Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04748731 |
| Other study ID # |
VF and mentalizing |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
January 25, 2022 |
Study information
| Verified date |
January 2021 |
| Source |
Pontificia Universidad Catolica de Chile |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Title: "Internet mentalization-based video feedback intervention to improve parental
sensitivity in mother-infant dyads with maternal depressive symptoms: randomized controlled
feasibility trial". Funding: ANID Millennium Science Initiative /Millennium Institute for
Research on Depression and Personality-MIDAP ICS13_005 (MIDAP, www.midap.org).
Principal Investigator: Marcia Olhaberry Huber, PhD, Academic, School of Psychology,
Pontificia Universidad Católica de Chile, Associate Researcher, MIDAP.
MIDAP Research Team: Javier Moran, PhD. Academic at the University of Valparaíso, María José
León, PhD, Stefanella Costa, PhD. and Fanny Leyton, PhD. (c) University of Valparaíso.
General Objective: To evaluate feasibility and acceptability of a brief Internet
mentalization-based video feedback intervention to improve sensitivity in mothers with
depressive symptoms. Key parameters for a future effectiveness study will be identified
Design: Pilot randomized clinical trial; Participants: 60 mother-infant dyads (aged 4-12
months) attended in Public Health Centres.30 dyads will be assigned to the experimental group
(EG) and will receive a weekly online brief intervention using video-feedback and
psycho-educational materials on early parenting. 30 dyads will be assigned to the control
group (CG) and will receive only psycho-educational materials. The study includes 3
assessments (pre-intervention, post-intervention and follow-up) and four weekly intervention
sessions. Data analysis: For quantitative data descriptive statistics and ANCOVA will be
used, for qualitative data Grounded Theory.
Description:
Background A growing body of research recognises the key role of both parental sensitivity
and mentalizing in fostering positive parent-child relationships. This, in turn, is
fundamental for a child's mental health and intergenerational transmission of attachment.
Parental sensitivity concerns a parent's ability to perceive and interpret their child's cues
accurately and to respond accordingly in a contingent manner (Ainsworth et al., 1978).
Parental sensitivity has been associated with the development of attachment and general
socio-emotional development in childhood. The association between parental sensitivity and
cognitive variables like joint attention, executive functioning development in early
childhood and Theory of Mind in preschoolers has also demonstrated it.
The caregiver's capacity to think of his/her child in terms of mental state (i.e., parental
mentalizing or parental reflective functioning) is linked with the development of affect
regulation in the child, with the intergenerational transmission of attachment and with the
development of social and reflective abilities in childhood. Evidence also suggests that
mentalizing may constitute a protective factor for the transmission of psychopathology in
childhood.
*THE INTERVENTION*
The present intervention aims to improve parental sensitivity and mentalizing in depressed
mothers using a model based on video-feedback methodology in an online modality.
The whole intervention consists of 4 sessions plus 1 pre-intervention assessment session.
Additionally, there is 1 weekly group supervision, along with the therapist independent work
on the case between sessions. Each intervention's session has the same structure: Checking
outcomes from the previous session; Videofeedback; New video recording; Post-interview; Tasks
definition.
Between each session, the therapist analyses the material independently and attends group
supervision. Each element of the intervention is described in detail below.
PRE-INTERVENTION ASSESSMENT Methodology: Online, delivered by a trained clinical psychologist
Duration and frequency: 90 minutes, once.
1. Questionnaires and scales:
1. Sociodemographic information questionnaire
2. Children social-emotional screening (ASQ SE).
3. Mothers depressive symptoms (Edinburgh Postnatal Depression Scale; EDPS; Patient
Health Questionnaire; PHQ-9)
2. Video recording of free mother-baby play at the end of the session (coded with the
Emotional Availability Scale; EAS).
3. MINI PDI interview (after video recording).
4. Childhood Trauma Questionnaire Short Form (CTQ-SF)
5. Examination of the mother's concerns regarding the child, their relationship, or her as
a mother. Discussion of the mother's reason for referral and intervention goals
definition, integrating the mother's concerns.
THERAPIST INDEPENDENT WORK General Description: Review of case's background information,
video analysis and VF script elaboration Duration and frequency: 60 minutes weekly. The free
play video -recorded in the initial assessment is watched and analysed, and then resources
and opportunities are identified.
The intervention's goal 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's 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 the positive
sequences or selecting specific images within the video.
Specific goals to be achieved in each selected segment must be identified. Comments and
questions to be made by the therapist should be defined, and these should be linked to each
selected segment's goal.
SUPERVISION Methodology: Online group supervision. Duration and frequency: 120 minutes
weekly. Guidelines: Two guidelines are provided and examined. These documents were developed
to orient both online psychotherapeutic processes in early childhood and psychotherapeutic
interventions using video feedback in 0-5 years old children.
