Parenting Skills Group for Mothers With Postpartum Depression

Part of paid clinical trials in Denver, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05772897
Status
Recruiting
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Conditions

  • Postpartum Depression

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Circle of Security Parenting program — BEHAVIORAL
    The Circle of Security Parenting (COSP) program is an 8- week group parenting course that was designed using decades of attachment research to foster a secure attachment by teaching parents to read and respond to infant cues, and to recognize the interplay between their own psychological and emotional experiences and the emotional regulation of their infants. The COSP program provides parents with relationship tools and techniques for understanding their children's needs in new ways that provide lasting security for the child and more satisfaction for the parent. There are two major themes in the program: 1) teaching parents how to read their children's behavior and use it as a guide for meeting their needs and 2) helping parents to understand how their own early attachment relationships have influenced them as a person, and how those influences show up in their parenting and impact their ability to help regulate their child and respond to their needs.

Study Details

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.

Key Dates

Start date
Aug 3, 2023
Status verified
Nov 2023
Primary completion
Apr 1, 2035
Completion
Jun 1, 2035

Study Design

Enrollment
750 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Circle of Security Parenting (COSP) group
    This group of mothers will be assigned to begin the parenting skills intervention (COSP) group soon after enrollment, and data collection (developmental testing, buccal swabs, play-based assessment, questionnaires) will proceed as planned. COSP groups will be conducted remotely via Zoom.
  • No Intervention: Waitlist Control Group
    This group of mothers will be assigned to a waitlist control group and will be scheduled to begin the parenting skills group at a later time. In order to serve as a no-intervention control, they will be administered assessments while on the waiting list. These assessments will be given concurrently with mid-point assessment of the intervention group.

Primary Outcome Measure

Change in methylation of OXTR receptor gene rs53576 [ Time Frame: Time1 (baseline), Time4 (1 week post-intervention), Time5 (6 months post-intervention), Time6 (12 months post-intervention) Time7 (average 4.5 years post-intervention) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado DenverDenverColorado80204
Sunny Stophaeros, MS
[email protected]
925-339-2971
Caroline R Harrison, MPH
[email protected]
2028129299
Sunny Stophaeros, MS (PRINCIPAL_INVESTIGATOR)
Kevin Everhart, PhD (SUB_INVESTIGATOR)
Caroline Harrison, MPH (SUB_INVESTIGATOR)
Peter Kaplan, PhD (SUB_INVESTIGATOR)

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By research site
University of Colorado Denver· Denver, CO

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