A small randomized controlled feasibility trial incorporating a qualitative component has been designed to assess feasibility and acceptability of a brief online intervention using VF and to collect parameters that may serve as the rationale for the implementation of a large randomized clinical trial (RCT) in the future. See Figure 1.
Settings and participants
The research will take place in five Chilean public primary health centers located in Santiago, Valparaíso and Puerto Varas. The quantitative aspects of the study will be conducted amongst mothers with depressive symptomatology and babies aged between 4 and 12 months old, enrolled at the Centers. The sample will comprise all mothers that meet the inclusion criteria, do not meet exclusion criteria and wish to participate during recruitment period (starting in March 2021 and ending in January 2012). The expected sample size is 60 mother-baby dyads in total, 30 for the control group and 30 for the experimental group. Participants will be randomized to control group or experimental group in a 1:1 ratio. A random number sequence will be computer-generated in varying block sizes (2&4) and stratified by center. If by January 2022 the total sample has not been met, more dyads will be recruited in order to reach the sample size.
- Be over 18 years old
- Have a 4 to 12 month old infant
- Be a user of primary public health
- Score at least 5 points in the EPDS during routine health controls in health centers
- Speak Spanish fluently
- Mothers presenting severe intellectual deficit or psychotic symptoms.
- Infants presenting severe developmental disorders (intellectual impairment and/or severe developmental delay) and/or at high risk of abuse or neglect (current domestic violence, current legal process for children rights infringement, primary caregiver in conflict with the law)
For the qualitative component of the study, a group of 4 mothers from each center will be interviewed using a semi-structured interview. Additionally, three therapists and three health professionals from the public health center will attend a focus group.
As a feasibility study, no hypothesis will be tested and, therefore, a formal power calculation is not required 30,31. Considering similar studies and general recommendations for pilot studies 32,33. We aim to recruit 60 participants in order to estimate key parameters for a future RCT.
Control group: treatment as usual (TAU) + psychoeducational cards
The control group mother-baby dyads will receive psychoeducational cards about parenting and, just like the experimental group, they will receive the usual attention from the public health center (development monitoring, breastfeeding support, maternal depressive symptoms monitoring)
Intervention arm: TAU + Video Feedback + psychoeducational cards
The proposed intervention has been developed considering other evidence-based interventions using VF with mother-baby dyads like: Attachment and Biobehavioral Catch-up (ABC), (Dozier, & Bernard, 2017), Video-feedback Intervention to promote Positive Parenting VIPP-SD 34, Group Attachment-Based Intervention (GABI)35,36, Minding The Baby37,38, Video Intervention Therapy (VIT)8, ODISEA model39,40 And two Chilean interventions conducted by clinical researchers from this study, aimed at fostering parental sensitivity, improving quality in family relationships, and improving socio-emotional childhood development 41–43. This Mentalization Informed VF (MI-VF) intervention is explicitly tailored to suit the needs of mothers with depression and their 4-12 months old babies. It consists of 4 sessions and is suitable to be delivered remotely. The implementation model considers 30 hours of training for therapists, including weekly supervision in groups in which videos are analyzed and each case is discussed.
The present intervention aims to improve parental sensitivity and mentalizing in depressed mothers by using a model based on video feedback methodology in a virtual modality. The whole intervention consists of four sessions plus one pre-intervention assessment session. Additionally, there is one weekly group supervision, along with the therapist independent work on the case between sessions. Each intervention session has the same structure (see figure 2).
The whole intervention process will be carried out through online methodology by trained clinical psychologists and, in addition, it will be recorded for the purpose of clinical work under supervision.
Elements of the intervention process are described below:
Pre-intervention assessment. Duration: 90 minutes (see section “measures”). The main goal of this assessment is to collect the necessary information in order to evaluate the mother (EDPS; PHQ-9, CTQ-SF, ECR), the baby (ASQ:SE-2) and the dyad (Sociodemographic information questionnaire, Video recording of free mother-baby play at the end of the session; MINI PRFI). In this session the first video recording of the mother-infant interaction is carried out. Also, an examination of the mother’s concerns regarding the child, their relationship or about her as a mother is performed together with a discussion of the mother’s reason for referral and intervention goals, integrating mother’s concerns.
