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Post Partum DepressionVID-KIDSNCT04818047

Adaptation and Pilot Testing of Web and Mobile Interface for the VID-KIDS Intervention

A study testing VID-KIDS Intervention Program in people with Post Partum Depression, run by University of Calgary at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 16 to 49 years, women only
Conditions the study is for
Post Partum Depression
What is being tested?
VID-KIDS Intervention Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesCanada
Study dates
15 Mar 2021to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 49 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Recruitment will be conducted through Calgary Public Health's immunization program. Public Health RNs routinely screen mothers for PPD during infants' vaccination clinic appointments using the Edinburgh Postnatal Depression Scale (EPDS) at 2, 4, and 6 months of age. EPDS scores>12 are indicative of probable major depression with postpartum onset and make a mother eligible for our study. Approximately 500 mothers per year (40/month) screen >12 on the EPDS. The investigators have agreed to support a part-time Calgary Public Health staff person to review screening records and contact potential participants to determine if they are willing to be contacted by a the VID-KIDS Project Manager for further information about the study. If mothers agree, then the VID-KIDS Project Manager will contact the mother to explain the study, further assess eligibility, and if appropriate conduct the informed consent procedure.

Who cannot join

  • None as long as they meet Inclusion Criteria

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • University of Calgary

    Calgary, Alberta, T2N 1N4

  • Maternal Newborn Child and Youth Strategic Clinical Network

    Calgary, Alberta, T2W 1S7

Other trials in Canada

About this study

Official title: VID-KIDS: Rapid User-Informed Web and Mobile Interface Development, Adaptation and Pilot Testing to Support Children's Mental Health and Development.

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.

Read the 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.

Being tested
VID-KIDS Intervention Program
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
Medical subject headings
Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VID-KIDS Intervention ProgramBehavioural

    Also called NCAST Program

    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.

Study groups in NCT04818047
Study groupRoleWhat they receive
Experimental: VID-KIDS Intervention Program GroupExperimentalExperimental: VID-KIDS Intervention Program Group RN review photos of infant engagement/ disengagement cues. NCAST Teaching Activity, mothers asked to perform task advanced for infant's level, recorded. 1st-View, no feedback, mothers reveal infant cues. RN records infant/mother's response, later discussion. 2nd, RN and mother co-view interaction with time for replay/review parts of sensitivity and responsiveness. RN feedback: praising desired maternal behaviours; information on infant cues; maternal response to infant distress; and use of cognitive growth fostering language. 3rd, all concepts discussed in past views, use positive reinforcement to affirm aspects of sensitivity, useful feedback for areas of growth. Post-Debrief, RN and mother discuss interests of the mother. Mothers encouraged to note infants' engagement/disengagement cues.
Receives: Behavioral: VID-KIDS Intervention Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nursing Child Assessment Satellite Training (NCAST) assessment scale will be used to evaluate Mother-Infant (M-I) interactions

    Using the Nursing Child Assessment Satellite Training (NCAST) assessment scale will be used to evaluate Mother-Infant (M-I) interactions. See Study Detailed Description and Intervention arm for more information on the NCAST Program. Scale range from 0 - 73. A higher score means a better outcome, i.e. higher quality of parent-child interaction.

    Measured: through study completion, an average of 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2021
  2. Study start15 Mar 2021
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04818047
Sponsor's protocol ID
CHREB-Ethics ID #: REB16-1811
Acronym
VID-KIDS
Status last verified
May 2023
First submitted
22 Mar 2021
Last updated
12 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing VID-KIDS Intervention Program in people with Post Partum Depression, run by University of Calgary at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nursing Child Assessment Satellite Training (NCAST) assessment scale will be used to evaluate Mother-Infant (M-I) interactions (time frame: through study completion, an average of 18 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.

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