CAVEAT: An Open-Trial Feasibility Study

NCT ID: NCT06552832

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-07-31

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 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);

Conditions

Parent-Child Relations; PTSD; Dissociation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAVEAT

Clinician-Assisted Videofeedback Exposure

Group Type: EXPERIMENTAL

CAVEAT

Intervention Type: OTHER

Brief manualized parent-child psychotherapy

Interventions

CAVEAT

Brief manualized parent-child psychotherapy

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sandra Rusconi Serpa

UNKNOWN

Sponsor Role: collaborator

University of Lausanne Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Daniel Schechter

Associate Professor and Senior Consultant in Child & Adolescent Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lausanne University Hospital, Child & Adolescent Psychiatry Service

Lausanne, Canton of Vaud, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Daniel S Schechter, MD

Role: CONTACT

daniel.schechter@chuv.ch

+41213148558

Ryan J Murray, PhD

Role: CONTACT

ryan.murray@chuv.ch

+41213147485

Facility Contacts

Daniel S Schechter, MD

Role: primary

daniel.schechter@chuv.ch

+41213148558

Ryan J Murray, PhD

Role: backup

ryan.murray@chuv.ch

+41213147485

Other Identifiers

CHUV-SUPEA-01

Identifier Type: -

Identifier Source: org_study_id