Parenting Skills Group for Mothers With Postpartum Depression

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postpartum Depression
• Intervention / Treatment: Behavioral: Circle of Security Parenting program

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.

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sunny Stophaeros, MS; Phone Number: 9253392971; Email: sunny.stophaeros@ucdenver.edu
• Study Contact Backup: Name: Caroline R Harrison, MPH; Email: caroline.harrison@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Recruiting
      • University of Colorado Denver
      • Contact: Sunny Stophaeros, MS; Phone Number: 925-339-2971; Email: sunny.stophaeros@ucdenver.edu
      • Contact: Caroline R Harrison, MPH; Phone Number: 2028129299; Email: caroline.harrison@cuanschutz.edu
      • Principal Investigator: Sunny Stophaeros, MS
      • Sub-Investigator: Kevin Everhart, PhD
      • Sub-Investigator: Caroline Harrison, MPH
      • Sub-Investigator: Peter Kaplan, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: COSP
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Sunny Stophaeros, MS, sunny.stophaeros@ucdenver.edu

Publications and helpful links

General Publications

• Vaever MS, Smith-Nielsen J, Lange T. Copenhagen infant mental health project: study protocol for a randomized controlled trial comparing circle of security -parenting and care as usual as interventions targeting infant mental health risks. BMC Psychol. 2016 Nov 22;4(1):57. doi: 10.1186/s40359-016-0166-8.
• Kimura T, Tanizawa O, Mori K, Brownstein MJ, Okayama H. Structure and expression of a human oxytocin receptor. Nature. 1992 Apr 9;356(6369):526-9. doi: 10.1038/356526a0. Erratum In: Nature 1992 May 14;357(6374):176.
• Moses-Kolko EL, Roth EK. Antepartum and postpartum depression: healthy mom, healthy baby. J Am Med Womens Assoc (1972). 2004 Summer;59(3):181-91.
• Shonkoff JP, Boyce WT, McEwen BS. Neuroscience, molecular biology, and the childhood roots of health disparities: building a new framework for health promotion and disease prevention. JAMA. 2009 Jun 3;301(21):2252-9. doi: 10.1001/jama.2009.754.
• Kendler KS, Karkowski LM, Prescott CA. Causal relationship between stressful life events and the onset of major depression. Am J Psychiatry. 1999 Jun;156(6):837-41. doi: 10.1176/ajp.156.6.837.
• Unternaehrer E, Luers P, Mill J, Dempster E, Meyer AH, Staehli S, Lieb R, Hellhammer DH, Meinlschmidt G. Dynamic changes in DNA methylation of stress-associated genes (OXTR, BDNF ) after acute psychosocial stress. Transl Psychiatry. 2012 Aug 14;2(8):e150. doi: 10.1038/tp.2012.77.
• Garner AS, Shonkoff JP; Committee on Psychosocial Aspects of Child and Family Health; Committee on Early Childhood, Adoption, and Dependent Care; Section on Developmental and Behavioral Pediatrics. Early childhood adversity, toxic stress, and the role of the pediatrician: translating developmental science into lifelong health. Pediatrics. 2012 Jan;129(1):e224-31. doi: 10.1542/peds.2011-2662. Epub 2011 Dec 26.
• Taylor, S. E., & Broffman, J. I. (2011). Psychosocial resources: Functions, origins, and links to mental and physical health. In Advances in experimental social psychology (Vol. 44, pp. 1-57). Academic Press.
• Taylor, S. E. (2010). Health psychology. Oxford University Press.
