of Security-Parenting

Intervention Type: OTHER

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

Intervention Type: OTHER

TAU consists of clinical assessment and treatment.

Treatment as Usual (TAU)

TAU consists of clinical assessment and treatment.

Group Type: OTHER

Treatment as Usual

Intervention Type: OTHER

TAU consists of clinical assessment and treatment.

Interventions

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.

Intervention Type: OTHER

Treatment as Usual

TAU consists of clinical assessment and treatment.

Intervention Type: OTHER

Other Intervention Names

COS-P; TAU

Eligibility 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Syddanmark

OTHER

Sponsor Role: lead

Responsible Party

Aida Bikic

assistant professor, ph.d.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aida Bikic, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Locations

Department of Child and Adolescent Mental Health Services

Aabenraa, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Aida Bikic, PhD

Role: CONTACT

aida.bikic@rsyd.dk

+ 45 99 44 62 00

Søren Dalsgaard, PhD

Role: CONTACT

sdalsgaard@econ.au.dk

Facility Contacts

Aida Bikic, Ph.D.

Role: primary

Role: backup

aida.bikic@rsyd.dk

References

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.

Reference Type: DERIVED

PMID: 35472058 (View on PubMed)

Other Identifiers

2008-58-0035

Identifier Type: -

Identifier Source: org_study_id