DepressionMBDSNCT07469176
Co-Designing and Evaluating Additional Mothers and Babies Program Content for Expectant and New Parents of Children With Down Syndrome
A study testing Mothers and Babies and Mothers and Babies Down Syndrome in people with Depression, run by Northwestern University at 1 site in United States.
Trial summary
Goal: This R34 study will pilot an adaptation for the Mothers and Babies (MB) program for expectant and new parents of infants with Down syndrome (MBDS). Background: Expectant and new parents of infants with Down syndrome are at high risk for perinatal depression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Mothers and Babies and Mothers and Babies Down Syndrome
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2026to 15 Sep 2028
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Expecting or parenting an infant with Down Syndrome (20 months gestation - 4 months old)
- Speaks and Reads English
- Has access to internet and videoconferencing
Who cannot join
- -active suicidal ideation (indicated on the screener)
- Withdrawal criteria:
- Active suicide ideation indicated on any of the following: endorsement of BDI-II item 9, PHQ-9 item 9; PGS-Diagnosis item 3 Subscale II; statements to research staff); or
- BDI-II total score ranging from 20 - 63 indicating the participant endorses moderate to severe depressive symptoms and has a higher need for mental health services.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Goal: This R34 study will pilot an adaptation for the Mothers and Babies (MB) program for expectant and new parents of infants with Down syndrome (MBDS). Background: Expectant and new parents of infants with Down syndrome are at high risk for perinatal depression. Perinatal depression is both independently, and exponentially associated with long-term adverse neurodevelopmental consequences for infants with Down syndrome. MB is a cognitive-behavioral intervention designed to prevent perinatal depression. MB as one of the two most effective counseling interventions for perinatal depression prevention, with moderate to large effects sizes found across a series of randomized controlled trials (RCTs). However, research suggests that expectant and new parents of children with Down syndrome may have needs that standard MB does not address. Significance: This project will pilot a Down syndrome adaptation to MB, MBDS designed to target mechanisms of grief/loss and social support; and assess whether changes in the target mechanisms are associated with changes in depressive symptoms and parental sensitivity and responsivity to the infant. Innovation: The proposed project is innovative in three ways. First, the investigators plan to conduct the first pilot of a perinatal depression prevention intervention specifically designed for expectant and new parents of infants with Down syndrome. Second, the investigators plan to include fathers, nonbinary, and transgender parents to target symptoms of depression, rather than as simply a support person for maternal depressive symptom reduction. Third, the investigators plan to use a group format to establish cohorts of families of infants with Down syndrome of similar developmental stages. Design: Human-centered design and an open trial will inform a subsequent small randomized controlled clinical pilot to test the feasibility of the study protocol in preparation for a larger randomized controlled trial (RCT). Population: New and expectant parents of infants with Down syndrome. Outcomes: All aspects of the study protocol (e.g., condition allocation, treatment and control condition procedures, data collection, etc.) will be operationalized in preparation for the subsequent RCT. The investigators will assess MBDS effectiveness on target mechanisms of grief/loss and social support; and assess whether changes in the target mechanisms are associated with changes in depressive symptoms and parental sensitivity and responsivity to the infant.
Read the detailed description
SPECIFIC AIMS Down syndrome (Trisomy 21) is the most common genetic condition that causes Intellectual and Developmental Disability (IDD) in the U.S. with about 1 in 600 children born in the U.S. each year. Compared to children with other special health care needs, children with Down syndrome experience negative health outcomes and are twice as likely to have unmet health care and family support needs. Down syndrome can be diagnosed as early as 10 weeks gestation or as late as immediately after birth. Regardless of a pre- or post-natal diagnosis, expectant mothers and parents of infants with Down syndrome are at high risk for perinatal depression.
