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A Postpartum Adaptation Study of the Connecting and Reflecting Experience Parenting Program (PMAD-CARE)

Primary Purpose

Postpartum Depression, Postpartum Anxiety, Parenting Stress

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Connecting and Reflecting Experience (CARE) Program
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression focused on measuring postpartum depression, group therapy, parenting stress, short-term therapy, parenting support, postpartum anxiety, perinatal mood and anxiety disorders, mentalizing, parental reflective functioning, attachment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Birthing parent (of any gender) of an infant age 3-12 months old at baseline Receiving postpartum OB/GYN or mental health services at Montefiore Medical Center Experienced or currently experiencing moderate to high levels of depression and/or anxiety symptoms in the postpartum period English-speaking Exclusion Criteria: Prior participation in a Connecting and Reflecting Experience (CARE) group at any time Participation in another parenting-focused group during the current postpartum period Current episode of psychosis or mania Psychiatric, neurocognitive, or substance use related difficulties necessitating a higher level of care than outpatient support (e.g., current inpatient treatment) or that would impede group participation (e.g., severe cognitive impairment)

Sites / Locations

  • Montefiore Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Connecting and Reflecting Experience (CARE) Program

Arm Description

Participants will enroll in a 12-session CARE parenting group therapy.

Outcomes

Primary Outcome Measures

Change from Baseline to Post-Treatment in Postpartum Anxiety Score
Change in postpartum anxiety will be measured using the total score on a self-reported questionnaire: the 21-item Beck Anxiety Inventory (BAI; Beck et al, 1988). Total scores range from 0 to 63, with higher scores indicating higher anxiety symptoms.
Change from Baseline to Post-Treatment in Postpartum Depression Score
Change in postpartum depression will be measured using the total score on a self-reported questionnaire: the Edinburgh Postnatal Depression Scale (EPDS; Cox, Holden, & Sagovsky, 1987). Total scores range from 0 to 30, with higher scores indicating higher depression symptoms.
Change from Baseline to Post-Treatment in Parenting Stress Score
Change in parenting stress will be measured using the total score on a self-reported questionnaire: the 36-item Parenting Stress Index, Short-Form (PSI-SF; Abidin, 2012). Total scores range from 36 to 180. Raw scores can be converted to percentile based on a normed sample. Higher raw and percentile scores indicate higher levels of parenting stress. Scores falling between the 16th and 84th percentiles are considered within the normal range of parenting stress, scores between the 85th and 89th percentiles are considered high, and scores at the 90th percentile and above are considered in the clinically significant range.
Change from Baseline to Post-Treatment in Parental Reflective Functioning
Change in parental reflective functioning will be measured using subscale scores on a self-reported questionnaire: the 18-item Parental Reflective Functioning Questionnaire (PRFQ; Luyten et al., 2017). The PRFQ has three subscales, each of which has a score range from 6 to 42. Though threshold scores have not been established for the PRFQ, "adaptive" subscale scores would be in the mid-range for Certainty about Mental States, low range for Prementalizing Modes, and high range for Interest and Curiosity about Mental States.
Change from Baseline to Post-Treatment in Parent-Infant Bonding
Change in parent-infant bonding will be measured using subscale scores on a self-reported questionnaire: the 25-item Postpartum Bonding Questionnaire (PBQ; Brockington et al., 2001). The PBQ has 4 subscales. Scale 1 (12 items) has a score range from 0 to 60; scores above 12 are considered "high" in impaired bonding. Scale 2 (7 items) has a score range from 0 to 35; scores above 17 are considered "high" in relational rejection/anger. Scale 3 (4 items) has a score range from 0 to 20; scores above 10 are considered "high" in anxiety about infant care. Scale 4 (2 items) has a range from 0 to 10; scores above 3 are considered "high" in aggression risk.
Post-treatment rating of treatment acceptability and feasibility
Participants will complete a brief self-reported survey developed for this study to assess their perceptions of treatment acceptability and feasibility. Participants will rate their sense of satisfaction, enjoyment, helpfulness, and comfort with the CARE group program on a scale from 0 to 10, where higher scores indicate greater treatment acceptability. Participants will also rate how challenging aspects of group were (i.e., attendance and emotional content) from 0 to 10, where higher scores indicate lower program feasibility/greater challenge. Participants will also be asked to provide qualitative feedback regarding their impressions of the program.
Change from Session 1 to Session 12 in Therapeutic Group Processes
Change in therapeutic group processes will be measured using subscales on a self-reported questionnaire: the revised Therapeutic Factors Inventory-19 item version (TFI-19; Joyce et al., 2011). Each item is scored from 1 to 7. Subscale scores are generated as an average/mean of item ratings. Higher subscale scores indicate greater perceptions of indicated therapeutic factors within their CARE group: Instillation of Hope (4 items), Secure Emotional Expression (7 items), Awareness of Relational Impact (5 items), and Social Learning (3 items).

