Perinatal DepressionPABNCT07607613
Parents and Babies Pilot
A study testing Parents and Babies Virtual Group Intervention and Parents and Babies Hybrid Group Intervention in people with Perinatal Depression and Postpartum Depression (PPD), run by Northwestern University at 1 site in United States.
Trial summary
The goal of this study will be piloting the Parents and Babies perinatal depression prevention intervention to examine its feasibility and acceptability and to obtain preliminary data on its efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal Depression, Postpartum Depression (PPD)
- What is being tested?
- Parents and Babies Virtual Group Intervention and Parents and Babies Hybrid Group Intervention
- 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
- 3 Aug 2026to Apr 2027
- 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
- self-identify as LGBTQ+
- 18 years old or older
- live in the USA or territories
- speak and understand English
- Currently pregnant or within one year of childbirth
- Endorse current mild depressive symptoms or risk factors for postpartum depression
Who cannot join
- Are unable to consent/have impaired decision making capacity
- Have current active suicidal or homicidal ideation, active psychosis, or current mania
- Are currently experiencing a severe depressive episode
- Do not have audio and/or video capacity for attending group sessions remotely.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Leiszle Lapping-Carr, 312- 503-3814, parentsandbabies@northwestern.edu
About this study
Official title: Parents and Babies: Pilot Testing an Inclusive Preventive Postpartum Depression Intervention
The goal of this study will be piloting the Parents and Babies perinatal depression prevention intervention to examine its feasibility and acceptability and to obtain preliminary data on its efficacy. This includes exploring/understanding users' experiences navigating the interventions (e.g., from an implementation perspective) and preliminary evaluations of clinical outcomes, including mental health and minority stress. With data gathered from this pilot study, we will make final adaptations to the Parents and Babies manuals and plan to develop a randomized-control trial to evaluate efficacy of the intervention.
- Conditions
- Perinatal Depression, Postpartum Depression (PPD)
- Being tested
- Parents and Babies Virtual Group Intervention, Parents and Babies Hybrid Group Intervention
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parents and Babies Virtual Group InterventionBehavioural
Parents and Babies is a 10-session intervention adapted from Mothers and Babies, a nationally recognized intervention for depression during pregnancy and postpartum built on principles of cognitive-behavioral therapy (CBT), attachment theory, and psychoeducation. Sessions are delivered virtually and led by a clinical psychologist.
Parents and Babies Hybrid Group InterventionBehavioural
Parents and Babies is a 10-session intervention adapted from Mothers and Babies, a nationally recognized intervention for depression during pregnancy and postpartum built on principles of cognitive-behavioral therapy (CBT), attachment theory, and psychoeducation. Sessions are delivered virtually and led by a clinical psychologist, with an option for in-person participation at three sessions.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Group | Experimental | Sessions will be delivered virtually. Includes participants from across the US. Receives: Behavioral: Parents and Babies Virtual Group Intervention |
| Hybrid Group | Experimental | Sessions will be delivered virtually with three hybrid sessions with options for in-person attendance. Includes only participants located in the Chicagoland area. Receives: Behavioral: Parents and Babies Hybrid Group Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire - 9 (PHQ-9)
The Patient Health Questionnaire-9 is the 9 item depression module of the Patient Health Questionnaire. It scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Higher scores indicate an increased severity of depression symptoms.
Measured: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
Perceived Stress Scale (PSS-10)
The Perceived Stress Scale (PSS-10; Cohen, Kamarch, \& Mermelstein,1983) is a 10 item measure of the degree to which situations in one's life are appraised as stressful with responses rated on a 5-point Likert scale (0 =never to 4 =very often). Higher scores indicate greater perceived stress.
Measured: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
Generalized Anxiety Disorder Scale (GAD-7)
The Generalized Anxiety Disorder Scale (Spitzer et.al, 2006) is a 7 item self-report measure used to assess anxiety. Participants are queried regarding symptoms during the past two weeks and responses are tallied on a four-point Likert scale. (0 = not at all to 3=nearly every day.) Higher scores indicate an increased severity of anxiety symptoms.
