Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04818047 |
| Other study ID # |
CHREB-Ethics ID #: REB16-1811 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2021 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
May 2023 |
| Source |
University of Calgary |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
COVID-19 has placed unprecedented strains on parents impacted by toxic stress (depression,
addiction, intimate partner violence, and poverty) and reluctant to see mental health-service
providers in home/clinic due to fears of infection. Due to the pandemic, Co-PI Letourneau
ceased/delayed recruitment in VID-KIDS a CIHR-funded randomized controlled trials (RCT) of
in-person (home or clinic) program designed to improve children's mental, emotional and
behavioural (MEB) health and development via parent-child relationship intervention.
Recognizing the heightened need for already vulnerable families to obtain safe parenting
support to manage depressive symptoms/other stressors. Our primary knowledge user (D. McNeil,
Scientific Director, Maternal Newborn Child and Youth Strategic Clinical Network, Alberta
Health Services) advocated for online delivery of the VID-KIDS parent training program. In
response, an interdisciplinary team from nursing and software engineering rapidly pivoted to
an online delivery format. Critical barriers to using existing commercial technologies
emerged, making it essential to develop and implement tailored, user-informed virtual care
delivery platforms and tools safe, secure, user-friendly for families already stressed. This
project aligns with the priority research area, Developing Innovative Adaptations of Services
and/or Delivery, as innovative user interface design and integrated knowledge transfer
approaches will be used to: (a) adapt VID-KIDS for virtual delivery; (b) develop virtual
platforms (web-based applications) and tools (mobile apps) for flexible delivery of mental
health supports for parents and training for professional facilitators; (c) integrate virtual
mental health services into the primary care system promoting program uptake; and (d)
design/test streamlined and intuitive virtual systems for nimble spread/scaleup. The project
catalyzes and enriches the PIs' research program by crossing disciplines (nursing &
engineering) in cutting edge research that is responsive to trends in both mental health
intervention and web-interface design. This will be foundational for future tri-council RCT
grants, expanding our research into user-engaged technology-enabled delivery of needed
community interventions, especially relevant to promoting the urgent mental health needs of
Canadian families in the COVID-19 context of physical distancing.
Description:
For Virtual Platform Background: Toxic stressors including parental depression, addictions,
intimate partner violence or low-income undermine parent-child relationship quality, placing
children at risk for mental, emotional and behavioural (MEB) health and development problems.
COVID-19 has placed unprecedented strains on already vulnerable families. Postpartum
depression (PPD), for example, affects ~19% of mothers and is considered toxic to children's
mental health and development because it reduces maternal sensitivity and positive
responsiveness to infant/child cues and bids for caring attention. While depressed mothers
benefit from support, COVID-19 has reduced depressed mothers' access, placing their
children's mental health and development at heightened risk. Exposure to toxic stress
increases children's risk for poor lifetime mental health trajectories. Ensuring that parents
and children receive support to address the impact of toxic stress, especially given service
reductions associated with COVID-19, is crucial to promote children's' mental health. Our aim
is to build on the success of two CIHR funded in-person (home or clinic) intervention program
designed to improve parent-child relationship quality and children's MEB health and
development by transitioning to virtual delivery. In response to ceased/delayed recruitment
in both study and increased demand for parent-child mental health services related to the
pandemic, the research team rapidly adapted to virtual delivery in collaboration with
principal knowledge user (D McNeil, Scientific Director, Maternal Newborn Child and Youth
Strategic Clinical Network, Alberta Health Services). Our efforts revealed unsurmountable
barriers to using commercially available technologies and affirming the need to develop and
implement user-informed virtual care delivery platforms and mobile tools.
VID-KIDS Program (Video Feedback Interaction Guidance Program for Depressed Mothers and their
Infants), was designed specifically to help mothers with PPD to be sensitive and responsive
to their infants, an ability that is undermined by the symptoms of depression, in order to
promote healthy child development. As both program have been demonstrated to be effective in
clinic and home visits, both are positioned for transition to virtual formats and the timing
is ripe for rapid uptake in Canada.
Methods: Using integrated knowledge transfer (iKT) and participatory design approaches,
investigators will develop and pilot test a virtual program for real-world implementation, by
evaluating the impact of the beta prototypes on maternal-infant interaction quality and
children's MEB health development. Interdisciplinary collaboration is vital to ensure the
relevant expertise to develop accessible secure, safe, user-friendly and feasible virtual
mental health intervention for VID-KIDS. To ensure usability of the virtual platforms,
investigators will undertake four-phase study for VID-KIDS: Phases 1 and 2: Exploratory -
user engagement to identify content and explore design challenges and user preferences,
followed by prototyping of interface designs; Phase 3: Software Development - iterative
design sessions with users to develop MVPs; and Phase 4: Pilot Test - beta test MVPs and
refine user interface designs. The impact of the beta prototypes on parent-infant interaction
quality and children's mental health and development will be assessed.