THERAPIST INDEPENDENT WORK: 60 minutes in duration, weekly frequency. The main goal of this element is the review of the case’s background information, video analysis and VF script elaboration.
The free play video -recorded in the initial assessment is watched and analyzed, and then resources and opportunities are identified. The general goal of the intervention is defined considering the mother’s concerns and the reason for referral defined in the initial assessment.
Segments of 30 and 60 seconds are selected by stopping the video at the end of the interaction sequence. Both the start and end times are written down on the script. It is recommended to show the complete video unless negative segments are identified (i.e., segments in which the mother appears as hostile or insensitive, when the child appears severely under regulated). In such cases, it might be necessary to consider only positive sequences, or selecting specific images within the video (i.e., it is not recommended to show the complete video in those cases, but only images of specific moments).
Please note: It is necessary to stop the video when both participants are seen in a positive moment of the interaction because this will be the image on which the reflection will be made.
Specific goals to be achieved in each selected segment must be identified (for example, to enhance mentalizing.)
Comments and questions to be made by the therapist should be defined, and these should be linked to the goal of each selected segment (e.g., How do you imagine that your baby felt when you took her hands and you sang her song together?)
Supervision. Duration 120 minutes, weekly frequency and group methodology.
The main goal of this element is to reflect and orient the therapeutic processes.
After the therapist prepares his/her first case, they must present to the group at least 1 complete VF process. Then, they must present parts of the other cases they will address. In the first case, the therapist must present a comprehensive diagnosis of the case integrating the initial assessment’s results, the complete videos, the completed analyses, the segment selected and the elaborated script. At subsequent sessions the therapist would have to present only particular aspects of each case or about his work as therapist rather than the whole process.
The supervision has a reflective methodology 44 and the experience of each one of the intervention’s participants is considered (i.e., supervisor, child, caregiver and therapist). In the supervision space the supervisor also can act as a supportive figure for the therapist. This, in time, helps to make sense of the family’s experiences35.
The supervision space is necessary both for the therapists training and as an opportunity for processing their own experiences and emotions related to the work with the families. In this way, the supervision promotes: a) the reflective functioning of the therapists, particularly regarding the family’s interactions; b) the therapist as a “collaborator” of the caregivers, a role from which he/she can strengthen the caregivers’ resources and abilities and those of the child, through the reflective space that video-feedback allows.
Video-feedback intervention’s sessions. 60 minutes in duration, weekly. The main goal is to work with the dyad considering the therapeutic focus selected for the whole process and for each session. It is delivered online and by the same therapist that made the initial assessment.
Checking outcomes from the previous sessions. Starting from session 2. A space for discussing the caregiver’s perceptions about changes in the relationship related to the tasks defined in the former session.
Video Feedback. The topic of each session addresses the contents of the video recorded in the previous session. First, the structure of the session is explained to the mother. Next, the mother is asked about the video recorded -this is useful to check if what she remembers is consistent with what was observed-. After that, the goal of the Video Feedback intervention is presented to the mother, explaining its benefits and exploring their perceptions around this issue. Then, the video segments previously selected are shown.
The selected segments are addressed as follows: 1) Observe; to attentively observe the segments checking that the mother is able to watch and to listen correctly. 2) Describe; the mother is asked to observe and describe objectively (i.e., without making inferences) what she is watching, in order to check that both caregiver and therapist are watching the same and, therefore, reflecting about the same content. 3) Mentalize; to reflect on a dialogue with the mother drawn from the comments and questions stated on the video-feedback script. The mother is encouraged to reflect on the possible mental states that motivated each member of the dyad’s behaviors and its implications. She is also invited to reflect on how those mental states are present in everyday life.
It is recommended to show the complete video unless negative segments are identified in which the mother shows herself as hostile and/or insensitive or if the child is too disorganized. In those cases, the sequences with positive aspects should be considered or otherwise pictures of specific moments can be selected instead of the video.
Important: The video must be stopped when both participants are seen in a positive moment of the interaction because this will be the image they reflect on.
Video Recording. Each session has a moment in which a new interaction following a new instruction is recorded (e.g., playing, feeding, singing).
