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

1. SYNOPSIS OF THE STUDY Sponsor / Sponsor-Investigator Sponsor: Prof. Kerstin von Plessen Sponsor-Investigator: Prof. Daniel S. Schechter Investigator: Mrs. Sandra Rusconi Serpa, MSc, FSP Study Title Feasibility of a brief manualized psychotherapy for traumatized mothers and their young children: Clinician Assisted Videofeedback Exposure Approach Therapy (CAVEAT) Short Title / Study ID CAVEAT Feasibility Study Protocol Version and Date Version 1.0, DATE Study registration Registered on international register (clinicaltrial.gov) provisionally Study category and Rationale This feasibility study conforms to a clinical trial of category A Background and Rationale The present study aims to determine if the manualized brief psychotherapy "Clinician Assisted Videofeedback Exposure-Approach Therapy (CAVEAT)" can be administered to violence-exposed mothers and their young children (ages 1-5 years) in the ambulatory care center of a Swiss public hospital (SUPEA, CHUV) during a psychotherapy of 16 sessions. CAVEAT is based on an amalgam of four existing evidence-based psychotherapy models (Child-Parent psychotherapy, Parental Mentalization, Interaction Guidance, Prolonged Exposure) for parents, infants and young children and traumatized adults that led to the novel, core therapeutic technique developed by Prof. Schechter and colleagues "Clinician Assisted Videofeedback Exposure Session(s) or "CAVES" which has been shown to be successful in positively altering mothers' perception of their young children in two open trials. From the existing literature, the investigataors know that parent-child relationship-based psychotherapies improve significantly maternal sensitivity to their child's communication, which is in part based on maternal capacity to perceive more accurately the young child's emotional communication and to take the child's perspective. Moreover, dyadic psychotherapy models using video-feedback and support of parental mentalization have been shown across models more generally to improve the quality of mother-child interaction.

Risk / Benefit Assessment The risks of participating in this study are estimated as minimal (category A). The proposed intervention involves standard, validated psychotherapeutic procedures with the addition of clinician-assisted videofeedback exposure to naturalistic challenges that are typically stressful for young children and that are "in situation" by the clinician in collaboration with the child's mother during the filmed parent-child interaction sessions. This latter technique has been used without complication in both mental health referred and non-referred pediatrics samples with positive clinical effects in both studies. The investigators estimate that the risks of such an intervention are therefore limited. Though, if a matter arises that is severe, urgent or cannot be dealt with in the psychotherapy as conceived in the model, based on the therapist assessment, proper interventions and/or referrals will be made. Regarding the potential benefits

1. An increase in maternal ability to take her very young child's perspective
2. To respond more sensitively to the child's developmental needs and emotional communication,
3. To be aware of what triggers post-traumatic stress during parent-child interactions,
4. Reduction in re-experiencing, avoidance, negative cognitions, and hyperarousal in day-to-day life with one's child
5. Acquisition of increased tools for self and mutual regulation and stress-reduction during are benefits of participating in the study.

If this form of manualized psychotherapy proves feasible to administer in a public hospital outpatient mental health clinic for children, it could potentially be implemented for this group of patients in a study that tests its efficacy in terms of improvement in parental stress, maternal sensitivity, and reduction of parent-child relational disturbance, potentially benefitting the larger group of these difficult-to-treat child-parent dyads.

Objective(s) The aim of the submitted study is to determine whether the manualized, brief child-parent psychotherapy CAVEAT can be feasibly performed in a child and adolescent psychiatric ambulatory care center at the CHUV, a public university-hospital, this with child and mothers who have experienced IPV and who present to the clinic with concerns about their child's risk for emotional and/or behavior difficulties and/or who note relational disturbances with their very young children ages 1-5 years and/or problems with their parenting.

Aim 1: To assess the feasibility of the recruitment procedures and adherence to treatment among patients, mother, and child therapeutic alliance as well as in terms of the mother and child satisfaction.

Aim 2: To assess if CAVEAT evaluation measures (questionnaires and observed interactions) will be found appropriate, adequate, and sensitive by patients and therapists to the outcomes targeted Aim 3: To assess if CAVEAT for the therapists is feasible to administer in terms of the application of the psychotherapy manual and the psychotherapy procedures involved to the clinic population.

Study Design Open-trial feasibility study. Interim, and post-treatment measures of patient and therapist satisfaction and patient-therapist therapeutic alliance and agreement on treatment goals and realization of treatment objectives. Counts of number of completed sessions and drop-outs before completing the full course of therapy will be noted as well as the clinical supervisor's assessment of therapist adherence to the CAVEAT manual.

Statistical Considerations As this is an open feasibility study of 12 participant-dyads only, results will be in terms of descriptive statistics, counts, and percentages.

Control Intervention: There is no control group or intervention in this pilot feasibility study.

Study procedures As a feasibility study, the present study will implement and check the procedures related to recruitment; inclusion, retention vs drop-out; questionnaire completion and interviews; recording and transcription.