Parenting Skills Group for Mothers With Postpartum Depression

NCT05772897 | Recruiting

• 1 other identifier: 21-2593
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Depression

Outcome Measures

Primary Outcomes (4)

• Change in methylation of OXTR receptor gene rs53576

  Buccal swabs from mother and infant

  Time1 (baseline), Time4 (1 week post-intervention), Time5 (6 months post-intervention), Time6 (12 months post-intervention) Time7 (average 4.5 years post-intervention)

• Changes in Beck Depression Inventory, Second Edition (BDI-II) Score

  The BDI-II is a brief, self-report inventory designed to measure the severity of depression symptomatology for ages 13-80 years old and takes approximately 5 minutes to complete. The BDI-II is comprised of 21 items. Each item is scored on a scale of 0 to 3, with a total score range of 0-63. Total score of \<14 indicates minimal range, 14-19 indicates mild severity, 20-28 indicates moderate severity, and 29-63 indicates a score in the severe range. Higher scores indicate greater levels of depression.

  Time1 (baseline), Time2 (1 week pre-intervention), Time3 (week 5 of intervention), Time4 (1 week post-intervention), Time5 (6 months post-intervention), Time6 (12 months post-intervention), Time7 (average 4.5 years post-intervention)

• Changes Postpartum Depression Screening Scale (PDSS) Score

  The PDSS is a 35-item self-report measure helps clinicians identify mothers suffering from postpartum depression. It takes about 5-10 minutes to complete and is written at a third-grade reading level. Mothers respond using a 5-point scale ranging from "strongly disagree" to "strongly agree" and yields an overall severity score. A higher score indicates more severe depression.

  Time1 (baseline), Time2 (1 week pre-intervention), Time3 (week 5 of intervention), Time4 (1 week post-intervention), Time5 (6 months post-intervention), Time6 (12 months post-intervention)

• Changes in Dyadic Adjustment Scale (DAS) Score

  A 32-item measure of relationship quality. The scale is divided into 4 subscales: (1) Dyadic Consensus - degree to which respondent agrees with partner (2) Dyadic Satisfaction -- degree to which respondent feels satisfied with partner (3) Dyadic Cohesion -degree to which respondent and partner participate in activities together (4) Affectional Expression -degree to which respondent agrees with partner regarding emotional affection. Scores range from 0-151, with higher scores being indicative of more positive dyadic adjustment and lower distress level.

  Time1 (baseline), Time2 (1 week pre-intervention), Time3 (week 5 of intervention), Time4 (1 week post-intervention), Time5 (6 months post-intervention), Time6 (12 months post-intervention), Time7 (average 4.5 years post-intervention)

Secondary Outcomes (7)

• Changes in Denver Maternal Stress Assessment Score

  Time1 (baseline), Time2 (1 week pre-intervention), Time3 (week 5 of intervention), Time4 (1 week post-intervention), Time5 (6 months post-intervention), Time6 (12 months post-intervention), Time7 (average 4.5 years post-intervention)

• Changes in MacArthur Short Form Vocabulary Checklist Score (child)

  Time1 (baseline), Time5 (6 months post-intervention), Time6 (12 months post-intervention)

• Changes in Maternal Postnatal Attachment Scale (MPAS) Score

  Time1 (baseline), Time2 (1 week pre-intervention), Time4 (1 week post-intervention), Time5 (6 months post-intervention), Time6 (12 months post-intervention)

• Changes in The Multidimensional Scale of Perceived Social Support (MSPSS) Score

  Time1 (baseline), Time2 (1 week pre-intervention), Time3 (week 5 of intervention), Time4 (1 week post-intervention), Time5 (6 months post-intervention), Time6 (12 months post-intervention), Time7 (average 4.5 years post-intervention)

• Changes in Carey Infant Temperament Questionnaire (ITQ) Score

  Time1 (baseline), Time5 (6 months post-intervention), Time6 (12 months post-intervention), Time7 (average 4.5 years post-intervention)

Study Arms (2)

Circle of Security Parenting (COSP) group

EXPERIMENTAL

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.

Behavioral: Circle of Security Parenting program

Waitlist Control Group

NO INTERVENTION

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.

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.

Also known as: COSP

Circle of Security Parenting (COSP) group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver

Denver, Colorado, 80204, United States

RECRUITING

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MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Sunny Stophaeros, MS

  sunny.stophaeros@ucdenver.edu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sunny Stophaeros, MS

CONTACT

9253392971; sunny.stophaeros@ucdenver.edu

Caroline R Harrison, MPH

CONTACT

caroline.harrison@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will ultimately receive the parenting group intervention. A waitlist control design will be implemented to compare outcomes between those not having received the intervention yet and those having completed it. Data collection will occur pre-intervention, immediately post-intervention, at 6 months post-intervention, at 12 months post-intervention, and at approximately 5 years post-intervention (when child is school-aged).

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 16, 2023
• Study Start: August 3, 2023
• Primary Completion (Estimated): April 1, 2035
• Study Completion (Estimated): June 1, 2035
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

US (1)