Secondary Outcome Measures

Change from Baseline to Post-Treatment in Infant Temperament
Change in infant temperament will be measured using a parent-reported questionnaire: the 37-item Infant Behavior Questionnaire, Revised, Very Short Form (IBQ-VSF; Putnam et al., 2014). The IBQ-VSF has 3 subscales for which mean scores ranging from 1 to 7 are generated. The Surgency subscale has 13 items; higher scores indicate greater infant emotional surgency. The Negative Affect subscale has 12 items; higher scores indicate greater infant negative affect. The Effortful Control subscale has 12 items; higher scores indicate greater infant effortful control.

Full Information

First Posted
September 6, 2023
Last Updated
October 3, 2023
Sponsor
Montefiore Medical Center
Collaborators
American Psychological Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT06042166
Brief Title
A Postpartum Adaptation Study of the Connecting and Reflecting Experience Parenting Program
Acronym
PMAD-CARE
Official Title
A Postpartum Adaptation Study of the Connecting and Reflecting Experience Parenting Program
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
Collaborators
American Psychological Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Experiencing postpartum mood and/or anxiety disorders (like postpartum depression; PMADs) can make parenting challenging, but group therapy may help both these parents and their babies. This study will test whether postpartum parents with PMADs find a 12-session parenting group therapy to be likable, doable, and helpful for mental health, parenting stress, and relationship with their infant. The therapy that is being tested is called the Connecting and Reflecting Experience (CARE) parenting program, which has not yet been used specifically with postpartum parents with PMADs, but has been found to be appealing and helpful among parents/caregivers of older children with mental health conditions. CARE focuses on parents' ability to consider how their own and their children's thoughts, feelings, intentions, and other mental states shape behavior and parent-child relationships. Participants in the study will be asked to fill out surveys before, during, and after participating in the group therapy. Adults may be eligible to participate in the study if they gave birth to an infant who is now 3 to 12 months old, are receiving postpartum medical and/or mental health care at Montefiore Medical Center, and have experienced postpartum depression and/or anxiety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression, Postpartum Anxiety, Parenting Stress, Parent Child Relationships
Keywords
postpartum depression, group therapy, parenting stress, short-term therapy, parenting support, postpartum anxiety, perinatal mood and anxiety disorders, mentalizing, parental reflective functioning, attachment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Connecting and Reflecting Experience (CARE) Program
Arm Type
Experimental
Arm Description
Participants will enroll in a 12-session CARE parenting group therapy.
Intervention Type
Behavioral
Intervention Name(s)
Connecting and Reflecting Experience (CARE) Program
Intervention Description
The intervention consists of a 12-session mentalizing-focused parenting group, which will involve weekly one-hour telehealth therapy sessions with up to 7 postpartum parents per group and 1 to 2 facilitators. CARE is a therapy focused on parents' reflective capacity, or the ability to consider how our own and our children's thoughts, feelings, intentions, and other mental states shape behavior and parent-child relationships.
Primary Outcome Measure Information:
Title
Change from Baseline to Post-Treatment in Postpartum Anxiety Score
Description
Change in postpartum anxiety will be measured using the total score on a self-reported questionnaire: the 21-item Beck Anxiety Inventory (BAI; Beck et al, 1988). Total scores range from 0 to 63, with higher scores indicating higher anxiety symptoms.
Time Frame
The BAI will be administered at baseline (approximately 0-2 weeks pre-treatment) and at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement).
Title
Change from Baseline to Post-Treatment in Postpartum Depression Score
Description
Change in postpartum depression will be measured using the total score on a self-reported questionnaire: the Edinburgh Postnatal Depression Scale (EPDS; Cox, Holden, & Sagovsky, 1987). Total scores range from 0 to 30, with higher scores indicating higher depression symptoms.
Time Frame
The EPDS will be administered at baseline (approximately 0-2 weeks pre-treatment) and at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement).
Title
Change from Baseline to Post-Treatment in Parenting Stress Score
