Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552832
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-06
Brief Title:
CAVEAT An Open-Trial Feasibility Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinician-Assisted Video Feedback Exposure-Approach Therapy CAVEAT An Open-Trial of a Brief Psychotherapy for Traumatized Mothers and Their Young Children
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAVEAT-OT
Brief Summary:
This is an open-clinical trial to study the feasibility of a brief manualized psychotherapy for mothers interpersonal violence-related posttraumatic stress disorder PTSD and their very young children ages 1-3 years entitled Clinician-Assisted Videofeedback Exposure Approach Therapy CAVEAT This project to be conducted with referred mothers and children to an academic medical center ambulatory care setting intends to pilot along with the manualized intervention pre- and post-intervention measures for up to 10 dyads over 2 years
Detailed Description:
This study is based on empirical research findings that demonstrate psychobiological dysregulation at multiple levels among violently traumatized mothers of infants and young children A number of studies over the past decades have described the deleterious effects this dysregulation can have on the mother-infant relationship during formative development of self-regulation of emotion arousal and aggression in the young child Out of this research and clinical experience the principal investigator PI developed The Clinician-Assisted Videofeedback Exposure Session CAVES originally as an experimental evaluation technique and test-intervention Schechter 2003 The theoretical premise evidence-base and signature features of the CAVES became the foundation for a new brief psychotherapeutic model for traumatized parents and their very young children ages 1 to 4 Clinician-Assisted Videofeedback Exposure Approach Therapy CAVEAT Two published studies involving both a clinically-referred and non-referred sample of mothers and children have shown a significant reduction in the degree of negativity and age-inappropriateness of maternal attributions towards her child Schechter et al 2006 Schechter et al 2015 The latter is important as maternal attributions represent keys to maternal mental representations that in turn mark the mothers transference to her own child Lieberman 1999 Lacking thus far however has been a study to examine the sustainability of these changes in maternal perception and whether change in maternal perception translates into measurable change in mother-child interactive behaviour including increased maternal sensitivity reflective functioning and reduction in child symptoms Since 2008 the PI has closely collaborated on a number of projects with the co-PI who has extensive experience in psychotherapy research having worked with pioneers Bertrand Cramer Daniel Stern in Switzerland Cramer et al 1990 and Susan McDonough in the US Rusconi Serpa Sancho Rossignol McDonough 2009 In 2012 the PI co-PI and colleagues began to conceptualize a manualized brief-psychotherapy that would be most likely to sustain changes over time CAVEAT Sessions are divided into 4 modules 1 Evaluation diagnostic formulation and identification of objectives and triggers of maternal posttraumatic stress in the parent-child relationship 5 sessions 2 Differentiation between past and present relationships 4 sessions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None