• Darcy JM, Grzywacz JG, Stephens RL, Leng I, Clinch CR, Arcury TA. Maternal depressive symptomatology: 16-month follow-up of infant and maternal health-related quality of life. J Am Board Fam Med. 2011 May-Jun;24(3):249-57. doi: 10.3122/jabfm.2011.03.100201.
• Josefsson A, Larsson C, Sydsjo G, Nylander PO. Temperament and character in women with postpartum depression. Arch Womens Ment Health. 2007 Feb;10(1):3-7. doi: 10.1007/s00737-006-0159-3. Epub 2006 Dec 4.
• Posmontier B. Functional status outcomes in mothers with and without postpartum depression. J Midwifery Womens Health. 2008 Jul-Aug;53(4):310-8. doi: 10.1016/j.jmwh.2008.02.016.
• Cicchetti D, Rogosch FA, Toth SL, Spagnola M. Affect, cognition, and the emergence of self-knowledge in the toddler offspring of depressed mothers. J Exp Child Psychol. 1997 Dec;67(3):338-62. doi: 10.1006/jecp.1997.2412.
• Milgrom, J., Westley, D. T., & Gemmill, A. W. (2004). The mediating role of maternal responsiveness in some longer term effects of postnatal depression on infant development. Infant Behavior and Development, 27(4), 443-454.
• Child care and mother-child interaction in the first 3 years of life. NICHD Early Child Care Research Network. Dev Psychol. 1999 Nov;35(6):1399-413.
• Stanley C, Murray L, Stein A. The effect of postnatal depression on mother-infant interaction, infant response to the Still-face perturbation, and performance on an Instrumental Learning task. Dev Psychopathol. 2004 Winter;16(1):1-18. doi: 10.1017/s0954579404044384.
• Muzik M, Borovska S. Perinatal depression: implications for child mental health. Ment Health Fam Med. 2010 Dec;7(4):239-47.
• Slomian J, Honvo G, Emonts P, Reginster JY, Bruyere O. Consequences of maternal postpartum depression: A systematic review of maternal and infant outcomes. Womens Health (Lond). 2019 Jan-Dec;15:1745506519844044. doi: 10.1177/1745506519844044. Erratum In: Womens Health (Lond). 2019 Jan-Dec;15:1745506519854864.
• Gentile S. Untreated depression during pregnancy: Short- and long-term effects in offspring. A systematic review. Neuroscience. 2017 Feb 7;342:154-166. doi: 10.1016/j.neuroscience.2015.09.001. Epub 2015 Sep 4.
• Chaudron LH, Szilagyi PG, Campbell AT, Mounts KO, McInerny TK. Legal and ethical considerations: risks and benefits of postpartum depression screening at well-child visits. Pediatrics. 2007 Jan;119(1):123-8. doi: 10.1542/peds.2006-2122.
• Kim S, Fonagy P, Koos O, Dorsett K, Strathearn L. Maternal oxytocin response predicts mother-to-infant gaze. Brain Res. 2014 Sep 11;1580:133-42. doi: 10.1016/j.brainres.2013.10.050. Epub 2013 Nov 1.
• Breton C, Zingg HH. Expression and region-specific regulation of the oxytocin receptor gene in rat brain. Endocrinology. 1997 May;138(5):1857-62. doi: 10.1210/endo.138.5.5127.
• Inoue H, Yamasue H, Tochigi M, Abe O, Liu X, Kawamura Y, Takei K, Suga M, Yamada H, Rogers MA, Aoki S, Sasaki T, Kasai K. Association between the oxytocin receptor gene and amygdalar volume in healthy adults. Biol Psychiatry. 2010 Dec 1;68(11):1066-72. doi: 10.1016/j.biopsych.2010.07.019. Epub 2010 Sep 15.
• Tost H, Kolachana B, Hakimi S, Lemaitre H, Verchinski BA, Mattay VS, Weinberger DR, Meyer-Lindenberg A. A common allele in the oxytocin receptor gene (OXTR) impacts prosocial temperament and human hypothalamic-limbic structure and function. Proc Natl Acad Sci U S A. 2010 Aug 3;107(31):13936-41. doi: 10.1073/pnas.1003296107. Epub 2010 Jul 20.