Post video interview: After each video recording, a semi-structured interview is carried out briefly addressing the mother’s experience within the interaction (e.g., What was the most pleasant aspect of the interaction with your baby?), the baby’s experience (e.g., What do you think was the most pleasant aspect of the interaction for your baby?), and the experience of both mother and child (e.g., Has this type of interaction with your baby happened before?)
Task’s definition: behaviors or activities to perform during the week are defined at the end of the session. These can be proposed by the therapist or emerge from what the mother learnt in the video feedback. Examples: playing 5 minutes, 3 times per week with; observe the baby’s preferences in a specific context, support the baby in reaching a new ability; among others.
Mothers with 4- to 12-month-old babies attending primary public health centers will be invited to participate by a healthcare professional. On participation agreement, they will be contacted to perform a first interview to assess eligibility (5 points on EDPS) and to sign an informed consent and a letter of authorization for their baby's participation. At any time, participants could drop the study by contacting the study coordinator (same person who make first contact with them).
Once the dyads are enrolled in one of the two groups, the pre-intervention assessment will be carried out, which evaluates: depressive symptoms (EDPS, PHQ-9), Maternal sensitivity (EAS), child’s socio-emotional development (ASQ-SE), adult attachment (ECR), adverse experiences during childhood- short form (CTQ-SF) credibility and expectative of the treatment (CEQ) and therapeutic progress (CORE-OM). After that, interventions for both groups will be implemented followed by the post intervention assessments and, after three months of the intervention’s ending, a follow-up assessment. Evaluations and interventions are detailed in figure 3.
Randomization and blinding
Participants will be randomly assigned to either CG or EG in a 1:1 ratio. A random number sequence will be computer-generated from permuted block sizes 4 and 6 using studyrandomizer ®45. The sequence will be administered by an external person who will be contacted by the study’s coordinator each time a participant joins the study.
The outcome assessors will be blinded (even though participants and therapists will not).
The feasibility will be evaluated in terms of eligibility rates, recruitment rates and reason for study refusal, data attrition and follow-up by treatment condition.
Acceptability of the intervention
The intervention's acceptability will be assessed through in-depth interviews carried out to the mother participants. Additionally, a focus group with therapists and healthcare workers from the referral centers will be performed to explore their assessment of and levels of satisfaction with the intervention.
The secondary outcomes will be changes in maternal sensitive response, reflective functioning, depressive symptomatology and socioemotional development, as detailed in figure 4.
- Sociodemographic information questionnaire: elaborated by the research team with the goal of describing the participant’s sociodemographic, clinical and family background. It will be applied during the initial pre-intervention assessment.
- Emotional Availability Scale EAS46. This scale will be used to codify the 15-minute mother-infant interaction video to assess maternal sensitivity, the primary outcome of this intervention. The research team has 3 members trained and certificated in this scale. This will ensure an adequate interrater reliability. This scale and its required videos will be recorded during the pre, post and follow-up assessments and subsequently codified.
- MINI Parental Development Interview, MINI-PRFI47. After the video recordings, this interview will be applied to assess reflective parental functioning or mentalizing, which is the secondary outcome of this study. This instrument uses the Slade et al., (2004) codification system. The interviews will be recorded, transcribed and codified. The research team has 4 members trained and certificated in this scale. This will ensure an adequate interrater reliability.
- Ages and Stages Questionnaire, ASQ-SE48. Screening instrument that assesses difficulties in children’s socioemotional development from 3 to 60 months. Eight questionnaires are available for different age groups: 6, 12, 18, 24, 30, 36, 48, and 60 months of age. Each screens for self-regulation, compliance, communication, adaptive behaviors, autonomy, affect, and interaction with people. The Spanish version will be used, which has shown good psychometric properties. It will be used in the pre, post and follow-up assessments.
