Clinical trial NCT06042166: A Postpartum Adaptation Study of the Connecting and Reflecting Experience Parenting Program
Official title: A Postpartum Adaptation Study of the Connecting and Reflecting Experience Parenting Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: American Psychological Foundation
First posted: 2023-09-18
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change from Baseline to Post-Treatment in Postpartum Anxiety Score
timeFrame: 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).
measure: Change from Baseline to Post-Treatment in Postpartum Depression Score
timeFrame: 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).
measure: Change from Baseline to Post-Treatment in Parenting Stress Score
timeFrame: 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).
measure: Change from Baseline to Post-Treatment in Parental Reflective Functioning
timeFrame: 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).
measure: Change from Baseline to Post-Treatment in Parent-Infant Bonding
timeFrame: 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).
measure: Post-treatment rating of treatment acceptability and feasibility
timeFrame: This survey will be administered at post-treatment (i.e., after completion of Session 12, approximately 15 weeks after baseline measurement).
measure: Change from Session 1 to Session 12 in Therapeutic Group Processes
timeFrame: 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 outcomes:
measure: Change from Baseline to Post-Treatment in Infant Temperament
timeFrame: 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).
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center/Albert Einstein College of Medicine
name: Amanda Zayde, Psy.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
citation: Beck, AT, Steer, RA. Beck Anxiety Inventory Manual. San Antonio, TX: Psychological Corporation. 1993.
citation: Abidin, R. R. (2012). Parenting Stress Index (4th ed.). Lutz, FL: PAR.
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.
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.