• Furman DJ, Chen MC, Gotlib IH. Variant in oxytocin receptor gene is associated with amygdala volume. Psychoneuroendocrinology. 2011 Jul;36(6):891-7. doi: 10.1016/j.psyneuen.2010.12.004. Epub 2011 Jan 3.
• Loth E, Poline JB, Thyreau B, Jia T, Tao C, Lourdusamy A, Stacey D, Cattrell A, Desrivieres S, Ruggeri B, Fritsch V, Banaschewski T, Barker GJ, Bokde AL, Buchel C, Carvalho FM, Conrod PJ, Fauth-Buehler M, Flor H, Gallinat J, Garavan H, Heinz A, Bruehl R, Lawrence C, Mann K, Martinot JL, Nees F, Paus T, Pausova Z, Poustka L, Rietschel M, Smolka M, Struve M, Feng J, Schumann G; IMAGEN Consortium. Oxytocin receptor genotype modulates ventral striatal activity to social cues and response to stressful life events. Biol Psychiatry. 2014 Sep 1;76(5):367-76. doi: 10.1016/j.biopsych.2013.07.043. Epub 2013 Oct 8.
• Asherin RM, Everhart KD, Stophaeros SL, Vogeli JM, Fowler J, Phiel CJ, Kaplan PS. Associations between maternal depression and mother and infant oxytocin receptor gene (OXTR_rs53576) polymorphisms. Dev Psychobiol. 2020 May;62(4):496-504. doi: 10.1002/dev.21938. Epub 2019 Nov 21.
• Ludmer JA, Gonzalez A, Kennedy J, Masellis M, Meinz P, Atkinson L. Association between maternal childhood maltreatment and mother-infant attachment disorganization: Moderation by maternal oxytocin receptor gene and cortisol secretion. Horm Behav. 2018 Jun;102:23-33. doi: 10.1016/j.yhbeh.2018.04.006. Epub 2018 Apr 24.
• Harlow, H. F., & Zimmermann, R. R. (1958). The development of affectional responses in infant monkeys. Proceedings of the American Philosophical Society, 102(5), 501-509.
• Bell AF, Carter CS, Steer CD, Golding J, Davis JM, Steffen AD, Rubin LH, Lillard TS, Gregory SP, Harris JC, Connelly JJ. Interaction between oxytocin receptor DNA methylation and genotype is associated with risk of postpartum depression in women without depression in pregnancy. Front Genet. 2015 Jul 21;6:243. doi: 10.3389/fgene.2015.00243. eCollection 2015.
• Reiner I, Van IJzendoorn MH, Bakermans-Kranenburg MJ, Bleich S, Beutel M, Frieling H. Methylation of the oxytocin receptor gene in clinically depressed patients compared to controls: The role of OXTR rs53576 genotype. J Psychiatr Res. 2015 Jun;65:9-15. doi: 10.1016/j.jpsychires.2015.03.012. Epub 2015 Mar 24.
• Bergman Y, Cedar H. DNA methylation dynamics in health and disease. Nat Struct Mol Biol. 2013 Mar;20(3):274-81. doi: 10.1038/nsmb.2518. Erratum In: Nat Struct Mol Biol. 2013 Oct;20(10):1236.
• Aronica L, Levine AJ, Brennan K, Mi J, Gardner C, Haile RW, Hitchins MP. A systematic review of studies of DNA methylation in the context of a weight loss intervention. Epigenomics. 2017 May;9(5):769-787. doi: 10.2217/epi-2016-0182.
• Yaholkoski, A., Hurl, K., & Theule, J. (2016). Efficacy of the circle of security intervention: a meta-analysis. Journal of Infant, Child, and Adolescent Psychotherapy, 15(2), 95-103.
• Huber A, McMahon CA, Sweller N. EFFICACY OF THE 20-WEEK CIRCLE OF SECURITY INTERVENTION: CHANGES IN CAREGIVER REFLECTIVE FUNCTIONING, REPRESENTATIONS, AND CHILD ATTACHMENT IN AN AUSTRALIAN CLINICAL SAMPLE. Infant Ment Health J. 2015 Nov-Dec;36(6):556-74. doi: 10.1002/imhj.21540. Epub 2015 Nov 9.

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2023
• Primary Completion (Estimated): April 1, 2035
• Study Completion (Estimated): June 1, 2035

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 21-2593

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No