Perinatal depression is one of the most common complications of pregnancy, affecting over half a million parents in the U.S. each year. Perinatal depression is associated with adverse obstetric and neonatal outcomes, including fetal growth restriction and preterm birth. These complications are responsible for most neonatal morbidity and mortality and can increase negative health outcomes for infants with Down syndrome. In addition, perinatal depression can interfere with infant attachment and brain development, further exacerbating learning and behavioral problems in children with Down syndrome. Thus, mitigation of perinatal depression in expectant mothers and new parents of children with Down syndrome is critical to child development and public health.
Mothers and Babies (MB) is an empirically supported cognitive-behavioral intervention designed to prevent perinatal depression. MB consists of 9 weekly sessions, delivered individually or in a group setting. The United States Preventive Services Task Force recognized MB as one of the two most effective counseling interventions for perinatal depression prevention, with moderate to large effect sizes found across a series of randomized controlled trials (RCTs). However, expectant mothers and new parents of children with Down syndrome have critical needs that standard MB does not address. For example, parents report experiencing overwhelming emotions of grief, loss, and mourning when first learning about their child's Down syndrome diagnosis. As a parent of a child with Down syndrome, one of the MPIs knows that cultivating a strengths-based view of the Down syndrome diagnosis can reduce grief/loss and increase hope for the child's future. Parents of children with Down syndrome may also experience isolation. To combat isolation, parents need to hear about the thriving and supportive Down syndrome community, opportunities for their children to reach their potential, and the community supports available to them. The goal of this application is to adapt MB for expectant mothers and new parents of children with Down syndrome, adding intervention components designed to 1) reduce grief/loss and 2) increase social connection to the Down syndrome community. The investigators plan to co-design the Mothers and Babies Down Syndrome (MBDS) adaptation by adding specific content to reduce grief/loss and increase social support and convening MBDS in a group-based format, led by NADS staff and parent volunteers, and connecting families to larger Down Syndrome community networks.
Aim 1: Adapt MB for parents of infants with Down syndrome using a human-centered design approach. Adaptation will be guided by the Exploration, Preparation, Implementation, and Sustainment (EPIS process model, informed by mixed-methods approaches to engage parents of children with Down Syndrome. The investigators will conduct semi-structured interviews, aided by a pre-interview diary study, with individual parents and parent dyads of children with Down syndrome (N = 12). The investigators will then engage parents in co-design workshops to adapt and refine MB for parents of children with Down syndrome. The investigators will use feedback from Aim 1 to adapt content and assist in developing implementation strategies for the MB Down Syndrome (MBDS) program.
Aim 2: Conduct an open trial to assess feasibility and acceptability of the adapted virtual MBDS intervention with expectant mothers and new parents of children with Down syndrome (N = 12). At 4 time points (Baseline, mid- and post-intervention, and 3-month post intervention) the investigators will assess: 1) Acceptability (e.g., satisfaction, facilitators/barriers to participation, and reasons for not attending sessions); 2) Utility - how useful parents found the program to be, and parents' use of curricular elements; 3) Feasibility (number referred who met eligibility, enroll; time to complete assessments and group sessions; and self-reported feasibility).
Aim 3: Conduct a 3-arm pilot RCT to test feasibility and preliminary effectiveness of the virtual MBDS adaptation, relative to the virtual standard, unadapted MB and usual care, with 60 expectant/new mothers of children with Down syndrome to examine whether the intervention leads to changes in the hypothesized target mechanisms of grief/loss and social support; and assess whether changes in the target mechanisms are associated with changes in depressive symptoms and parental sensitivity and responsivity to the infant.
The goal of this R34 proposal is to adapt an existing evidence-based intervention to prevent perinatal depression for expectant mothers and new parents of children with Down syndrome. Feedback regarding adaptation, feasibility, acceptability, and preliminary metrics of effectiveness will inform the planned larger-scale effectiveness trial. The ultimate goal of this research program is to develop an effective and scalable perinatal depression prevention intervention that could be delivered by parents with lived experience.
