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

NCT04818047 | Completed

• 1 other identifier: CHREB-Ethics ID #: REB16-1811
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Post Partum Depression

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

Outcome Measures

Primary Outcomes (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.

  through study completion, an average of 18 weeks

Study Arms (1)

Experimental: VID-KIDS Intervention Program Group

EXPERIMENTAL

Experimental: 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.

Behavioral: VID-KIDS Intervention Program

Interventions

VID-KIDS Intervention Program BEHAVIORAL

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.

Also known as: NCAST Program

Experimental: VID-KIDS Intervention Program Group

Eligibility Criteria

• Age: 16 Years - 49 Years
• Gender Eligibility Details: Must be new mothers suffering from PPD
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Health services: collaborator

Study Sites (2)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Maternal Newborn Child and Youth Strategic Clinical Network

Calgary, Alberta, T2W 1S7, Canada

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Nicole Letourneau

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 26, 2021
• Study Start: March 15, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)