Clinical trial NCT05772897: 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
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Depression
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 750
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in methylation of OXTR receptor gene rs53576
timeFrame: Time1 (baseline), Time4 (1 week post-intervention), Time5 (6 months post-intervention), Time6 (12 months post-intervention) Time7 (average 4.5 years post-intervention)
measure: Changes in Beck Depression Inventory, Second Edition (BDI-II) Score
timeFrame: 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)
measure: Changes Postpartum Depression Screening Scale (PDSS) Score
timeFrame: 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)
measure: Changes in Dyadic Adjustment Scale (DAS) Score
timeFrame: 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:
measure: Changes in Denver Maternal Stress Assessment Score
timeFrame: 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)
measure: Changes in MacArthur Short Form Vocabulary Checklist Score (child)
timeFrame: Time1 (baseline), Time5 (6 months post-intervention), Time6 (12 months post-intervention)
measure: Changes in Maternal Postnatal Attachment Scale (MPAS) Score
timeFrame: Time1 (baseline), Time2 (1 week pre-intervention), Time4 (1 week post-intervention), Time5 (6 months post-intervention), Time6 (12 months post-intervention)
measure: Changes in The Multidimensional Scale of Perceived Social Support (MSPSS) Score
timeFrame: 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)
measure: Changes in Carey Infant Temperament Questionnaire (ITQ) Score
timeFrame: Time1 (baseline), Time5 (6 months post-intervention), Time6 (12 months post-intervention), Time7 (average 4.5 years post-intervention)
measure: Empathy & Theory of Mind Scale (EToMS) Score
timeFrame: Time7 (average 4.5 years post-intervention)
measure: Inventory of Callous-Unemotional Traits (ICU) Score
timeFrame: Time7 (average 4.5 years post-intervention)
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: sunny.stophaeros@ucdenver.edu
name: Sunny Stophaeros, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Taylor, S. E. (2010). Health psychology. Oxford University Press.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Muzik M, Borovska S. Perinatal depression: implications for child mental health. Ment Health Fam Med. 2010 Dec;7(4):239-47.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.