Video-Feedback Interaction Guidance for Improving Interactions Between Depressed Mothers and Their Infants ("VID-KIDS")

NCT03052374 | Active Not Recruiting

• 1 other identifier: REB-Ethics ID #: REB16-1811
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Postpartum depression (PPD) is a major public health issue. Known as "the thief that steals motherhood" since symptoms obstruct a mother's capacity for understanding and enjoying her baby, PPD affects approximately 1 in 5 moms. Built via "serve and return" interactions (e.g. baby smiles, mom smiles back), sensitive and responsive exchanges are the foundation for healthy child development but are diminished by PPD, resulting in interactions that place children at risk for behavioural and cognitive problems. Infants perceive PPD as stressful; stressors stimulate the brain's hypothalamic pituitary adrenal axis (HPA) and trigger stress hormone (cortisol) release, which, in turn, negatively affects developing infant brains by decreasing brain volume. Infants' critical periods of brain development are vulnerable to long-term effects of cortisol, explaining some of the problematic developmental outcomes observed in children of depressed mothers. How can the investigators support depressed mothers and their infants? Successfully treating PPD does not always benefit mother-child relationships; however, this research builds on a successful pilot that demonstrated that nurse-guided video feedback improved mother-infant interactions in the context of PPD. By improving interaction quality, depressed mothers may be motivated to engage in more play and, in turn, infants who appear interested and ready to interact are more likely to elicit positive, enjoyable experiences from mothers. Building on the pilot, the investigators will trial the effectiveness of VID-KIDS (Video-Feedback Interaction Guidance for Improving Interactions Between Depressed Mothers and their Infants) on maternal-infant interaction and infant cortisol patterns as well as infant development, maternal symptoms of depression and anxiety, and parenting self-efficacy. If successful, future aims are to 1) integrate VID-KIDS into existing services of Calgary Public Health; and 2) commercialize VID-KIDS for dissemination.

Conditions

Post Partum Depression

Keywords

Video-Feedback Interaction Guidance; Depressed Mothers and their Infants

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 18 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Mothers will receive standard care such as referral to psychotherapy (intervention mothers will have the same access) over the same length of time.

VID-KIDS Intervention Program Group

EXPERIMENTAL

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. Video-feedback 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

VID-KIDS Intervention Program Group

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Must be new mothers suffering from PPD
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.
• If the investigators are able to successfully invite 40% of these mothers, then the investigators project that the investigators will be able to recruit at least 16 participants per month, giving us our sample in 20-24 months. Since the inception rate of PPD is greatest within the first 12 weeks of delivery, screening mothers at these strategic intervals is particularly advantageous. Moreover, Co-I McNeil and Collaborator Philley (Director of Research and Director of Nursing, Calgary Public Health, respectively) have successful experience with this feasible approach. Eligibility will be based on 1) a cut-off of greater than 12 (indicating probable PPD) on the Edinburgh Postnatal Depression Scale (EPDS) 20; and 2) infant aged 2-6 months at baseline. Mothers will not be excluded for taking anti-depressants or using other interventions for PPD (i.e., counseling, psychotherapy). However, mothers who are receiving other parenting services (e.g., Circle of Security program, infant-parent psychotherapy) will be excluded.

Sponsors & Collaborators

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

Study Sites (1)

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 L Letourneau, RN, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nursing

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 14, 2017
• Study Start: May 1, 2017
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2026
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)