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

NCT03578016 | Unknown DMC

• 1 other identifier: 2008-58-0035
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Keywords

attachment; parent; training; sensitivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Maternal Intrusiveness

  after 10 weeks of intervention

• Maternal Sensitivity

  24 week follow-up

• Maternal Intrusiveness

  24 week follow-up

• Dyadic reciprocity

  after 10 weeks of intervention

• Dyadic reciprocity

  24 week follow-up

Other Outcomes (11)

• Major Depression Inventory- mother and partner

  baseline

• Revised Adult Attachment Scale (RAAS)

  baseline

• Standardized Assessment of Personality (SAPAS)-mother and partner

  baseline

Study Arms (2)

Circle of Security-Parenting

EXPERIMENTAL

10 weekly, manualized group sessions at the clinic

Other: Circle of Security-Parenting; Other: Treatment as Usual

Treatment as Usual (TAU)

OTHER

TAU consists of clinical assessment and treatment.

Other: Treatment as Usual

Interventions

Circle of Security-Parenting 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.

Also known as: COS-P

Circle of Security-Parenting

Treatment as Usual OTHER

TAU consists of clinical assessment and treatment.

Also known as: TAU

Circle of Security-Parenting; Treatment as Usual (TAU)

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Syddanmark: lead

Study Sites (1)

Department of Child and Adolescent Mental Health Services

Aabenraa, 6200, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 35472058 DERIVED

MeSH Terms

Conditions

Hypersensitivity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Aida Bikic, PhD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aida Bikic, PhD

CONTACT

+ 45 99 44 62 00; aida.bikic@rsyd.dk

Søren Dalsgaard, PhD

CONTACT

sdalsgaard@econ.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor, ph.d.

Study Record Dates

• First Submitted: April 8, 2018
• First Posted: July 5, 2018
• Study Start: August 15, 2018
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: July 14, 2020

Record last verified: 2020-07

Locations

DK (1)