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RecruitingNCT06552832CAVEAT-OTUpdated Aug 14, 2024

CAVEAT: An Open-Trial Feasibility Study

An interventional study of CAVEAT in Parent-Child Relations, PTSD and Dissociation, sponsored by University of Lausanne Hospitals. Recruiting at 1 site in Switzerland. Open to participants aged 12 Months to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-14.

Sponsored by University of Lausanne Hospitals · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
12 Months to 50 Years
Sex
All
01

Study 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.

Read the 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);

02

Conditions studied

  • Parent-Child Relations
  • PTSD
  • Dissociation

Keywords

  • Brief Psychotherapy
  • Videofeedback
  • Mentalization
  • Infant Mental Health
  • Parenting
  • Interpersonal Violence
03

In context

Stress Disorders, Post-Traumatic

2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.

This study's planned enrollment of 20 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

University of Lausanne Hospitals is the lead sponsor of 120 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • French-speaking, biological child living with mother

Exclusion criteria

Exclusion Criteria:

  • Physical and/or mental handicap that can interfere with participation in play and measures, active psychotic illness or substance abuse
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    CAVEAT

    Clinician-Assisted Videofeedback Exposure

    Other: CAVEAT

Interventions

  • OtherCAVEAT

    Brief manualized parent-child psychotherapy

06

What researchers measure

Primary outcomes

  1. Parenting Stress Index- Short Form

    Self-report questionnaire

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

  2. Maternal Attributions Rating Scale

    Clinician-rated measure

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

  3. Brief Infant-Toddler Social Emotional Assessment

    Maternal-report questionnaire

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

Secondary outcomes

  1. Intervention Satisfaction Questionnaire

    Maternal and Therapist completed questionnaire

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

07

Study locations

1 of 1 sites recruiting
  • Lausanne University Hospital, Child & Adolescent Psychiatry Service
    Lausanne, Vaud 1004, Switzerland
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06552832
Collaborators
Sandra Rusconi Serpa
Responsible party
Daniel Schechter (Associate Professor and Senior Consultant in Child & Adolescent Psychiatry, University of Lausanne Hospitals) — Principal investigator
First posted
Aug 14, 2024
Start date
Jul 1, 2024
Primary completion
Sep 30, 2025 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Aug 14, 2024

Study contacts

Daniel S Schechter, MD
Contact
daniel.schechter@chuv.ch
+41213148558
Ryan J Murray, PhD
Contact
ryan.murray@chuv.ch
+41213147485

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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