Parenting Skills Group for Postpartum Depression

Overseen By Caroline Harrison, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Bipolar, Schizophrenia, Personality disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

750 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the Circle of Security Parenting (COSP) program can assist mothers with postpartum depression. Researchers aim to determine if this program can improve depression symptoms, mother-infant bonding, and infant social behavior. Participants will attend an 8-week online course, complete questionnaires, and provide cheek swabs for themselves and their infants to check for biological changes. The study seeks mothers with infants aged 3-14 months, regardless of whether they are experiencing depression. As an unphased trial, it offers a unique opportunity to contribute to understanding how parenting programs can support mental health and bonding.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are experiencing active depression and not already receiving treatment, you will be referred for professional care before joining the study.

What prior data suggests that the Circle of Security Parenting program is safe for mothers with postpartum depression?

Research has shown that the Circle of Security Parenting (COSP) program is generally safe and well-received. Caregivers who participated in the COSP program reported improved relationships with their children. Additionally, the children involved exhibited fewer emotional and behavioral problems. Studies found no major negative effects, suggesting the program is safe for participants.

The COSP program is a popular parenting approach designed to strengthen the parent-child connection. By focusing on teaching and support rather than medication, it presents fewer risks. Participants often find the program beneficial for both themselves and their children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Circle of Security Parenting (COSP) program for postpartum depression because it offers a unique approach to treatment by focusing on enhancing parenting skills and strengthening the parent-child bond. Unlike traditional treatments like medication or individual therapy, COSP is delivered remotely through group sessions via Zoom, making it accessible for new mothers who might struggle with time and mobility constraints. This method not only addresses postpartum depression but also supports the developmental needs of the child, providing a dual benefit that sets it apart from standard care options.

What evidence suggests that the Circle of Security Parenting program is effective for postpartum depression?

Research has shown that the Circle of Security Parenting (COSP) program, which participants in this trial may receive, can help mothers with postpartum depression improve their parenting skills. Studies have found that COSP makes mothers more responsive to their baby's needs and strengthens their bond. In past research, mothers who participated in COSP reported better mental health and a stronger connection with their infants. Additionally, the program has been linked to positive changes in children's social behavior. These findings suggest that COSP could be a helpful tool for mothers dealing with postpartum depression. ^{1 2 3 6 7}

Who Is on the Research Team?

Sunny Stophaeros, MS

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

This trial is for mothers aged 18-50 with infants 3-14 months old who are experiencing postpartum depression. It's also open to non-depressed control mothers. Participants should not be under current treatment for depression but will be referred if needed. Infants with major medical issues or mothers with severe psychopathology cannot join.

Inclusion Criteria

I am a mother with untreated depression seeking help.

Mothers who are experiencing symptoms of depression and mothers who are not experiencing symptoms of depression (non-depressed controls) are encouraged to participate.

I am a mother aged 18-50 with an infant aged 3-14 months.

Exclusion Criteria

Mothers with severe psychopathology (such as bipolar disorder, schizophrenia, personality disorders, among others)

My infant has major health issues that could affect my participation in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Intervention Assessment

Participants complete baseline assessments including buccal swabs and questionnaires

1 week

Remote assessments

Treatment

Participants engage in an 8-week Circle of Security Parenting (COSP) program delivered via Zoom

8 weeks

Weekly remote sessions

Post-Intervention Assessment

Participants complete post-intervention assessments including buccal swabs and questionnaires

1 week

Remote assessments

Follow-up

Participants are monitored for changes in depression, attachment, and social behavior

12 months

Remote assessments at 6 and 12 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Circle of Security Parenting program

Trial Overview The study tests the Circle of Security Parenting program (COSP) delivered over Zoom for 8 weeks, focusing on its impact on maternal and infant gene changes, symptoms of depression, attachment style, mother-infant relationship quality, and social behavior in infants.

How Is the Trial Designed?

Group I: Circle of Security Parenting (COSP) group Experimental Treatment 1 Intervention

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.

Group II: Waitlist Control Group Active Control 1 Intervention

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.

Circle of Security Parenting program is already approved in United States, European Union for the following indications:

Approved in United States as Circle of Security Parenting for:

• Postpartum depression
• Attachment issues in mother-infant dyads

Approved in European Union as Circle of Security Parenting for:

• Postpartum depression
• Attachment issues in mother-infant dyads

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

A study involving 701 women at high risk for postpartum depression found that those receiving telephone-based peer support reported high satisfaction levels (80.5%) and positive relationship qualities such as trust and acceptance.

The peer support provided emotional, informational, and appraisal support, indicating that this approach can be an effective preventive strategy against postpartum depression, especially when tailored to the needs of the mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum depression peer support: maternal perceptions from a randomized controlled trial. Dennis, CL.[2022]

Postpartum depression (PPD) significantly impacts the emotional and cognitive development of children, highlighting the importance of addressing maternal mental health.

