Clinician-Assisted Videofeedback Exposure-Approach Therapy (CAVEAT) Trial

NCT05927324 | Recruiting DMC

• 1 other identifier: SPECTRE-CAVEAT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The first study proposed is a small (n= 10 to 12 maximum) open feasibility trial of CAVEAT which is a 16-session manualized brief psychotherapy prototcol that is designed to help mothers of infants and young children, whereby the mothers have been exposed to interpersonal violence (i.e. childhood maltreatment and family violence, intimate and non-intimate partner violence, interpersonal combat and or other forms of terrorism or political violence including physical and sexual assault) and who have developed related post-traumatic stress. The treatment uses an integration and extension of evidence-based techniques: Modified Interaction Guidance, Prolonged Exposure Therapy for PTSD, Child-Parent Psychotherapy, and Minding the Baby, in order to help mothers with post-traumatic dysregulation and difficulty in their maintaining sensitivity during challenging parent-child interactions (i.e. when mothers are confronted with child helpless states, emotion dysregulation, negative affect and child aggression). Outcome measures will initially include: maternal attributions towards her child (i.e. perception of child's personality), maternal-child behavior, and maternal-child symptoms of attachment disturbance and PTSD. This feasibility study is meant to perfect the manual and to prepare for an initial open trial with a larger clinical sample including analysis of pre- and post-intervention measures before further randomized control study can be done.

Conditions

Post-traumatic Stress Disorder

Keywords

Interpersonal Violence; PTSD; Women; Infants and Children; Attachment

Outcome Measures

Primary Outcomes (1)

• Treatment Satisfaction Questionnaire

  Parental and Therapist individual self-report questionnaire

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Parenting Stress Questionnaire-Short Form

  through study completion, an average of 1 year

• Maternal Attributions Rating Scale

  through study completion, an average of 1 year

Study Arms (1)

Active treatment

EXPERIMENTAL

CAVEAT active treatment group

Behavioral: CAVEAT

Interventions

CAVEAT BEHAVIORAL

Brief psychotherapy with mothers of infants and young children, to which infants and young children attend many but not all sessions with mother

Active treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Biological mothers of infants and young children ages 12-54 months
• Mothers and infants have lived together most of the child's life from the time of birth

You may not qualify if:

• Actively psychotic or substance-abusing mothers;
• Mothers and/or children who are physically or mentally handicapped so as to prevent adequate participation in required research tasks

Sponsors & Collaborators

• University of Lausanne Hospitals: lead
• International Psychoanalytical Association: collaborator

Study Sites (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, 1004, Switzerland

RECRUITING

Related Publications (2)

• Schechter DS, Moser DA, Reliford A, McCaw JE, Coates SW, Turner JB, Serpa SR, Willheim E. Negative and distorted attributions towards child, self, and primary attachment figure among posttraumatically stressed mothers: what changes with Clinician Assisted Videofeedback Exposure Sessions (CAVES). Child Psychiatry Hum Dev. 2015 Feb;46(1):10-20. doi: 10.1007/s10578-014-0447-5.

  PMID: 24553738 BACKGROUND

• Schechter DS, Myers MM, Brunelli SA, Coates SW, Zeanah CH, Davies M, Grienenberger JF, Marshall RD, McCaw JE, Trabka KA, Liebowitz MR. Traumatized mothers can change their minds about their toddlers: Understanding how a novel use of videofeedback supports positive change of maternal attributions. Infant Ment Health J. 2006 Sep;27(5):429-447. doi: 10.1002/imhj.20101.

  PMID: 18007960 BACKGROUND

Related Links

• Link to CAVEAT concept introduction article (in German)

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Daniel S Schechter, MD

CONTACT

+41213145285; daniel.schechter@unige.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: July 3, 2023
• Study Start: July 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)