Effects of Attachment-Focused Parenting Intervention on Postpartum Depression and Biological Markers of Stress in Mothers and Their Infants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postpartum Depression
- Sponsor
- University of Colorado, Denver
- Enrollment
- 750
- Locations
- 1
- Primary Endpoint
- Changes Postpartum Depression Screening Scale (PDSS) Score
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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 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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Changes Postpartum Depression Screening Scale (PDSS) Score
Time Frame: 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)
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.
Changes in Beck Depression Inventory, Second Edition (BDI-II) Score
Time Frame: 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)
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.
Changes in Dyadic Adjustment Scale (DAS) Score
Time Frame: 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)
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.
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)
Buccal swabs from mother and infant
Secondary Outcomes
- Changes in Maternal Postnatal Attachment Scale (MPAS) Score(Time1 (baseline), Time2 (1 week pre-intervention), Time4 (1 week post-intervention), Time5 (6 months post-intervention), Time6 (12 months post-intervention))
- Changes in Carey Infant Temperament Questionnaire (ITQ) Score(Time1 (baseline), Time5 (6 months post-intervention), Time6 (12 months post-intervention), Time7 (average 4.5 years post-intervention))
- Inventory of Callous-Unemotional Traits (ICU) Score(Time7 (average 4.5 years post-intervention))
- Changes in Denver Maternal Stress Assessment Score(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))
- Changes in MacArthur Short Form Vocabulary Checklist Score (child)(Time1 (baseline), Time5 (6 months post-intervention), Time6 (12 months post-intervention))
- Empathy & Theory of Mind Scale (EToMS) Score(Time7 (average 4.5 years post-intervention))
- Changes in The Multidimensional Scale of Perceived Social Support (MSPSS) Score(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))