Relevant Research Areas: This project directly aligns with the priority research area,
Developing Innovative Adaptations of Services and/or Delivery, in that user interface design
(UID) and iKT approaches will be used to: (a) adapt the innovative VID-KIDS program for
virtual delivery; (b) develop virtual platforms (web-based applications) and tools (mobile
apps) for flexible delivery of mental health supports for parents and training for
professional facilitators; (c) integrate virtual mental health services into the primary care
system to promote program uptake; and (d) design/test streamlined and intuitive virtual
systems that can be easily spread and scaled. T his work will set the stage for two
tri-council randomized controlled trial (RCT) grants, expanding our research into
user-engaged technology-enabled delivery of needed community interventions, especially
relevant to promoting the mental health of Canadian families in the COVID-19 context of
physical distancing.
For VID-KIDS Program Background & Rationale: Affecting ~19% of mothers, postpartum depression
(PPD) reduces maternal sensitivity and positive responsiveness to infant cues and bids for
caring attention. Infants perceive these behaviours as stressful which stimulates the
hypothalamic pituitary adrenal axis, triggering cortisol release which, at persistently
elevated levels, inhibits neurogenesis during critical periods of brain development. Elevated
infant cortisol of infants of mothers with PPD may explain later poor child cognitive
development and hyperactivity and anxiety problems into adolescence. The negative
developmental outcomes from poor quality interactions and disrupted cortisol patterns
underscores the urgency for intervening. Treating PPD successfully, has not consistently
improved maternal-infant (M-I) interaction quality and children's development. Parent
training promoting sensitive, responsive interactions may help infants of depressed mothers
develop optimally. Research Question & Objectives: Conduct a randomized controlled trial
(RCT) with depressed mothers of infants aged 2-6 months designed to alter negative M-I
interaction and child development associated with PPD. Objective: examine effect of the
intervention, VID-KIDS ("video-feedback intervention to promote improved interactions between
mothers and their kids"), on: 1) M-I interaction; 2) infant cortisol patterns, infant
development, maternal symptoms of PPD, anxiety, and parenting stress. Anticipate to improve:
1) M-I interactions and infant development, infant cortisol; 2) symptoms of PPD, anxiety,
parenting stress, and infant development. The investigators will conduct cost-benefit
analyses. An additional objective is to collect infant buccal cells for future genetic/
epigenetic analyses. Research has suggested biological sensitivity, assessed via genotyping
specific genetic variants and alleles may confound effects of interventions of this nature.
Intervention may affect the epigenome, particularly the number or nature of methylated DNA
sites, of treated infants differently than untreated infants that may link to infant
development. This portion of the study is optional for parents-they can opt out of buccal
cell collection. Methods: The study will implement a parallel group RCT compared to resource
and referral program (standard care) for mothers with PPD and their infants. After baseline
assessment, over the following 9-weeks, mothers randomized to the intervention will receive
3-video-feedback sessions during home visits conducted at 3-week intervals. Mothers
randomized to the control condition will receive standard care. Both groups will be assessed
at baseline, immediately following the 9-week treatment/standard care interval (post-test),
then 2-months later (delayed post-test). Both control and intervention mothers will have
access to standard care over the study period. Mothers' use of such health services will be
documented. The investigators will adhere to CONSORT guidelines. Intervention description.
Video-feedback interventionists will be trained by Co- PI Tryphonopoulos using a manualized
curriculum of 7-themed modules offered in a 4-day workshop. Training modules will include: 1)
Introduction to Video-feedback; 2) NCAST Keys to Caregiving Program; 3) Infant Engagement and
Disengagement Cues (using NCAST's BabyCues: A Child's First Language Cards®; 4)
Video-feedback Intervention Protocol; 5) Overview of Behaviours of Interest; 6) Case Studies;
and 7) Examples of Strengths-Based Feedback.
The intervention follows an 8-step protocol:
Ice-breaking. Interventionist initiates rapport with the participant. Overview of Infant
Engagement and Disengagement Cues. Using NCAST's BabyCues, interventionists review coloured
photo cards that illustrate and explain the behavioural cues commonly seen in infants,
including potent and subtle engaging and disengaging cues. NCAST Teaching Activity. Using the
Nursing Child Assessment Teaching Scale (NCATS) protocols and elements, mothers are asked to
perform a teaching task more advanced than their infant's age level. Recording Interaction.
Mothers and infants are observed and video-recorded. Initial-Viewing. Specific feedback is
not provided during the initial viewing. Mothers are asked to reflect on and point out any
infant cues they recognize. Interventionist documents the presence or absence of infant cues
and mother's response for later discussion. Second-Viewing. Interventionist and mother
co-view the recorded interaction with opportunities provided for replay/slow review portions
emphasizing sensitivity and responsiveness. Interventionist provides feedback: using praise
reinforcing desired maternal behaviours; information on infant cues; appraisal of maternal
response to infant distress; and use of cognitive growth fostering language. Third-Viewing.
The final viewing, integrates all of the concepts discussed in the previous screenings, using
positive reinforcement to emphasize optimal aspects of sensitivity, responsiveness and
constructive feedback suggesting areas for growth. Post-viewing Debrief. Interventionist and
mother conclude the video-feedback session discussing whatever interests the mother. Mothers
are encouraged to make note their infants' engagement/disengagement cues and responses to
these non-verbal behaviours. Video feedback sessions last 60-90min. Subsequent sessions
follow same protocol (new teaching activities) and build on the previous interaction guidance
discussions.
