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

Sponsor

Montefiore Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06042166

Collaborator

American Psychological Foundation (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Depression Postpartum Anxiety Parenting Stress Parent Child Relationships	Behavioral: Connecting and Reflecting Experience (CARE) Program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Connecting and Reflecting Experience (CARE) Program Participants will enroll in a 12-session CARE parenting group therapy.	Behavioral: Connecting and Reflecting Experience (CARE) Program 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.

Arm

Intervention/Treatment

Experimental: Connecting and Reflecting Experience (CARE) Program

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

Behavioral: Connecting and Reflecting Experience (CARE) Program

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.

Outcome Measures

Primary Outcome Measures

Change from Baseline to Post-Treatment in Postpartum Anxiety Score [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).]
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 [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).]
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 [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).]
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 [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).]
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 [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).]
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 [This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).]
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 [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).]
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 [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).]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts 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)