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Parenting Skills Group for Mothers With Postpartum Depression

Primary Purpose

Postpartum Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Circle of Security Parenting program
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts 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

Sites / Locations

  • University of Colorado DenverRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Circle of Security Parenting (COSP) group

Waitlist Control Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in methylation of OXTR receptor gene rs53576
Buccal swabs from mother and infant
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.
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.
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.

Secondary Outcome Measures

Changes in Denver Maternal Stress Assessment Score
The Denver Maternal Stress Assessment consists of 13 questions regarding a mothers stress, social support, and health behaviors, along with an inventory of different types of stress encountered in the past year. Results provide qualitative data relating to these categories.
Changes in MacArthur Short Form Vocabulary Checklist Score (child)
The infant short form (Level I, for 8- to 18-month-olds) contains an 89-word checklist for vocabulary comprehension and production.
Changes in Maternal Postnatal Attachment Scale (MPAS) Score
The Maternal Postnatal Attachment Scale (MPAS) is a 19 item self-report questionnaire that is used to assess mother-to-infant attachment. According to the authors, parent-to-infant attachment refers to "the emotional bond or tie of affection experienced by the parent towards the infant" (Condon & Corkingdale, 1998). Items are scored on a scale of 1-5, with item totals summed to obtain a scaled score. Lower scores indicate lower attachment and higher scores higher attachment.
Changes in The Multidimensional Scale of Perceived Social Support (MSPSS) Score
The Multidimensional Scale of Perceived Social Support (Zimet et al., 1988) is a 12-item measure of perceived adequacy of social support from three sources: family, friends, & significant other; using a 5-point Likert scale (0 = strongly disagree, 5 = strongly agree).
Changes in Carey Infant Temperament Questionnaire (ITQ) Score
The Carey Temperament Scales are parent report questionnaires that determine behavioral style in each of nine categories of temperament in infants, toddlers, and children up to age 13 years old. Temperament is divided into categories of "easy," "intermediate low" "intermediate high," and "difficult," with lower scores indicating easy temperament and higher indicating more difficult temperament.
Empathy & Theory of Mind Scale (EToMS) Score
The Empathy and Theory of Mind Scale (EToMS) is a 17-item measure that was created to assess three specific facets of children's social functioning (empathy, prosocial behaviors that employ theory of mind ability ("Nice" TOM), and antisocial behaviors that employ theory of mind ability ("Nasty" TOM) (Wang & Wang, 2015). This measure was developed to provide an evaluation of children's empathic ability and understanding of epistemic mental states, as well as their prosocial or antisocial behaviors.
Inventory of Callous-Unemotional Traits (ICU) Score
The ICU is a 24-item measure that was created to assess three specific facets of affective functioning (callousness, level of care for others, and level of emotionality). These three factors have been shown to differentiate a unique subgroup of individuals who are most at risk for severe antisocial behavior.

