Perinatal DepressionPPD-ACENCT05795114
Perinatal Depression and Adverse Childhood Experiences: Prevention Trial
A study testing Reach Out, Stand Strong, Essentials for New Mothers (ROSE) Program in people with Perinatal Depression, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the impact of ROSE in individuals with adverse childhood experiences. The main question it aims to answer is, compared to enhanced treatment as usual, does the delivery of ROSE within a collaborative care model improve depressive symptom trajectories and prevent the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal Depression
- What is being tested?
- Reach Out, Stand Strong, Essentials for New Mothers (ROSE) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2023to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years
- At least one prenatal visit at Northwestern Medicine
- Less than 24 weeks gestation
- Non-anomalous pregnancy
- English- or Spanish- speaking
- ACE score ≥ 2
- Singleton gestation
Who cannot join
- Intent to delivery outside of Prentice Women's Hospital
- Active major depressive episode
- Active substance use disorder
- Participation in a study with a competing intervention or outcome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Perinatal Depression in Birthing People With a History of Adverse Childhood Experiences: A Type 2 Effectiveness Implementation Trial
The goal of this clinical trial is to evaluate the impact of ROSE in individuals with adverse childhood experiences. The main question it aims to answer is, compared to enhanced treatment as usual, does the delivery of ROSE within a collaborative care model improve depressive symptom trajectories and prevent the development of perinatal depression.
Participants will be randomized to either enhanced treatment as usual or the ROSE intervention, delivered by a care manager within a perinatal collaborative care program. They will complete self-reported surveys of their depression symptoms every 4 weeks to inform their symptom trajectories. They will also complete clinical interviews to establish any incident diagnoses of a major depressive episode.
Read the detailed description
The salience of early life experiences during the transition to parenthood underscores the risk of perinatal depression for those with childhood adversity. Mitigation of the adverse effects of childhood adversity via prevention of perinatal depression is an essential component of a reproductive justice-focused public health strategy. Whether and how the collaborative care model can be most effectively leveraged to prevent perinatal depression among pregnant people with a history of ACEs is unknown. To answer these questions, investigators propose a randomized clinical trial of trauma-informed interpersonal therapy modeled after the ROSE intervention and embedded within a perinatal collaborative care program utilizing a type 2 hybrid effectiveness-implementation design.
- Conditions
- Perinatal Depression
- Being tested
- Reach Out, Stand Strong, Essentials for New Mothers (ROSE) Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reach Out, Stand Strong, Essentials for New Mothers (ROSE) ProgramBehavioural
A 5-part interpersonal therapy based intervention
| Study group | Role | What they receive |
|---|---|---|
| Enhanced treatment as usual | No intervention | Those randomized to enhanced treatment as usual will receive brief psychoeducation about perinatal depression and the associations between ACEs and perinatal depression. Information about the collaborative care program will be provided. Individuals will be followed with monthly self-reported screens for depression, without any prevention programming for perinatal depression. Those identified to have incident depression symptoms will receive recommendations for treatment within the collaborative care model. |
| ROSE intervention | Experimental | Those randomized to the intervention will be offered 4 prenatal sessions and one postpartum "booster" session guided by the Reach Out, Stand Strong, Essentials for New Mothers (ROSE) program embedded within the collaborative care model. Participants will be followed with monthly self-reported screens for depression, and those identified to have incident depression symptoms will receive treatment within the collaborative care model. Receives: Behavioral: Reach Out, Stand Strong, Essentials for New Mothers (ROSE) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms
Depression symptom trajectories will be measured via Patient Health Questionnaire-9 (PHQ-9) screens administered
Measured: Up to 6 months postpartum
Perinatal depression
Perinatal depression includes any categorical diagnosis of a major depressive episode, assessed using the Longitudinal Interval Follow-Up Examination measured by trained research personnel masked to the intervention
Measured: Up to 6 months postpartum
Secondary outcomes (9)
Anxiety symptoms
Anxiety symptom trajectories will be measured via Generalized Anxiety Disorder-7 (GAD-7) screens administered every 4 weeks from enrollment until 6 months postpartum.
Measured: Up to 6 months postpartum
Generalized anxiety disorder
Generalized anxiety disorder includes any categorical diagnosis of generalized anxiety disorder, assessed using the Longitudinal Interval Follow-Up Examination measured by trained research personnel masked to the intervention in the 3rd trimester, at 3 months postpartum, and at 6 months postpartum.
Measured: Up to 6 months postpartum
Post-traumatic stress disorder
Post-traumatic stress disorder includes any categorical diagnosis of a post-traumatic stress disorder, assessed using the Longitudinal Interval Follow-Up Examination measured by trained research personnel masked to the intervention in the 3rd trimester, at 3 months postpartum, and at 6 months postpartum.
Measured: Up to 6 months postpartum
Perceived stress symptoms
Stress symptom trajectories will be measured via Perceived Stress Scale (PSS) screens administered every 4 weeks from enrollment until 6 months postpartum.
Minimum value: 0
Maximum value: 40
Higher scores indicate a worse outcome
Measured: Up to 6 months postpartum
General self-efficacy
Self-efficacy will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy scale, administered in the 3rd trimester, at 3 months postpartum, and at 6 months postpartum.
Minimum value: 10
Maximum value: 50
Higher scores indicate a better outcome
Measured: Up to 6 months postpartum
Parenting self-efficacy
Parenting self-efficacy will be measured with the Parenting Sense of Competence scale administered in the 3rd trimester, at 3 months postpartum, and at 6 months postpartum.
