Post Partum DepressionVID-KIDSNCT03052374
Video-Feedback Interaction Guidance for Improving Interactions Between Depressed Mothers and Their Infants ("VID-KIDS")
A study testing VID-KIDS Intervention Program in people with Post Partum Depression, run by University of Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Post Partum Depression
- What is being tested?
- VID-KIDS Intervention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2017to 31 Mar 2026
- 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 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older 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.
- 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.
Who cannot join
- None as long as they meet Inclusion Criteria
Trial locations and contacts
1 site in 1 country.
Canada1 site
Maternal Newborn Child and Youth Strategic Clinical Network
Calgary, Alberta, T2W 1S7
About this study
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.
Read the detailed 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.
- Conditions
- Post Partum Depression
- Being tested
- VID-KIDS Intervention Program
- Keywords
- Video-Feedback Interaction Guidance, Depressed Mothers and their Infants
- 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. 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: VID-KIDS Intervention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
- First posted14 Feb 2017
- Study start1 May 2017
- Primary completion31 Dec 2023
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Principal investigator, Nicole Letourneau, University of Calgary
- Investigators
- Nicole L Letourneau, RN, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052374
- Sponsor's protocol ID
- REB-Ethics ID #: REB16-1811
- Acronym
- VID-KIDS
- Status last verified
- Aug 2024
- First submitted
- 2 Feb 2017
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-Feedback Interaction Guidance for Improving Interactions Between Depressed Mothers and Their Infants ("VID-KIDS")
- ClinicalTrials.gov ID
- NCT03052374
- Acronym / sponsor ID
- VID-KIDS / REB-Ethics ID #: REB16-1811
- Conditions
- Post Partum Depression
- Keywords
- Video-Feedback Interaction Guidance, Depressed Mothers and their Infants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 14 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: VID-KIDS Intervention ProgramRN 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- None as long as they meet Inclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VID-KIDS Intervention ProgramAlso: NCAST ProgramInvestigators 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. | Behavioural | VID-KIDS Intervention Program Group |
Primary outcome
NCAST assessment scale will be used to evaluate Mother-Infant (M-I) interactions
Time frame: through study completion, an average of 18 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole L Letourneau, RN, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
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 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
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 22 Aug 2024.