Measured: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
Multidimensional Scale of Perceived Social Support (MSPSS)
The Multidimensional Scale of Perceived Social Support (Zimet et al. 1988) is a 12-item measure of perceived adequacy of social support from three sources: family, friends, \& significant other; using a 5-point Likert scale (0 = strongly disagree, 5 = strongly agree). Higher scores in each subscale indicate greater perceived support from that source.
Measured: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
The Acceptability of Intervention Measure (AIM)
The Acceptability of Intervention Measure (Weiner et al., 2017) is a four-item measure of implementation outcomes to determine the extent to which one believes an intervention is appealing and satisfactory on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Higher scores indicate greater perceived acceptability of the intervention.
Measured: T2 (immediately post-intervention)
Intervention Appropriateness Measure (IAM)
Intervention Appropriateness Measure (Weiner et al., 2017) is a four-item measure evaluating the extent to which one believes an intervention is suitable, relevant, compatible, and applicable to one's needs on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Higher scores indicate greater perceived appropriateness of the intervention.
Measured: T2 (immediately post-intervention)
Feasibility of Intervention Measure (FIM)
Feasibility of Intervention Measure (Weiner et al., 2017) is a four-item survey measuring the perceived feasibility of an intervention on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Higher scores indicate greater perceived feasibility of the intervention.
Measured: T2 (immediately post-intervention)
Implementation of Parents and Babies skills
Parents and Babies Skill Utilization Survey - 8 item questionnaire to determine the extent to which one agrees that the PAB course taught skills related to the core modules, was useful, and was easy to understand; using a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree).
Measured: T2 (immediately post-intervention), T3 (3-months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start3 Aug 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be recruited for two groups, with a maximum of eight participants per group. Only participants in the Chicagoland area will be eligible for the hybrid group; participants from across the US will be eligible for the virtual-only group.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Leiszle Rae Lapping-Carr, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607613
- Sponsor's protocol ID
- STU00225523
- Other IDs
- 5K23MD018092-03
- Acronym
- PAB
- Status last verified
- Aug 2026
- First submitted
- 19 May 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents and Babies: Pilot Testing an Inclusive Preventive Postpartum Depression Intervention
- ClinicalTrials.gov ID
- NCT07607613
- Acronym / sponsor ID
- PAB / STU00225523
- Conditions
- Perinatal Depression, Postpartum Depression (PPD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 26 May 2026 (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 study will be piloting the Parents and Babies perinatal depression prevention intervention to examine its feasibility and acceptability and to obtain preliminary data on its efficacy. This includes exploring/understanding users' experiences navigating the interventions (e.g., from an implementation perspective) and preliminary evaluations of clinical outcomes, including mental health and minority stress. With data gathered from this pilot study, we will make final adaptations to the Parents and Babies manuals and plan to develop a randomized-control trial to evaluate efficacy of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be recruited for two groups, with a maximum of eight participants per group. Only participants in the Chicagoland area will be eligible for the hybrid group; participants from across the US will be eligible for the virtual-only group.
| Arm | Type | Receives |
|---|---|---|
| Virtual Group | Experimental | Behavioral: Parents and Babies Virtual Group InterventionSessions will be delivered virtually. Includes participants from across the US. |
| Hybrid Group | Experimental | Behavioral: Parents and Babies Hybrid Group InterventionSessions will be delivered virtually with three hybrid sessions with options for in-person attendance. Includes only participants located in the Chicagoland area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- self-identify as LGBTQ+
- 18 years old or older
- live in the USA or territories
- speak and understand English
- Currently pregnant or within one year of childbirth
Key exclusion criteria (4 listed)
- Are unable to consent/have impaired decision making capacity
- Have current active suicidal or homicidal ideation, active psychosis, or current mania
- Are currently experiencing a severe depressive episode
- Do not have audio and/or video capacity for attending group sessions remotely.
