Video-Feedback Interaction Guidance for Postpartum Depression

(VID-KIDS Trial)

Overseen By Nicole L Letourneau, RN, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Calgary

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 9 weeks

400 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications, including anti-depressants or other interventions for postpartum depression.

What data supports the effectiveness of the VID-KIDS Intervention Program treatment for postpartum depression?

Research shows that interactive coaching interventions can help improve the connection between mothers with postpartum depression and their babies, which is similar to the goals of the VID-KIDS program. Additionally, various psychosocial and psychological interventions have been found effective in reducing postpartum depression, suggesting that similar approaches like VID-KIDS could also be beneficial. ^{1 2 3 4 5}

How is the VID-KIDS Intervention Program treatment different from other treatments for postpartum depression?

The VID-KIDS Intervention Program is unique because it uses video feedback to help mothers with postpartum depression improve their interactions with their babies. This approach allows mothers to see and reflect on their behavior, which can help change their self-image and enhance their parenting skills, unlike traditional treatments that may not use visual feedback. ^{1 6 7 8 9}

Research Team

Nicole L Letourneau, RN, PhD

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for mothers with postpartum depression, indicated by a score greater than 12 on the Edinburgh Postnatal Depression Scale, and who have infants aged 2-6 months. Mothers taking antidepressants or undergoing other PPD treatments can join, but not those receiving certain other parenting services.

Inclusion Criteria

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.

I scored over 12 on the EPDS and my baby is 2-6 months old.

Exclusion Criteria

None as long as they meet Inclusion Criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of mothers and infants before intervention begins

1 week

Treatment

Mothers receive 3 video-feedback sessions during home visits at 3-week intervals

9 weeks

3 visits (in-person)

Post-test Assessment

Assessment immediately following the 9-week treatment/standard care interval

1 week

Follow-up

Participants are monitored for changes in mother-infant interactions and infant cortisol patterns

8 weeks

Treatment Details

Interventions

• VID-KIDS Intervention Program

Trial Overview The VID-KIDS program aims to improve interactions between depressed mothers and their infants. It uses nurse-guided video feedback to enhance mother-infant exchanges which are crucial for healthy child development and may reduce stress hormone effects in infants.

Participant Groups

Group I: VID-KIDS Intervention Program Group Experimental Treatment 1 Intervention

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.

Group II: Control Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Findings from Research

The ROSE postpartum depression prevention program will be tested on 2320 pregnant individuals to evaluate its effectiveness as a universal prevention strategy, compared to selective or indicated prevention methods.

This study aims to provide insights into the cost-effectiveness, equity, and scalability of the ROSE program, making it the largest trial of its kind to date, which could influence future guidelines on postpartum depression prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for the ROSE Scale-Up Study: Informing a decision about ROSE as universal postpartum depression prevention. Johnson, JE., Loree, AM., Sikorskii, A., et al.[2023]

An interactive coaching intervention significantly improved maternal-infant responsiveness among 117 postpartum women, indicating its effectiveness in enhancing mother-infant interactions.

While the intervention did not reduce postpartum depressive symptoms, both treatment and control groups showed improvements in responsiveness and a decrease in depression scores over time, suggesting that factors beyond the intervention may contribute to these changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting responsiveness between mothers with depressive symptoms and their infants. Horowitz, JA., Bell, M., Trybulski, J., et al.[2019]

A pilot study developed and tested a postpartum depression (PPD) screening protocol in safety-net pediatric practices, resulting in an increase in screening rates from 75% to 85% and follow-up documentation from 66% to 87% over three months.

Despite the successful implementation of the protocol, only 6.5% of women screened positive for PPD, indicating a need for further adaptations to improve the effectiveness of screening in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and pilot testing of an adaptable protocol to address postpartum depression in pediatric practices serving lower-income and racial/ethnic minority families: contextual considerations. Goff, SL., Moran, MJ., Szegda, K., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Study protocol for the ROSE Scale-Up Study: Informing a decision about ROSE as universal postpartum depression prevention. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Promoting responsiveness between mothers with depressive symptoms and their infants. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Psychosocial and psychological interventions for prevention of postnatal depression: systematic review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Internet-based interventions for postpartum depression: A systematic review and meta-analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Development and pilot testing of an adaptable protocol to address postpartum depression in pediatric practices serving lower-income and racial/ethnic minority families: contextual considerations. [2022]

6. Austria pubmed.ncbi.nlm.nih.gov

Use of video feedback intervention in an inpatient perinatal psychiatric setting to improve maternal parenting. [2016]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Responding to women's needs and preferences in an online program to prevent postpartum depression. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Social Media-based Parenting Program for Women With Postpartum Depressive Symptoms: An RCT. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Video interaction guidance offered to mothers with postnatal depression: experiences from a pilot study. [2015]