- CORE Outcome Measure (CORE System Group49. This self-report measure comprises 18 items and assesses therapeutic outcomes focusing on the following dimensions: Well-being; Problems/symptoms: Anxiety levels, depression, trauma and physical symptoms; Functioning: interpersonal, social and general functioning in daily life; Risk/harm’ includes items covering harm to self and suicidal ideation (risk-to-self items) and violent behavior and threats towards other people (risk-to-others items). Each item is scored on a Likert scale that goes from 0 to 5. CORE OM has shown high reliability (Cronbach alpha of .7 and .9 in all subscales50. It will be used in the pre, post and follow-up assessments, as well as in each intervention session.
- Patient Health Questionnaire, PHQ-951. Depressive Symptomatology Covariable. Self-report questionnaire comprising 9 items scored in a 0-3 Likert scale developed for depression screening. It has been validated for the Chilean population52. The PHQ-9 has shown high reliability (Cronbach=.89) and an adequate convergent validity (Hamilton scale r=.75) Sensitivity analyses demonstrate that the PHQ-9 allows the identification of 86.4% of major depression cases. It will be used in the pre, post and follow-up assessments.
- Edinburgh Postnatal Depression Scale, EDPS53. Depressive Symptomatology Covariable. The EDPS self-report questionnaire comprising 10 items developed for depression screening. Has shown a 76.7% of sensitivity and a 92.5% of specificity for perinatal depression. Of a total of 30 points, scores of 12 or higher indicate probabilities of depression. It will be used in the pre, post and follow-up assessments
- Experience in close relationships, ECR54. Self-report questionnaire comprising 36 items assessing adult attachment anxiety and avoidance dimensions; each dimension corresponds to a scale, with 18 items each, assessed on a 7-point Likert scale where 1 means “totally agree” and 7 means “totally disagree”. The ECR has shown high reliability in its Chilean adaptation, which range from .81 and .84 in both subscales55.
- Childhood Trauma Questionnaire- Short Form (CTQ-SF56). CTQ-SF is a 28- item self-report questionnaire that retrospectively assesses adverse childhood experiences in adolescents and adults. Its development was based on the 70-item instrument constructed by Bernstein et al., (1994) through an exploratory and confirmatory factorial analysis. It evaluates five types of childhood adverse experience: emotional abuse, physical abuse, sexual abuse, emotional neglect and physical neglect, with five items per scale. Each item is answered through a 5-point Likert scale that goes from almost never true to almost always true. Three additional items allow the identification of socially accepted responses or false trauma reports. Internal consistency coefficients for the English version are between 0.84 to 0.89 for emotional abuse, 0.81 to 0.89 in physical abuse, 0.92 to 0.95 in sexual abuse, 0.85 to 0.91 for emotional neglect and 0.61 to 0.78 for physical neglect56. It was validated for Chilean population, evidencing adequate psychometric properties57
- Credibility/Expectancy Questionnaire, CEQ58. The CEQ assesses acceptability of the online intervention. It is a self-report questionnaire comprising 6 items scored in a 9-points Likert scale ranging from 1 to 9 and two factors (credibility and expectative) that explain the 82.46% of the variance. The questionnaire has shown adequate reliability with a Cronbach’s Alpha of .80. The CEQ will be used in the pre, post and follow-up assessments
- Semi-structured interview for qualitative study. During the development of the research 3 scripts for interviews will be applied, all of them at the end of the intervention. The scripts consist of:
- First script: to explore the participant’s subjective experience in depth regarding their perception of the intervention, adherence and usefulness.
- Second script: to interview key healthcare workers from the partner health centers aiming to gather information regarding feasibility of developing this intervention. Questions are aimed at analyzing the resources needed and the impact of the intervention in the center’s usual operation.
- Third script: for interviewing the intervention’s therapists to know their perspective regarding the intervention’s modality, their perception on the difficulties and benefits for mothers and for them as therapists. Interviews were designed for the principal investigator together with the research team and can be found as an appendix.
 It has been found that the frequency and quality of the “in vivo” feedback to parents predict the size of the change after the interventions as well as the improvement in parental sensitivity (Caron, Bernard, & Dozier, 2018).
Research governance and ethics
The study will comply with local research governance requirements.
Full ethical approval was obtained from the local Ethics Committee (Comité Ético Científico de Medicina, Pontificia Universidad Católica de Chile, ID 201201009, date 17-12-20). Informed and written consent will be obtained from the participants.