Parenting Skills Group for Postpartum Depression

Overseen By Caroline R 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

Trial Summary

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 data supports the effectiveness of the treatment Circle of Security Parenting program for postpartum depression?

Research shows that mothers with postpartum depression who participated in the Circle of Security intervention reported higher satisfaction with their child's progress compared to standard treatment. Additionally, the Circle of Security-Intensive intervention helped mothers with unresolved attachment issues improve their sensitivity towards their infants. ^{1 2 3 4 5}

How is the Circle of Security Parenting treatment different from other treatments for postpartum depression?

The Circle of Security Parenting (COSP) treatment is unique because it focuses on improving parenting skills and the parent-infant relationship through a brief, weekly group program, which is different from typical individual therapy or medication approaches. It aims to enhance parenting sensitivity and secure attachment between mother and child, which is particularly important for mothers with postpartum depression. ^{2 3 5 6 7}

What is the purpose of this trial?

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.

Research Team

Sunny Stophaeros, MS

Principal Investigator

[e-mail]

Eligibility Criteria

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 aged 18-50 with an infant aged 3-14 months.

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 with untreated depression seeking help.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Treatment Satisfaction of Mothers with Postpartum Depression Concerning Circle of Security Intervention]. [2019]

2. England 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. [2023]

3. England 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. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Addressing the Evidence Gap: Protocol for an Effectiveness Study of Circle of Security Parenting, an Attachment-Based Intervention. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Couples' Experiences of Maternal Postpartum Depression. [2020]

6. England pubmed.ncbi.nlm.nih.gov

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

7. Italy pubmed.ncbi.nlm.nih.gov

[Parental care and post partum depression: a case report]. [2012]