AzTrials
AzTrials

Postpartum DepressionNCT05772897

Parenting Skills Group for Mothers With Postpartum Depression

A study testing Circle of Security Parenting program in people with Postpartum Depression, run by University of Colorado, Denver at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Postpartum Depression
What is being tested?
Circle of Security Parenting program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
750 participants
Where
1 siteUnited States
Study dates
3 Aug 2023to 1 Jun 2035
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sunny Stophaeros, MS contact

9253392971

sunny.stophaeros@ucdenver.edu

Caroline R Harrison, MPH contact

caroline.harrison@cuanschutz.edu

United States1 site, 1 recruiting

  • University of Colorado Denver

    Denver, Colorado, 80204

    Sunny Stophaeros, MS, 925-339-2971, sunny.stophaeros@ucdenver.edu

    Caroline R Harrison, MPH, 2028129299, caroline.harrison@cuanschutz.edu

    Recruiting

Other trials in United States

About this study

Official title: 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?
Read more

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.

Read the 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.

Being tested
Circle of Security Parenting program
Medical subject headings
Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Circle of Security Parenting programBehavioural

    Also called COSP

    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.

Study groups in NCT05772897
Study groupRoleWhat they receive
Circle of Security Parenting (COSP) groupExperimentalThis 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.
Receives: Behavioral: Circle of Security Parenting program
Waitlist Control GroupNo interventionThis 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in methylation of OXTR receptor gene rs53576

    Buccal swabs from mother and infant

    Measured: Time1 (baseline), Time4 (1 week post-intervention), Time5 (6 months post-intervention), Time6 (12 months post-intervention) Time7 (average 4.5 years post-intervention)

  2. 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.

    Measured: 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)

  3. 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.

    Measured: 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)

  4. 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.

    Measured: 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 (7)

  1. 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.

    Measured: 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)

  2. 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.

    Measured: Time1 (baseline), Time5 (6 months post-intervention), Time6 (12 months post-intervention)

  3. 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.

    Measured: Time1 (baseline), Time2 (1 week pre-intervention), Time4 (1 week post-intervention), Time5 (6 months post-intervention), Time6 (12 months post-intervention)

  4. 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).

    Measured: 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)

  5. 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.

    Measured: Time1 (baseline), Time5 (6 months post-intervention), Time6 (12 months post-intervention), Time7 (average 4.5 years post-intervention)

  6. 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.

    Measured: Time7 (average 4.5 years post-intervention)

  7. 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.

    Measured: Time7 (average 4.5 years post-intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2023
  2. Study start3 Aug 2023
  3. Primary completion1 Apr 2035 (estimated)
  4. Study completion1 Jun 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
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)
Enrolment
750 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05772897
Sponsor's protocol ID
21-2593
Status last verified
Nov 2023
First submitted
8 Feb 2023
Last updated
30 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 9440297

  • 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.

    PubMed 10563730

  • 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.

    PubMed 15115062

  • Muzik M, Borovska S. Perinatal depression: implications for child mental health. Ment Health Fam Med. 2010 Dec;7(4):239-47.

    PubMed 22477948

  • 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.

    PubMed 31035856

  • 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.

    PubMed 26343292

  • 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.

    PubMed 22201148

Questions about this trial

What is this clinical trial studying?

A study testing Circle of Security Parenting program in people with Postpartum Depression, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sunny Stophaeros, MS (9253392971, sunny.stophaeros@ucdenver.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in methylation of OXTR receptor gene rs53576 (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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05772897, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in