Mothers with PPD tend to replicate the patterns of parental care they experienced in their own childhood, suggesting that early interventions could help break this cycle and improve outcomes for both mothers and their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Parental care and post partum depression: a case report]. Aceti, F., Carluccio, GM., Meuti, V., et al.[2012]

Mothers with postpartum depression who participated in the Circle of Security (COS) intervention reported significantly higher satisfaction regarding their relationship with their child compared to those receiving standard treatment (TAU).

Both COS and TAU groups expressed greater satisfaction with the process quality of treatment (like therapist competence and relationship quality) than with the actual outcomes, highlighting the importance of the therapeutic process in enhancing maternal satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment Satisfaction of Mothers with Postpartum Depression Concerning Circle of Security Intervention]. Moschner, SL., Achtergarde, S., Ramsauer, B.[2019]

The Circle of Security-Intensive (COS-I) intervention did not show significant differences in infant attachment or maternal sensitivity compared to treatment-as-usual (TAU) in a study involving 72 mother-infant dyads.

However, mothers with unresolved attachment histories showed greater improvements in sensitivity when participating in COS-I, suggesting that this intervention may be particularly beneficial for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of the Circle of Security-Intensive intervention for mothers with postpartum depression: maternal unresolved attachment moderates changes in sensitivity. Ramsauer, B., Mühlhan, C., Lotzin, A., et al.[2021]

The study evaluates the effectiveness of the Circle of Security Parenting (COS-P) intervention in a non-randomized controlled setting, involving caregivers of children aged 6 years and under facing early parenting challenges, which addresses a significant evidence gap in existing research.

By assessing changes in caregiving attitudes and caregiver depression symptoms, this study aims to provide insights into the effectiveness of COS-P and identify which demographic factors may influence its success, making it one of the first controlled evaluations of this intervention in Australia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing the Evidence Gap: Protocol for an Effectiveness Study of Circle of Security Parenting, an Attachment-Based Intervention. Maxwell, AM., McMahon, C., Huber, A., et al.[2021]

The study aims to conduct a large randomized controlled trial with 369 participants to evaluate the effectiveness of the Circle of Security-Parenting (COS-P) program in reducing perinatal mental health symptoms among birthing parents with severe difficulties, compared to standard treatment.

If successful, this trial could establish COS-P as a widely applicable intervention within NHS services, potentially improving mental health outcomes and parenting skills for many families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The COSI trial: a study protocol for a multi-centre, randomised controlled trial to explore the clinical and cost-effectiveness of the Circle of Security-Parenting Intervention in community perinatal mental health services in England. Rosan, C., Dijk, KA., Darwin, Z., et al.[2023]

Couples coping with maternal postpartum depression (PPD) navigate three key phases: Dismissal, where they normalize the situation; Acknowledgment, where they express concerns and seek help; and Accommodation, where they experiment to meet the mother's needs.

The study highlights the importance of supporting the entire family, including fathers, during maternal PPD, as fathers also experience increased stress while providing support to mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Couples' Experiences of Maternal Postpartum Depression. O'Brien, AJ., Chesla, CA., Humphreys, JC.[2020]

Citations

1. samhsa.gov samhsa.gov/

Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8594052/

Protocol for an Effectiveness Study of Circle of Security ... Background: Parenting interventions informed by attachment theory are an increasingly popular choice for clinical services that work with parents of babies ...

3. thelancet.com thelancet.com/journals/lanpsy/article/PIIS2215-0366(25)00263-9/fulltext

Clinical effectiveness of the Circle of Security-Parenting ... Perinatal mental health difficulties are common and, if untreated, are associated with long-term adverse child outcomes.

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07194-3

The COSI trial: a study protocol for a multi-centre, randomised ... Perinatal mental health difficulties affect up to 27% of birthing parents during pregnancy and the first postnatal year, and if untreated ...

5. withpower.com withpower.com/trial/parenting-skills-group-for-postpartum-depression-49d34

Parenting Skills Group for Postpartum Depression Additionally, the Circle of Security-Intensive intervention helped mothers with unresolved attachment issues improve their sensitivity towards their infants.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190740919314586

Effects of the 'Circle of Security' group parenting program ... Foster carers who participated in COS-P reported reductions in levels of emotional and behavioural difficulties for the children in their care.

7. preventionservices.acf.hhs.gov preventionservices.acf.hhs.gov/programs/771/show

Circle of Security – Intensive™ Circle of Security – Intensive™ (COS-Intensive™) is a caregiver training and psychoeducation intervention that aims to improve caregiver-child relationships ...