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NCT Number: NCT06552832

CAVEAT: An Open-Trial Feasibility Study

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.

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Key information

Age range

12 month–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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);

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAVEAT

Other

Brief manualized parent-child psychotherapy

Primary outcomes

  1. Parenting Stress Index- Short Form

    Time frame: Pre- and Post-Intervention within 6 weeks after last session

    Self-report questionnaire

  2. Maternal Attributions Rating Scale

    Time frame: Pre- and Post-Intervention within 6 weeks after last session

    Clinician-rated measure

  3. Brief Infant-Toddler Social Emotional Assessment

    Time frame: Pre- and Post-Intervention within 6 weeks after last session

    Maternal-report questionnaire

Secondary outcomes

  1. Intervention Satisfaction Questionnaire

    Time frame: Post-Intervention within 6 weeks after last session

    Maternal and Therapist completed questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel S Schechter, MD

CONTACT

[email protected]

+41213148558

Ryan J Murray, PhD

CONTACT

[email protected]

+41213147485

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Collaborators

  • Sandra Rusconi Serpa

Registry information

Official study title

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

Acronym: CAVEAT-OT

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 14, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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