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 |
|---|---|---|
| Parents and Babies Virtual Group InterventionParents and Babies is a 10-session intervention adapted from Mothers and Babies, a nationally recognized intervention for depression during pregnancy and postpartum built on principles of cognitive-behavioral therapy (CBT), attachment theory, and psychoeducation. Sessions are delivered virtually and led by a clinical psychologist. | Behavioural | Virtual Group |
| Parents and Babies Hybrid Group InterventionParents and Babies is a 10-session intervention adapted from Mothers and Babies, a nationally recognized intervention for depression during pregnancy and postpartum built on principles of cognitive-behavioral therapy (CBT), attachment theory, and psychoeducation. Sessions are delivered virtually and led by a clinical psychologist, with an option for in-person participation at three sessions. | Behavioural | Hybrid Group |
Primary outcome
Patient Health Questionnaire - 9 (PHQ-9)
Time frame: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
The Patient Health Questionnaire-9 is the 9 item depression module of the Patient Health Questionnaire. It scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Higher scores indicate an increased severity of depression symptoms.
Perceived Stress Scale (PSS-10)
Time frame: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
The Perceived Stress Scale (PSS-10; Cohen, Kamarch, \& Mermelstein,1983) is a 10 item measure of the degree to which situations in one's life are appraised as stressful with responses rated on a 5-point Likert scale (0 =never to 4 =very often). Higher scores indicate greater perceived stress.
Generalized Anxiety Disorder Scale (GAD-7)
Time frame: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
The Generalized Anxiety Disorder Scale (Spitzer et.al, 2006) is a 7 item self-report measure used to assess anxiety. Participants are queried regarding symptoms during the past two weeks and responses are tallied on a four-point Likert scale. (0 = not at all to 3=nearly every day.) Higher scores indicate an increased severity of anxiety symptoms.
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
The Multidimensional Scale of Perceived Social Support (Zimet et al. 1988) is a 12-item measure of perceived adequacy of social support from three sources: family, friends, \& significant other; using a 5-point Likert scale (0 = strongly disagree, 5 = strongly agree). Higher scores in each subscale indicate greater perceived support from that source.
The Acceptability of Intervention Measure (AIM)
Time frame: T2 (immediately post-intervention)
The Acceptability of Intervention Measure (Weiner et al., 2017) is a four-item measure of implementation outcomes to determine the extent to which one believes an intervention is appealing and satisfactory on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Higher scores indicate greater perceived acceptability of the intervention.
Intervention Appropriateness Measure (IAM)
Time frame: T2 (immediately post-intervention)
Intervention Appropriateness Measure (Weiner et al., 2017) is a four-item measure evaluating the extent to which one believes an intervention is suitable, relevant, compatible, and applicable to one's needs on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Higher scores indicate greater perceived appropriateness of the intervention.
Feasibility of Intervention Measure (FIM)
Time frame: T2 (immediately post-intervention)
Feasibility of Intervention Measure (Weiner et al., 2017) is a four-item survey measuring the perceived feasibility of an intervention on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Higher scores indicate greater perceived feasibility of the intervention.
Implementation of Parents and Babies skills
Time frame: T2 (immediately post-intervention), T3 (3-months post-intervention)
Parents and Babies Skill Utilization Survey - 8 item questionnaire to determine the extent to which one agrees that the PAB course taught skills related to the core modules, was useful, and was easy to understand; using a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree).
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 6 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parents and Babies Virtual Group Intervention and Parents and Babies Hybrid Group Intervention in people with Perinatal Depression and Postpartum Depression (PPD), 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 6 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: looking for participants now, as of the sponsor's last update on 6 Aug 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire - 9 (PHQ-9) (time frame: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)). The study lists 8 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 6 Aug 2026.