Adaptation and Pilot Testing of Web and Mobile Interface for the VID-KIDS Intervention
Condition: Post Partum Depression
MeSH terms: Depression, Postpartum
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): VID-KIDS Intervention Program
Intervention type(s): Behavioral
Intervention description(s): Investigators created VID-KIDS for mothers with PPD to improve sensitivity and positive responsiveness towards their infants. Video-feedback has the advantage of being visually concrete yet "distant" because the action and the feedback are not concurrent; this helps mothers maintain an element of objectivity that may minimize guilty feelings associated with potential perceived lack of parenting skills. Videofeedback interventionists are trained by investigators with manualized modules. Including: Introduction to Video-feedback; NCAST Keys to Caregiving Program; Infant Engagement and Disengagement Cues; Video-feedback Intervention Protocol; Overview of Behaviours of Interest; Case Studies; and Examples of Strengths-Based Feedback. VID-KIDS intervention follows an 8-step protocol.
Other intervention name(s): NCAST Program
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: virtual mental health interventions; patient-engaged research; infant/child mental health; implementation science; participatory design methods; integrated knowledge transfer; psychosocial/health behavioural research; health services research; parent-child relationships; children's development