Parenting Skills Group for Mothers With Postpartum Depression

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Change in methylation of OXTR receptor gene rs53576 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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)]

Вторичные конечные точки (7)

• Changes in Denver Maternal Stress Assessment Score [Срок оценки: 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) [Срок оценки: Time1 (baseline), Time5 (6 months post-intervention), Time6 (12 months post-intervention)]
• Changes in Maternal Postnatal Attachment Scale (MPAS) Score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Time7 (average 4.5 years post-intervention)]
• Inventory of Callous-Unemotional Traits (ICU) Score [Срок оценки: Time7 (average 4.5 years post-intervention)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Colorado Denver — Denver

Публикации

• 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. PMID 10360120
• 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.
• 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. PMID 15354371
• 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. PMID 21551396
• 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. PMID 17143777
• 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. PMID 18586183
• 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. PMID 9440297

Идентификаторы

NCT: NCT05772897 · 21-2593

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