Parenting Skills Group for Mothers With Postpartum Depression

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Postpartum Depression

Treatments: Behavioral: Circle of Security Parenting program

Study type: Interventional

Funder types: Other

Identifiers

NCT05772897

21-2593

Details and patient eligibility

About

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.

Full 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.

Enrollment: 750 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Mothers aged 18-50 years old with infants aged 3-14 months old
• Mothers who are experiencing symptoms of depression and mothers who are not experiencing symptoms of depression (non-depressed controls) are encouraged to participate.

(please note that mothers who are experiencing active depression and who are not already being treated under the care of a qualified healthcare provider (i.e. through therapy or psychopharmacological intervention) will be referred for such treatment prior to being enrolled in the study. This study is not a replacement for professional management of depression or other mental health symptoms.

Exclusion criteria

• Mothers with severe psychopathology (such as bipolar disorder, schizophrenia, personality disorders, among others)
• Infants with major medical problems that may interfere with a mother's ability to participate in and benefit from the intervention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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750 participants in 2 patient groups

Circle of Security Parenting (COSP) group

Experimental group

Description:

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.

Treatment:

Behavioral: Circle of Security Parenting program

Waitlist Control Group

No Intervention group

Description:

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.