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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
No Placebo-Only Group
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.
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.
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,810 Previous Clinical Trials
2,919,230 Total Patients Enrolled
Sunny Stophaeros, MSPrincipal Investigatorsunny.stophaeros@ucdenver.edu
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a mother aged 18-50 with an infant aged 3-14 months.My infant has major health issues that could affect my participation in the study.I am a mother with untreated depression seeking help.
Research Study Groups:
This trial has the following groups:- Group 1: Circle of Security Parenting (COSP) group
- Group 2: Waitlist Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.