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Parenting Skills Group for Postpartum Depression

N/A

Recruiting

Led By Sunny Stophaeros, MS

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time7 (average 4.5 years post-intervention)

Awards & highlights

Study Summary

This trial aims to find out if an 8-week parenting program (COSP) can help improve postpartum depression, attachment style, and mother-infant relationship. Participants provide swabs and answer questionnaires, with infant development tested.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this is a psychological intervention rather than a drug trial, traditional side effects are not expected. However, discussing emotional topics during the program could potentially cause discomfort or emotional distress.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time7 (average 4.5 years post-intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time7 (average 4.5 years post-intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and time7 (average 4.5 years post-intervention) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in methylation of OXTR receptor gene rs53576

Changes Postpartum Depression Screening Scale (PDSS) Score

Changes in Beck Depression Inventory, Second Edition (BDI-II) Score

+1 more

Secondary outcome measures

Changes in Carey Infant Temperament Questionnaire (ITQ) Score

Changes in Denver Maternal Stress Assessment Score

Changes in MacArthur Short Form Vocabulary Checklist Score (child)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Circle of Security Parenting (COSP) groupExperimental Treatment1 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 GroupActive Control1 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,148,776 Total Patients Enrolled

1 Trials studying Postpartum Depression

880 Patients Enrolled for Postpartum Depression

Sunny Stophaeros, MSPrincipal Investigatorsunny.stophaeros@ucdenver.edu

Media Library

Circle of Security Parenting program Clinical Trial Eligibility Overview. Trial Name: NCT05772897 — N/A

Postpartum Depression Research Study Groups: Circle of Security Parenting (COSP) group, Waitlist Control Group

Postpartum Depression Clinical Trial 2023: Circle of Security Parenting program Highlights & Side Effects. Trial Name: NCT05772897 — N/A

Circle of Security Parenting program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05772897 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for those interested to participate in the experiment?

"Affirmative. Clinicaltrials.gov contains records indicating that this study is presently recruiting participants, with the first post being made on April 1st 2023 and most recently updated on March 6th 2023. A total of 750 individuals are expected to join from one clinical site."

Answered by AI

Might I fulfill the criteria to take part in this investigation?

"To be considered for this clinical trial, individuals must possess postpartum depression and fall between the ages of 18 to 50. In total, 750 participants are sought after by researchers."

Answered by AI

How many individuals are participating in this research project?

"Affirmative. Clinicaltrials.gov provides evidence that this research is actively recruiting, with a first posting date of April 1st 2023 and the most recent update on March 6th 2023. The study requires 750 participants from one single site."

Answered by AI

What end goal are the researchers hoping to reach with this experiment?

"The central outcome of this research endeavour, monitored at baseline (Time1), one week post-intervention (Time4), six months post-intervention (Time5), twelve months post-intervention (Time6) and four and a half years after the intervention's conclusion (on average; Time7) is Changes in Beck Depression Inventory, Second Edition Score. Other objectives include measuring changes on MacArthur Short Form Vocabulary Checklist Score for children aged 8 to 18 months old, Maternal Postnatal Attachment Scale Score which measures parent-infant attachment intensity from 1 to 5, and Multidimensional Scale of Perceived Social Support"

Answered by AI

Does this trial accommodate individuals below the age of 70?

"This clinical trial is only enrolling participants between the ages of 18 and 50. In comparison, there are 196 medical studies available for minors and 1007 trials suitable for seniors."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Parenting Skills Group for Mothers With Postpartum Depression

2023. "Parenting Skills Group for Mothers With Postpartum Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05772897.