Minimum value: 17
Maximum value: 102
Higher scores indicate a better outcome
Measured: Up to 6 months postpartum
Breastfeeding self-efficacy scale
Breastfeeding self-efficacy will be measured with the Breastfeeding Self-Efficacy scale administered in the 3rd trimester, at 3 months postpartum, and at 6 months postpartum. Included are individuals who are breastfeeding at each of the assessed time-points.
Minimum value: 14
Maximum value: 70
Higher scores indicate a better outcome
Measured: Up to 6 months postpartum
Attachment in adult relationships
Attachment in adult relationships will be measured with the Experiences in Close Relationships-Revised Questionnaire administered in the 3rd trimester, at 3 months postpartum, and at 6 months postpartum.
Measured: Up to 6 months postpartum
Emotional support
Emotional support will be measured with the PROMIS Emotional Support-Short Form administered in the 3rd trimester, at 3 months postpartum, and at 6 months postpartum.
Measured: Up to 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 posted3 Apr 2023
- Study start20 Jul 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Women and Infants Hospital of Rhode Island
- Responsible party
- Principal investigator, Emily Miller, Women and Infants Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795114
- Sponsor's protocol ID
- STU00217940
- Acronym
- PPD-ACE
- Status last verified
- May 2026
- First submitted
- 10 Mar 2023
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Perinatal Depression in Birthing People With a History of Adverse Childhood Experiences: A Type 2 Effectiveness Implementation Trial
- ClinicalTrials.gov ID
- NCT05795114
- Acronym / sponsor ID
- PPD-ACE / STU00217940
- Conditions
- Perinatal Depression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Women and Infants Hospital of Rhode Island
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 3 Apr 2023 (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.
The goal of this clinical trial is to evaluate the impact of ROSE in individuals with adverse childhood experiences. The main question it aims to answer is, compared to enhanced treatment as usual, does the delivery of ROSE within a collaborative care model improve depressive symptom trajectories and prevent the development of perinatal depression.
Participants will be randomized to either enhanced treatment as usual or the ROSE intervention, delivered by a care manager within a perinatal collaborative care program. They will complete self-reported surveys of their depression symptoms every 4 weeks to inform their symptom trajectories. They will also complete clinical interviews to establish any incident diagnoses of a major depressive episode.
Detailed description
The salience of early life experiences during the transition to parenthood underscores the risk of perinatal depression for those with childhood adversity. Mitigation of the adverse effects of childhood adversity via prevention of perinatal depression is an essential component of a reproductive justice-focused public health strategy. Whether and how the collaborative care model can be most effectively leveraged to prevent perinatal depression among pregnant people with a history of ACEs is unknown. To answer these questions, investigators propose a randomized clinical trial of trauma-informed interpersonal therapy modeled after the ROSE intervention and embedded within a perinatal collaborative care program utilizing a type 2 hybrid effectiveness-implementation design.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced treatment as usual | No intervention | –Those randomized to enhanced treatment as usual will receive brief psychoeducation about perinatal depression and the associations between ACEs and perinatal depression. Information about the collaborative care program will be provided. Individuals will be followed with monthly self-reported screens for depression, without any prevention programming for perinatal depression. Those identified to have incident depression symptoms will receive recommendations for treatment within the collaborative care model. |
| ROSE intervention | Experimental | Behavioral: Reach Out, Stand Strong, Essentials for New Mothers (ROSE) ProgramThose randomized to the intervention will be offered 4 prenatal sessions and one postpartum "booster" session guided by the Reach Out, Stand Strong, Essentials for New Mothers (ROSE) program embedded within the collaborative care model. Participants will be followed with monthly self-reported screens for depression, and those identified to have incident depression symptoms will receive treatment within the collaborative care model. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- At least one prenatal visit at Northwestern Medicine
- Less than 24 weeks gestation
- Non-anomalous pregnancy
- English- or Spanish- speaking
Key exclusion criteria (4 listed)
- Intent to delivery outside of Prentice Women's Hospital
- Active major depressive episode
- Active substance use disorder
- Participation in a study with a competing intervention or outcome
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 |
|---|---|---|
| Reach Out, Stand Strong, Essentials for New Mothers (ROSE) ProgramA 5-part interpersonal therapy based intervention | Behavioural | ROSE intervention |
Primary outcome
Depression symptoms
Time frame: Up to 6 months postpartum
Depression symptom trajectories will be measured via Patient Health Questionnaire-9 (PHQ-9) screens administered
Perinatal depression
Time frame: Up to 6 months postpartum
Perinatal depression includes any categorical diagnosis of a major depressive episode, assessed using the Longitudinal Interval Follow-Up Examination measured by trained research personnel masked to the intervention
9 secondary outcomes
Anxiety symptoms
Time frame: Up to 6 months postpartum
Generalized anxiety disorder
Time frame: Up to 6 months postpartum
Post-traumatic stress disorder
Time frame: Up to 6 months postpartum
Perceived stress symptoms
Time frame: Up to 6 months postpartum
General self-efficacy
Time frame: Up to 6 months postpartum
Parenting self-efficacy
Time frame: Up to 6 months postpartum
Breastfeeding self-efficacy scale
Time frame: Up to 6 months postpartum
Attachment in adult relationships
Time frame: Up to 6 months postpartum
Emotional support
Time frame: Up to 6 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Fathers and Babies (FAB) Research Study
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Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reach Out, Stand Strong, Essentials for New Mothers (ROSE) Program in people with Perinatal Depression, run by Northwestern University 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 7 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 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?
This study is still under way. Results are not available in the source record yet.
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?
Depression symptoms (time frame: Up to 6 months postpartum). The study lists 2 primary outcomes in all. 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 Jul 2026.