Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03052374 |
| Other study ID # |
REB-Ethics ID #: REB16-1811 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2017 |
| Est. completion date |
March 31, 2024 |
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
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.
Description:
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.
