Parent-Child RelationsCAVEAT-OTNCT06552832
CAVEAT: An Open-Trial Feasibility Study
A study testing CAVEAT in people with Parent-Child Relations and PTSD, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 months to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations, PTSD, Dissociation
- What is being tested?
- CAVEAT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2024to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- French-speaking, biological child living with mother
Who cannot join
- Physical and/or mental handicap that can interfere with participation in play and measures, active psychotic illness or substance abuse
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Lausanne University Hospital, Child & Adolescent Psychiatry Service
Lausanne, Canton of Vaud, 1004
Daniel S Schechter, MD, +41213148558, daniel.schechter@chuv.ch
Ryan J Murray, PhD, +41213147485, ryan.murray@chuv.ch
About this study
Official title: Clinician-Assisted Video Feedback Exposure-Approach Therapy (CAVEAT): An Open-Trial of a Brief Psychotherapy for Traumatized Mothers and Their Young Children
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);
- Conditions
- Parent-Child Relations, PTSD, Dissociation
- Being tested
- CAVEAT
- Keywords
- Brief Psychotherapy, Videofeedback, Mentalization, Infant Mental Health, Parenting, Interpersonal Violence
- Medical subject headings
- Stress Disorders, Post-Traumatic, Dissociative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAVEATOther
Brief manualized parent-child psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| CAVEAT | Experimental | Clinician-Assisted Videofeedback Exposure Receives: Other: CAVEAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting Stress Index- Short Form
Self-report questionnaire
Measured: Pre- and Post-Intervention within 6 weeks after last session
Maternal Attributions Rating Scale
Clinician-rated measure
Measured: Pre- and Post-Intervention within 6 weeks after last session
Brief Infant-Toddler Social Emotional Assessment
Maternal-report questionnaire
Measured: Pre- and Post-Intervention within 6 weeks after last session
Secondary outcomes (1)
Intervention Satisfaction Questionnaire
Maternal and Therapist completed questionnaire
Measured: Post-Intervention within 6 weeks after last session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Jul 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Trial with Pre- and Post-Measures (Treatment as Usual as parallel contrast without randomization)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Sandra Rusconi Serpa
- Responsible party
- Principal investigator, Daniel Schechter, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552832
- Sponsor's protocol ID
- CHUV-SUPEA-01
- Acronym
- CAVEAT-OT
- Status last verified
- Aug 2024
- First submitted
- 6 May 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinician-Assisted Video Feedback Exposure-Approach Therapy (CAVEAT): An Open-Trial of a Brief Psychotherapy for Traumatized Mothers and Their Young Children
- ClinicalTrials.gov ID
- NCT06552832
- Acronym / sponsor ID
- CAVEAT-OT / CHUV-SUPEA-01
- Conditions
- Parent-Child Relations, PTSD, Dissociation
- Keywords
- Brief Psychotherapy, Videofeedback, Mentalization, Infant Mental Health, Parenting, Interpersonal Violence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Collaborators
- Sandra Rusconi Serpa
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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);
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Trial with Pre- and Post-Measures (Treatment as Usual as parallel contrast without randomization)
| Arm | Type | Receives |
|---|---|---|
| CAVEAT | Experimental | Other: CAVEATClinician-Assisted Videofeedback Exposure |
Who may qualify
- Ages
- 12 months to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- French-speaking, biological child living with mother
Key exclusion criteria (1 listed)
- Physical and/or mental handicap that can interfere with participation in play and measures, active psychotic illness or substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAVEATBrief manualized parent-child psychotherapy | Other | CAVEAT |
Primary outcome
Parenting Stress Index- Short Form
Time frame: Pre- and Post-Intervention within 6 weeks after last session
Self-report questionnaire
Maternal Attributions Rating Scale
Time frame: Pre- and Post-Intervention within 6 weeks after last session
Clinician-rated measure
Brief Infant-Toddler Social Emotional Assessment
Time frame: Pre- and Post-Intervention within 6 weeks after last session
Maternal-report questionnaire
1 secondary outcome
Intervention Satisfaction Questionnaire
Time frame: Post-Intervention within 6 weeks after last session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAVEAT in people with Parent-Child Relations and PTSD, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel S Schechter, MD (+41213148558, daniel.schechter@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting Stress Index- Short Form (time frame: Pre- and Post-Intervention within 6 weeks after last session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.