CAVEAT: An Open-Trial Feasibility Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CAVEAT.
- Who it may be relevant to
- Registry conditions: Parent-Child Relations, PTSD, Dissociation. Basic parameters: 12 months — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinician-Assisted Video Feedback Exposure-Approach Therapy (CAVEAT): An Open-Trial of a Brief Psychotherapy for Traumatized Mothers and Their Young Children
Overview
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);
Interventions
- Other CAVEAT
Brief manualized parent-child psychotherapy
Primary outcome measures
- Parenting Stress Index- Short Form [Time frame: Pre- and Post-Intervention within 6 weeks after last session]
- Maternal Attributions Rating Scale [Time frame: Pre- and Post-Intervention within 6 weeks after last session]
- Brief Infant-Toddler Social Emotional Assessment [Time frame: Pre- and Post-Intervention within 6 weeks after last session]
Secondary outcome measures (1)
- Intervention Satisfaction Questionnaire [Time frame: Post-Intervention within 6 weeks after last session]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- Lausanne University Hospital, Child & Adolescent Psychiatry Service — Lausanne
Identifiers
NCT: NCT06552832 · CHUV-SUPEA-01