Description
Change in parenting stress will be measured using the total score on a self-reported questionnaire: the 36-item Parenting Stress Index, Short-Form (PSI-SF; Abidin, 2012). Total scores range from 36 to 180. Raw scores can be converted to percentile based on a normed sample. Higher raw and percentile scores indicate higher levels of parenting stress. Scores falling between the 16th and 84th percentiles are considered within the normal range of parenting stress, scores between the 85th and 89th percentiles are considered high, and scores at the 90th percentile and above are considered in the clinically significant range.
Time Frame
The PSI-SF will be administered at baseline (approximately 0-2 weeks pre-treatment) and at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement).
Title
Change from Baseline to Post-Treatment in Parental Reflective Functioning
Description
Change in parental reflective functioning will be measured using subscale scores on a self-reported questionnaire: the 18-item Parental Reflective Functioning Questionnaire (PRFQ; Luyten et al., 2017). The PRFQ has three subscales, each of which has a score range from 6 to 42. Though threshold scores have not been established for the PRFQ, "adaptive" subscale scores would be in the mid-range for Certainty about Mental States, low range for Prementalizing Modes, and high range for Interest and Curiosity about Mental States.
Time Frame
The PRFQ will be administered at baseline (approximately 0-2 weeks pre-treatment) and at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement).
Title
Change from Baseline to Post-Treatment in Parent-Infant Bonding
Description
Change in parent-infant bonding will be measured using subscale scores on a self-reported questionnaire: the 25-item Postpartum Bonding Questionnaire (PBQ; Brockington et al., 2001). The PBQ has 4 subscales. Scale 1 (12 items) has a score range from 0 to 60; scores above 12 are considered "high" in impaired bonding. Scale 2 (7 items) has a score range from 0 to 35; scores above 17 are considered "high" in relational rejection/anger. Scale 3 (4 items) has a score range from 0 to 20; scores above 10 are considered "high" in anxiety about infant care. Scale 4 (2 items) has a range from 0 to 10; scores above 3 are considered "high" in aggression risk.
Time Frame
The PBQ will be administered at baseline (approximately 0-2 weeks pre-treatment) and at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement).
Title
Post-treatment rating of treatment acceptability and feasibility
Description
Participants will complete a brief self-reported survey developed for this study to assess their perceptions of treatment acceptability and feasibility. Participants will rate their sense of satisfaction, enjoyment, helpfulness, and comfort with the CARE group program on a scale from 0 to 10, where higher scores indicate greater treatment acceptability. Participants will also rate how challenging aspects of group were (i.e., attendance and emotional content) from 0 to 10, where higher scores indicate lower program feasibility/greater challenge. Participants will also be asked to provide qualitative feedback regarding their impressions of the program.
Time Frame
This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).
Title
Change from Session 1 to Session 12 in Therapeutic Group Processes
Description
Change in therapeutic group processes will be measured using subscales on a self-reported questionnaire: the revised Therapeutic Factors Inventory-19 item version (TFI-19; Joyce et al., 2011). Each item is scored from 1 to 7. Subscale scores are generated as an average/mean of item ratings. Higher subscale scores indicate greater perceptions of indicated therapeutic factors within their CARE group: Instillation of Hope (4 items), Secure Emotional Expression (7 items), Awareness of Relational Impact (5 items), and Social Learning (3 items).
Time Frame
The TFI-19 will be administered after participants complete Session 1 of group (approximately 0-2 weeks after baseline measurement) and again at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement).
Secondary Outcome Measure Information:
Title
Change from Baseline to Post-Treatment in Infant Temperament
Description
Change in infant temperament will be measured using a parent-reported questionnaire: the 37-item Infant Behavior Questionnaire, Revised, Very Short Form (IBQ-VSF; Putnam et al., 2014). The IBQ-VSF has 3 subscales for which mean scores ranging from 1 to 7 are generated. The Surgency subscale has 13 items; higher scores indicate greater infant emotional surgency. The Negative Affect subscale has 12 items; higher scores indicate greater infant negative affect. The Effortful Control subscale has 12 items; higher scores indicate greater infant effortful control.
