Parenting Skills Group for Mothers With Postpartum Depression

Postpartum Depression Clinical Trial

Official title:

Effects of Attachment-Focused Parenting Intervention on Postpartum Depression and Biological Markers of Stress in Mothers and Their Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772897
• Other study ID #: 21-2593
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2023
• Est. completion date: June 1, 2035

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: Sunny Stophaeros, MS
• Phone: 9253392971
• Email: sunny.stophaeros[@]ucdenver.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: June 1, 2035
• Est. primary completion date: April 1, 2035
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

Behavioral:
• Circle of Security Parenting program
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.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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.	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	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.	Time1 (baseline), Time5 (6 months post-intervention), Time6 (12 months post-intervention)
Secondary	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.	Time1 (baseline), Time2 (1 week pre-intervention), Time4 (1 week post-intervention), Time5 (6 months post-intervention), Time6 (12 months post-intervention)
Secondary	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).	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	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.	Time1 (baseline), Time5 (6 months post-intervention), Time6 (12 months post-intervention), Time7 (average 4.5 years post-intervention)
Secondary	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.	Time7 (average 4.5 years post-intervention)
Secondary	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.	Time7 (average 4.5 years post-intervention)