CAVEAT: An Open-Trial Feasibility Study (CAVEAT-OT)

Clinician-Assisted Video Feedback Exposure-Approach Therapy (CAVEAT): An Open-Trial of a Brief Psychotherapy for Traumatized Mothers and Their Young Children

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.

Study Overview

• Status: Recruiting
• Conditions: PTSD; Parent-Child Relations; Dissociation
• Intervention / Treatment: Other: CAVEAT

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 mother's 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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel S Schechter, MD; Phone Number: +41213148558; Email: daniel.schechter@chuv.ch
• Study Contact Backup: Name: Ryan J Murray, PhD; Phone Number: +41213147485; Email: ryan.murray@chuv.ch

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1004
      • Recruiting
      • Lausanne University Hospital, Child & Adolescent Psychiatry Service
      • Contact: Daniel S Schechter, MD; Phone Number: +41213148558; Email: daniel.schechter@chuv.ch
      • Contact: Ryan J Murray, PhD; Phone Number: +41213147485; Email: ryan.murray@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• French-speaking, biological child living with mother

Exclusion Criteria:

• Physical and/or mental handicap that can interfere with participation in play and measures, active psychotic illness or substance abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAVEAT; Clinician-Assisted Videofeedback Exposure	Other: CAVEAT; Brief manualized parent-child psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenting Stress Index- Short Form	Self-report questionnaire	Pre- and Post-Intervention within 6 weeks after last session
Maternal Attributions Rating Scale	Clinician-rated measure	Pre- and Post-Intervention within 6 weeks after last session
Brief Infant-Toddler Social Emotional Assessment	Maternal-report questionnaire	Pre- and Post-Intervention within 6 weeks after last session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Satisfaction Questionnaire	Maternal and Therapist completed questionnaire	Post-Intervention within 6 weeks after last session

Collaborators and Investigators

• Sponsor: University of Lausanne Hospitals
• Collaborators: Sandra Rusconi Serpa

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Parenting; Interpersonal Violence; Mentalization; Brief Psychotherapy; Infant Mental Health; Videofeedback
• Additional Relevant MeSH Terms: Mental Disorders; Dissociative Disorders
• Other Study ID Numbers: CHUV-SUPEA-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No