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Clinical Trial Summary

The goal of this longitudinal study is to study the effects of a parenting skills group (Circle of Security Parenting, aka COSP) in mothers with postpartum depression. The main questions it aims to answer are: - Will changes in methylation of the OXTR rs53576 be apparent in mother and/or infant after having gone through the 8-week COSP program? - Will COSP participation be associated with improved symptoms of postpartum depression (over and above standard care), attachment style, and relational characteristics of the mother-infant dyad? - Will COSP participation be associated with changes in social behavior in the infant, and if so, do they persist throughout childhood? Participants will - Participate in an 8-week COSP program delivered remotely via Zoom. - Provide buccal swabs (mother and infant) to assess changes in methylation of OXTR rs53576 pre- versus post-intervention. - Complete a series of assessment questionnaires delivered remotely. - Videotape a play-based assessment in their home. - Receive infant developmental testing Researchers will compare characteristics of waitlist controls to those participating in the COSP program at the mid-way point of the program to see if the two groups differ.

Clinical Trial Description

The primary aims of this study are to 1) better understand the biological/genetic mechanisms and processes of behavior change in mothers and babies relating to oxytocin receptor gene methylation; 2) complete an outcome assessment of the efficacy of the COSP intervention using a tele-health format, specifically in relation to treating maternal depression; 3) to better understand the mechanisms and processes of change in relation to maternal and infant co-regulation achieved through the promotion of a secure attachment between mothers and their at-risk infants, and to understand how these processes form a trajectory of behavioral outcomes in kindergarten. The COSP program lasts for 8 weeks and will be delivered via Zoom. Researchers will collect a variety of data including biological samples, self-report questionnaires, developmental assessment, and direct observation to assess predictors and outcomes relating to participation in the COSP program. Data will be collected prior to starting COSP, half-way through participation, after having completed the program, and at several timepoints following completion. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05772897
Study type Interventional
Source University of Colorado, Denver
Contact Sunny Stophaeros, MS
Phone 9253392971
Status Recruiting
Phase N/A
Start date April 1, 2023
Completion date June 1, 2035

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