Depression, PostpartumMInDNCT04998721
A Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care
A study testing Promoting First Relationships-Brief and Perinatal Integrated Care in people with Depression, Postpartum and Efficacy, Self, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to assess the effectiveness of a parenting intervention+usual care compared to usual care on postpartum depression and other mental health and parenting outcomes, as well as the feasibility and acceptability of the parenting intervention. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression, Postpartum, Efficacy, Self, Anxiety
- What is being tested?
- Promoting First Relationships-Brief and Perinatal Integrated Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 7 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking pregnant women between gestational age (GA) 13 - 24 weeks
- ≥ 18 years,
- EPDS score ≥10,
- Ability to send and receive text messages (TM)
Who cannot join
- Severe substance use disorder in the past 6 months (score of 4 or above on the Alcohol Use Disorders Test AUDIT-C or a score of 6 or more on the Drug Abuse Screening Test (DAST).
- Active suicidal ideation as measured by follow up to a positive answer to question 10 on the EPDS.
- Bipolar disorder (Composite International Diagnostic Interview score ≥7) or psychotic disorder (assessed by chart review);
- Multiple gestation (assessed by self-report and medical record);
- Ongoing active treatment with psychotropic medications by mental health specialist (but not a PCP or Obstetrician).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care (MInD)
The purpose of this study is to assess the effectiveness of a parenting intervention+usual care compared to usual care on postpartum depression and other mental health and parenting outcomes, as well as the feasibility and acceptability of the parenting intervention.
Read the detailed description
Eligible and consenting participants will be randomized in a single blind manner (research visitor will be blinded to condition) at a 1:1 ratio to either MInD (parenting intervention and usual integrated care) or usual integrated care in their second trimester of pregnancy. Research assessments will be administered during pregnancy and post-partum.
- Conditions
- Depression, Postpartum, Efficacy, Self, Anxiety
- Being tested
- Promoting First Relationships-Brief, Perinatal Integrated Care
- Medical subject headings
- Depression, Postpartum, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting First Relationships-BriefBehavioural
A brief version of the evidence based Promoting First Relationships (PFR) parenting intervention in which a parent is supported in appropriate interpretation of infant cues and in developing skills to effectively parent an infant. Sessions consist of reflective content (observing and reflecting back to the mother on patterns of dyadic interaction) and informational handouts. Reflective content will be delivered in person, and text messaging protocol will deliver informational content at developmentally appropriate times. PFR-B sessions are delivered in primary care settings beginning in the third trimester and continuing postpartum.
Perinatal Integrated CareBehavioural
Integrated Care (IC) is an integrated care model that is effective in the treatment of perinatal depression. CC provides team driven, population focused, measurement guided and evidence based care to improve access and outcomes, control costs, and increase patient satisfaction.
| Study group | Role | What they receive |
|---|---|---|
| Maternal Infant Dyadic Care | Experimental | Perinatal integrated care and Promoting First Relationships-Brief Receives: Behavioral: Promoting First Relationships-Brief; Behavioral: Perinatal Integrated Care |
| Control | Active comparator | Perinatal integrated care only Receives: Behavioral: Perinatal Integrated Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Perinatal Depression on the PHQ-9
The PHQ-9 is a nine -item self-report depression measure with higher scores indicating increased symptom severity, total score ranging from 0 to 27 and is validated for use in the perinatal period.
Measured: Baseline, 3 Months Postpartum, 6 Months Postpartum
Secondary outcomes (4)
Change From Baseline in Parental Self-Efficacy on the Self-Efficacy in a Nurturing Role (SENR)
The SENR contains 16 items rated on 7-point scales regarding mothers' perceptions of their competence on basic skills required in caring for an infant (e.g., "I feel confident in my role as a parent," "I can soothe my baby easily when he or she is crying or fussing") In the prenatal assessment questions address how women expect to do once their infant is born (e.g., "I look forward to becoming a parent with confidence in my role as a parent," "I expect to be able to soothe my baby easily when he or she is crying or fussing"). Scores on the SENR are obtained by summing individual items to yield a total efficacy score, with higher scores reflecting greater feelings of efficacy. Minimum score is 16 and maximum score is 112.
Measured: Baseline, 3 Months Postpartum, 6 Months Postpartum
Change From Postpartum Baseline in Dyadic Interaction
The Nursing Child Assessment Teaching Scale (NCAST) is an observational measure of the quality of caregiver-child dyadic interaction during a brief teaching activity, assessing caregiver sensitivity, responsiveness, and behaviors that foster the child's social-emotional and cognitive development. The caregiver subscale consists of four caregiver subscales comprising 50 items. Each item is scored dichotomously (0 = behavior not observed; 1 = behavior observed), giving a total caregiver score range of 0-50. Higher scores indicate more favorable caregiver-child interaction, reflecting greater caregiver sensitivity. NCATS is scored by observing a 3 minute videotaped session of mother and child interactive behavior.
