Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
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Protocol for a randomized controlled trial comparing the Circle of Security-parenting (COS-P) with treatment as usual in child mental health services.

BACKGROUND: The quality of a child's attachment to its primary caregiver plays an important role for its long-term socioemotional development. While 'secure' attachment is associated with better outcomes, 'insecure' attachment is associated with a higher risk of externalizing and internalizing symptoms. Children referred to mental health services show much higher rates of insecure attachment than the general population, yet the parent-child relationship is rarely in treatment focus. Attachment quality is closely associated with parental sensitive responsiveness that is target of attachment-based interventions like Circle of Security (COS). COS has shown to improve attachment quality and the well-being of both children and parents. No randomized controlled trials have investigated the effect of COS on parental sensitivity and child psychiatric symptoms in child mental health services.

OBJECTIVES: To investigate whether COS-Parenting (COS-P) can increase observed maternal sensitivity and decrease children's psychiatric symptoms as an add on to treatment as usual (TAU).

METHODS: In a randomized controlled parallel superiority trial COS-P is compared with TAU for parents of children referred to child mental health services (n = 186). Families are randomized 2:1 to intervention or control group, if their child is between 3 and 8 years old and scores ≥ 93d percentile on both the CBCL total score and the oppositional defiant disorder or conduct disorder subscale. Primary outcome is maternal sensitivity, secondary and exploratory outcomes include, among others, child psychiatric symptoms, parental stress and coping with children's negative emotions. Outcomes and adverse events are assessed before (T0) and after 10 weeks of treatment (T1) and 6 months later (T2). Regression analysis and /or ANOVA will be used for all outcomes.

PERSPECTIVES: Targeting the parent-child relation has the potential to reduce psychiatric symptoms in children. This trial will provide valuable information if attachment-based interventions like COS-P can enhance treatment as usual in child mental health services.

TRAIL REGISTRATION: ClinicalTrials.gov Identifier: NCT03578016.

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