Time Frame
The IBQ-VSF will be administered at baseline (approximately 0-2 weeks pre-treatment) and at post-treatment (after completion of Session 12, approximately 15 weeks after baseline measurement).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Birthing parent (of any gender) of an infant age 3-12 months old at baseline Receiving postpartum OB/GYN or mental health services at Montefiore Medical Center Experienced or currently experiencing moderate to high levels of depression and/or anxiety symptoms in the postpartum period English-speaking Exclusion Criteria: Prior participation in a Connecting and Reflecting Experience (CARE) group at any time Participation in another parenting-focused group during the current postpartum period Current episode of psychosis or mania Psychiatric, neurocognitive, or substance use related difficulties necessitating a higher level of care than outpatient support (e.g., current inpatient treatment) or that would impede group participation (e.g., severe cognitive impairment)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia J Derella, Ph.D.
Phone
718-304-7022
Email
olivia.derella@einsteinmed.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Zayde, Psy.D.
Phone
718-304-7128
Email
azayde@montefiore.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Zayde, Psy.D.
Organizational Affiliation
Montefiore Medical Center/Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10470
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivia J. Derella, Ph.D.
Phone
718-304-7022
Email
CAREprogram@montefiore.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The study is a small pilot and thus data sharing is not appropriate at this stage.
Citations:
PubMed Identifier
34525847
Citation
Zayde A, Kilbride A, Kucer A, Willis HA, Nikitiades A, Alpert J, Gabbay V. Connection During COVID-19: Pilot Study of a Telehealth Group Parenting Intervention. Am J Psychother. 2022 Jun 15;75(2):67-74. doi: 10.1176/appi.psychotherapy.20210005. Epub 2021 Sep 16.
Results Reference
background
PubMed Identifier
36862314
Citation
Zayde A, Derella OJ, Kilbride A. Safe haven in adolescence: Improving parental reflective functioning and youth attachment and mental health with the Connecting and Reflecting Experience. Infant Ment Health J. 2023 Mar;44(2):268-283. doi: 10.1002/imhj.22042. Epub 2023 Mar 2.
Results Reference
background
PubMed Identifier
32072881
Citation
Zayde A, Prout TA, Kilbride A, Kufferath-Lin T. The Connecting and Reflecting Experience (CARE): theoretical foundation and development of mentalizing-focused parenting groups. Attach Hum Dev. 2021 Jun;23(3):293-309. doi: 10.1080/14616734.2020.1729213. Epub 2020 Feb 19.
Results Reference
background
PubMed Identifier
24206185
Citation
Putnam SP, Helbig AL, Gartstein MA, Rothbart MK, Leerkes E. Development and assessment of short and very short forms of the infant behavior questionnaire-revised. J Pers Assess. 2014;96(4):445-58. doi: 10.1080/00223891.2013.841171. Epub 2013 Nov 9.
Results Reference
background
PubMed Identifier
28472162
Citation
Luyten P, Mayes LC, Nijssens L, Fonagy P. The parental reflective functioning questionnaire: Development and preliminary validation. PLoS One. 2017 May 4;12(5):e0176218. doi: 10.1371/journal.pone.0176218. eCollection 2017.
Results Reference
background
PubMed Identifier
21720793
Citation
Goodman JH, Santangelo G. Group treatment for postpartum depression: a systematic review. Arch Womens Ment Health. 2011 Aug;14(4):277-93. doi: 10.1007/s00737-011-0225-3. Epub 2011 Jul 1.
Results Reference
background
Citation
Brockington IF, Oates J, George S, Turner D, Vostanis P, Sullivan M, Loh C, Murdoch C. A screening questionnaire for mother-infant bonding disorders. Archives of Women's Mental Health. 2001; 3: 133-140.
Results Reference
background
Citation
Beck, AT, Steer, RA. Beck Anxiety Inventory Manual. San Antonio, TX: Psychological Corporation. 1993.
Results Reference
background
Citation
Abidin, R. R. (2012). Parenting Stress Index (4th ed.). Lutz, FL: PAR.
Results Reference
background
PubMed Identifier
3651732
Citation
Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
Results Reference
background
Citation
Joyce AS, MacNair-Semands R, Tasca GA, Ogrodniczuk JS. Factor structure and validity of the Therapeutic Factors Inventory-Short Form. Group Dynamics. 2011; 15(3): 201-219.
Results Reference
background

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A Postpartum Adaptation Study of the Connecting and Reflecting Experience Parenting Program

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