After the therapist prepares their 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 results, the complete videos, the completed analyses, the segment
selected and the elaborated script. At further sessions, the therapist would have to present
not the whole process but only particular aspects of each case or about his work as a
therapist.
The supervision has a reflective methodology, and the experience of each of the
intervention's participants is considered (i.e., supervisor, child, caregiver and therapist).
In the supervision space, the supervisor can also act as a supportive figure for the
therapist.
INTERVENTION'S SESSIONS Methodology: Online and delivered by the same therapist that made the
initial assessment. Duration and frequency: 60 minutes weekly.
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 former session's
tasks.
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 Video Feedback intervention's goal is
presented to the mother, explaining its benefits and exploring their perceptions around this
issue.
Then, the video sequences previously selected are shown. Before commenting, it is important
to ask the mother to observe and describe objectively (i.e., without making inferences) what
she is watching, to check that both caregiver and therapist are watching the same and
therefore, reflecting about the same contents. For example, a caregiver watching a video
might say "my son does not want to play with me" when the child is focused on playing with a
toy. In those cases, it can be useful to ask the mother again to describe what was watched
without interpreting. In this way, we check that we are both watching the same, which is key
for our comments to be well received.
Video Recording. Each session has a moment when a new interaction following a new instruction
is recorded (e.g., playing, feeding, singing).
Post-Interview. After each video recording, a semi-structured interview is carried out with
the following questions:
(About the mother herself) What was the most pleasant aspect of the interaction with your
baby? Why? What was the most difficult aspect of the interaction with your baby? Why? (About
the baby) What do you think was the most pleasant aspect of the interaction for your baby?
What made you think that ___ was the most pleasant aspect for your baby? What do you think
was the most difficult aspect of the interaction for him/her? What made you think that___ was
the most difficult aspect for him/her? (About the interaction) Has this type of interaction
with your baby happened before? (if yes) Could you please give me an example? Could you
describe what caught your attention or what you learned about yourself, your baby or your
relationship after this interaction?
Tasks definition: behaviours or activities to perform during the week are defined. 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.
*THE STUDY*
Design: Cluster randomized controlled trial feasibility and pilot study
Participants: Mothers presenting depressive symptoms will be invited from three public
primary health centres from Santiago, Valparaíso and Puerto Varas. Sample size will be 60
(control group [CG]=30; experimental group [EG]=30), based on similar studies and general
recommendation for pilot studies1819.
Professionals delivering the intervention must be psychologists with at least 1 year of
experience.
Procedure: Participants will be invited by a primary health worker. On participation
agreement, they will be contacted to perform the first interview to assess eligibility and
sign an informed consent (as established by the PUC Ethical Committee). After that,
participants will be randomized to CG or EG in a 1:1 ratio. A random number sequence will be
computer-generated in varying block sizes (2&4) and stratified by centre.
Based on a mentalization-based VFI developed by Olhaberry and colleagues aimed to improve
maternal sensitivity, a 4 sessions internet VFI will be manualized. Therapists will be
trained in the model over 3 days (24 hours) and then supervised session by session. The
CORE-OM and an assessment of the therapist's adherence to the model will be used during
supervision. For this purpose, each session will be video recorded.
CG, psycho-educational intervention: They will receive weekly information on parenting in the
1st year of life. They will have direct contact (via WhatsApp) with a child psychologist to
ask questions about the material and to refer to specialized support if needed.
Outcome measures will be taken before the first session, after treatment, and in a 3 -months
follow up period.
Instruments: 1. Sociodemographic information questionnaire; Parental Sensitivity (Primary
Outcome; Emotional Availability Scale; EAS; 2. Secondary outcomes: Parental Reflective
Functioning (Parent Development Interview-Revised, Short Version; PDI-R); Children
Social-emotional screening 3. Covariates: Mothers depressive symptoms (Edinburgh Postnatal
Depression Scale; EDPS; Patient Health Questionnaire; PHQ-9); Childhood Trauma Questionnaire
Short Form (CTQ-SF)
Analysis plan
Quantitative Outcomes: Descriptive statistics to establish CG's and EG's clinical and
sociodemographic variables, eligibility and recruitment rate, and adherence. ANCOVA will be
used to determine differences between groups, controlling for a baseline for each outcome.
Observational measures will be applied by a certified pair of coders. Cohen-kappa will be
used for Inter-rater reliability. Qualitative study: to assess participant's satisfaction
with the intervention, semi-structured interviews will be conducted after the trial's end. 4
mothers from each centre will be interviewed, selected according to the presence/absence of
change in the main outcome (2 presenting change/2 not presenting change, to ensure
variability). Additionally, a focus group will be performed with VF therapists (3
professionals for each centre; 9 in total). Interviews aim to collect information regarding
the feasibility of performing the intervention and also training and supervision experience.
Interviews' data will be analyzed using Grounded Theory´s open coding.