Measured: 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum
Change From Baseline in Disability on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
WHODAS 2.0 is a 12 item assessment of overall functioning. The scores assigned to each of the items - "none" (0), "mild" (1) "moderate" (2), "severe" (3) and "extreme" (4) - are summed, total score ranging from 0 to 48.
Higher scores indicate higher disability, that is higher values indicate a worse outcome.
Measured: Baseline, 3 Months Postpartum, 6 Months Postpartum
Change From Postpartum Baseline in Maternal Functioning on the Barkin Index of Maternal Functioning (BIMF)
The BIMF is a 20-item self-report measure for use in the first year postpartum and can assess overall functioning in the context of new motherhood. It measures the functional domains of social support, management, mother-child interaction, infant care, self-care, adjustment, and psychological well-being (of the mother). It is measured only postpartum. A total score is generated from summing the 20 items and ranges from 0 to 120. Higher scores indicate better maternal functioning, a better outcome.
Measured: 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start1 Nov 2022
- Primary completion7 Apr 2025
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Amritha Subray Bhat, University of Washington
- Investigators
- Amritha S Bhat, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998721
- Sponsor's protocol ID
- STUDY00011405
- Other IDs
- 1R34MH124798-01
- Acronym
- MInD
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2021
- Last updated
- 4 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care (MInD)
- ClinicalTrials.gov ID
- NCT04998721
- Acronym / sponsor ID
- MInD / STUDY00011405
- Conditions
- Depression, Postpartum, Efficacy, Self, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Posted 4 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effectiveness of a parenting intervention+usual care compared to usual care on postpartum depression and other mental health and parenting outcomes, as well as the feasibility and acceptability of the parenting intervention.
Detailed description
Eligible and consenting participants will be randomized in a single blind manner (research visitor will be blinded to condition) at a 1:1 ratio to either MInD (parenting intervention and usual integrated care) or usual integrated care in their second trimester of pregnancy. Research assessments will be administered during pregnancy and post-partum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maternal Infant Dyadic Care | Experimental | Behavioral: Promoting First Relationships-Brief, Behavioral: Perinatal Integrated CarePerinatal integrated care and Promoting First Relationships-Brief |
| Control | Active comparator | Behavioral: Perinatal Integrated CarePerinatal integrated care only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English speaking pregnant women between gestational age (GA) 13 - 24 weeks
- ≥ 18 years,
- EPDS score ≥10,
- Ability to send and receive text messages (TM)
Key exclusion criteria (5 listed)
- Severe substance use disorder in the past 6 months (score of 4 or above on the Alcohol Use Disorders Test AUDIT-C or a score of 6 or more on the Drug Abuse Screening Test (DAST).
- Active suicidal ideation as measured by follow up to a positive answer to question 10 on the EPDS.
- Bipolar disorder (Composite International Diagnostic Interview score ≥7) or psychotic disorder (assessed by chart review);
- Multiple gestation (assessed by self-report and medical record);
- Ongoing active treatment with psychotropic medications by mental health specialist (but not a PCP or Obstetrician).
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 |
|---|---|---|
| Promoting First Relationships-BriefA brief version of the evidence based Promoting First Relationships (PFR) parenting intervention in which a parent is supported in appropriate interpretation of infant cues and in developing skills to effectively parent an infant. Sessions consist of reflective content (observing and reflecting back to the mother on patterns of dyadic interaction) and informational handouts. Reflective content will be delivered in person, and text messaging protocol will deliver informational content at developmentally appropriate times. PFR-B sessions are delivered in primary care settings beginning in the third trimester and continuing postpartum. | Behavioural | Maternal Infant Dyadic Care |
| Perinatal Integrated CareIntegrated Care (IC) is an integrated care model that is effective in the treatment of perinatal depression. CC provides team driven, population focused, measurement guided and evidence based care to improve access and outcomes, control costs, and increase patient satisfaction. | Behavioural | Control, Maternal Infant Dyadic Care |
Primary outcome
Change From Baseline in Perinatal Depression on the PHQ-9
Time frame: Baseline, 3 Months Postpartum, 6 Months Postpartum
The PHQ-9 is a nine -item self-report depression measure with higher scores indicating increased symptom severity, total score ranging from 0 to 27 and is validated for use in the perinatal period.
4 secondary outcomes
Change From Baseline in Parental Self-Efficacy on the Self-Efficacy in a Nurturing Role (SENR)
Time frame: Baseline, 3 Months Postpartum, 6 Months Postpartum
Change From Postpartum Baseline in Dyadic Interaction
Time frame: 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum
Change From Baseline in Disability on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
Time frame: Baseline, 3 Months Postpartum, 6 Months Postpartum
Change From Postpartum Baseline in Maternal Functioning on the Barkin Index of Maternal Functioning (BIMF)
Time frame: 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Amritha S Bhat, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promoting First Relationships-Brief and Perinatal Integrated Care in people with Depression, Postpartum and Efficacy, Self, run by University of Washington at 1 site in United States.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 4 Nov 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 4 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Perinatal Depression on the PHQ-9 (time frame: Baseline, 3 Months Postpartum, 6 Months Postpartum). 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 4 Nov 2026.