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

Postpartum Depression Clinical Trial

— PMAD-CARE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06042166
• Other study ID #: 2023-15124
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Montefiore Medical Center
• Contact: Olivia J Derella, Ph.D.
• Phone: 718-304-7022
• Email: olivia.derella[@]einsteinmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 21
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Parent Child Relationships
• Parenting Stress
• Postpartum Anxiety
• Postpartum Depression

Intervention

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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	American Psychological Foundation

Country where clinical trial is conducted

United States, 

References & Publications (11)

Abidin, R. R. (2012). Parenting Stress Index (4th ed.). Lutz, FL: PAR.

Beck, AT, Steer, RA. Beck Anxiety Inventory Manual. San Antonio, TX: Psychological Corporation. 1993.

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.

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. — View 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. — View 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.

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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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).
Primary	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.	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).
Primary	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.	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).
Primary	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.	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).
Primary	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.	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).
Primary	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.	This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).
Primary	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).	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	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.	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).