Full Information

First Posted
February 8, 2023
Last Updated
June 26, 2023
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT05772897
Brief Title
Parenting Skills Group for Mothers With Postpartum Depression
Official Title
Effects of Attachment-Focused Parenting Intervention on Postpartum Depression and Biological Markers of Stress in Mothers and Their Infants
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Anticipated)
Primary Completion Date
April 1, 2035 (Anticipated)
Study Completion Date
June 1, 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Circle of Security Parenting (COSP) group
Arm Type
Experimental
Arm 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.
Arm Title
Waitlist Control Group
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Circle of Security Parenting program
Other Intervention Name(s)
COSP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in methylation of OXTR receptor gene rs53576
Description
Buccal swabs from mother and infant
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)
Title
Changes in Beck Depression Inventory, Second Edition (BDI-II) Score
Description
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.
Time Frame
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)
Title
Changes Postpartum Depression Screening Scale (PDSS) Score
Description
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.
Time Frame
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)
Title
Changes in Dyadic Adjustment Scale (DAS) Score
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Changes in Denver Maternal Stress Assessment Score
Description
The Denver Maternal Stress Assessment consists of 13 questions regarding a mothers stress, social support, and health behaviors, along with an inventory of different types of stress encountered in the past year. Results provide qualitative data relating to these categories.
Time Frame
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)
Title
Changes in MacArthur Short Form Vocabulary Checklist Score (child)
Description
The infant short form (Level I, for 8- to 18-month-olds) contains an 89-word checklist for vocabulary comprehension and production.
Time Frame
Time1 (baseline), Time5 (6 months post-intervention), Time6 (12 months post-intervention)
Title
Changes in Maternal Postnatal Attachment Scale (MPAS) Score
Description
The Maternal Postnatal Attachment Scale (MPAS) is a 19 item self-report questionnaire that is used to assess mother-to-infant attachment. According to the authors, parent-to-infant attachment refers to "the emotional bond or tie of affection experienced by the parent towards the infant" (Condon & Corkingdale, 1998). Items are scored on a scale of 1-5, with item totals summed to obtain a scaled score. Lower scores indicate lower attachment and higher scores higher attachment.
Time Frame
Time1 (baseline), Time2 (1 week pre-intervention), Time4 (1 week post-intervention), Time5 (6 months post-intervention), Time6 (12 months post-intervention)
Title
Changes in The Multidimensional Scale of Perceived Social Support (MSPSS) Score
Description
The Multidimensional Scale of Perceived Social Support (Zimet et al., 1988) is a 12-item measure of perceived adequacy of social support from three sources: family, friends, & significant other; using a 5-point Likert scale (0 = strongly disagree, 5 = strongly agree).
Time Frame
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)
Title
Changes in Carey Infant Temperament Questionnaire (ITQ) Score
Description
The Carey Temperament Scales are parent report questionnaires that determine behavioral style in each of nine categories of temperament in infants, toddlers, and children up to age 13 years old. Temperament is divided into categories of "easy," "intermediate low" "intermediate high," and "difficult," with lower scores indicating easy temperament and higher indicating more difficult temperament.
Time Frame
Time1 (baseline), Time5 (6 months post-intervention), Time6 (12 months post-intervention), Time7 (average 4.5 years post-intervention)
Title
Empathy & Theory of Mind Scale (EToMS) Score
Description
The Empathy and Theory of Mind Scale (EToMS) is a 17-item measure that was created to assess three specific facets of children's social functioning (empathy, prosocial behaviors that employ theory of mind ability ("Nice" TOM), and antisocial behaviors that employ theory of mind ability ("Nasty" TOM) (Wang & Wang, 2015). This measure was developed to provide an evaluation of children's empathic ability and understanding of epistemic mental states, as well as their prosocial or antisocial behaviors.
Time Frame
Time7 (average 4.5 years post-intervention)
Title
Inventory of Callous-Unemotional Traits (ICU) Score
Description
The ICU is a 24-item measure that was created to assess three specific facets of affective functioning (callousness, level of care for others, and level of emotionality). These three factors have been shown to differentiate a unique subgroup of individuals who are most at risk for severe antisocial behavior.
Time Frame
Time7 (average 4.5 years post-intervention)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sunny Stophaeros, MS
Phone
9253392971
Email
sunny.stophaeros@ucdenver.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline R Harrison, MPH
Email
caroline.harrison@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunny Stophaeros, MS
Organizational Affiliation
sunny.stophaeros@ucdenver.edu
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunny Stophaeros, MS
Phone
925-339-2971
Email
sunny.stophaeros@ucdenver.edu
First Name & Middle Initial & Last Name & Degree
Caroline R Harrison, MPH
Phone
2028129299
Email
caroline.harrison@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Sunny Stophaeros, MS
First Name & Middle Initial & Last Name & Degree
Kevin Everhart, PhD
First Name & Middle Initial & Last Name & Degree
Caroline Harrison, MPH
First Name & Middle Initial & Last Name & Degree
Peter Kaplan, PhD

12. IPD Sharing Statement

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Parenting Skills Group for Mothers With Postpartum Depression

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