- Conditions
- Depression
- Being tested
- Mothers and Babies, Mothers and Babies Down Syndrome
- Keywords
- New/expectant parents, Parents of infants with Down syndrome, pregnant with baby with Down syndrome
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mothers and BabiesBehavioural
The Mother and Babies (MB) Program uses principles of cognitive-behavioral therapy (CBT) and attachment theory to target depressive symptoms and perceived stress during the perinatal period. The 9-session intervention will be delivered in 25-minute virtual, weekly session. Each session has an overall objective and 3 to 4 key topics regarding a core cognitive-behavioral skill. Each session has been scripted and has associated resources and materials, and assigns homework (entitled, a "personal project"). Sessions teach parents to identify healthy and unhealthy thoughts and behaviors, modify unhealthy patterns, develop skills to manage stress, ask for what they need, increase behavioral activation and social support.
Mothers and Babies Down SyndromeBehavioural
The investigators will test new Down syndrome content embedded within the standard Mothers and Babies content. The Mother and Babies (MB) Program uses principles of cognitive-behavioral therapy (CBT) and attachment theory to target depressive symptoms and perceived stress during the perinatal period. The 9-session intervention will be delivered in 25-minute virtual, weekly session. Each session has an overall objective and 3 to 4 key topics regarding a core cognitive-behavioral skill. Each session has been scripted and has associated resources and materials, and assigns homework (entitled, a "personal project"). Sessions teach parents to identify healthy and unhealthy thoughts and behaviors, modify unhealthy patterns, develop skills to manage stress, ask for what they need, increase behavioral activation and social support.
| Study group | Role | What they receive |
|---|---|---|
| Standard Mothers & Babies | Active comparator | The standard 9-session Mother's and Babies intervention Receives: Behavioral: Mothers and Babies; Behavioral: Mothers and Babies Down Syndrome |
| Mothers and Babies Down Syndrome | Experimental | The standard 9-session Mother's and Babies content plus Down Syndrome specific content Receives: Behavioral: Mothers and Babies |
| Treatment as Usuals | No intervention | Parents will receive treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perinatal Grief Scale - Diagnosis
The Perinatal Grief Scale-Diagnosis (PGS-D), the NIH Toolkit Emotion Support Test and NIH Toolkit Instrumental Support Test.31 The PGS-D was adapted from the Perinatal Grief Scale,32 a 33-item self-report measure used to assess the intensity of grief following perinatal loss. The PDGS is a 33-item self-report measure used to assess the intensity of grief following receipt of a diagnosis of Down Syndrome for their infant. Participants are asked to indicate their current level of agreement for each statement. Items are rated on a 5-point Likert type scale (0 = strongly agree to 5 = strongly disagree). A total score is determined by summing the ratings for all items. Total scores range from 33 to 165, with higher scores indicating more intense grief. The PGS also consists of 3 subscales: active grief, difficulty coping, and despair. Each subscale score ranges from 11 to 55.
Measured: Baseline, 5 weeks, 9 weeks, 21 weeks
Beck Depression Inventory - 2
The Beck Depression Inventory - II (BDI-II)33 is a 21-item self-report measure used to assess depressive symptoms in adults. Participants are asked to indicate which statement best describes how they felt during the past two weeks including today. Items are rated on a 4-point scale. A total score is determined by summing the ratings for all items. Total scores range from 0 to 63, with higher scores indicating greater depressive symptoms. Total scores ranging from 0 to 13 indicate minimal depressive symptoms, total scores ranging from 14 to 19 indicate mild depressive symptoms, total scores ranging from 20 to 28 indicate moderate depressive symptoms, and total scores ranging from 29 to 63 indicate severe depressive symptoms. The BDI-II has demonstrated high internal consistency (α = 0.91),34 acceptable test-retest reliability,35 strong convergent validity,33 and strong discriminant validity.
Measured: Baseline, 5 weeks, 9 weeks, 21 weeks
The Emotion Support Test
The Emotion Support Test, as part of the NIH Toolbox Emotion Battery, is an 8-item computer-adaptive self- report measure used to assess the perception that people in one's social network are available to listen to one's problems with empathy, caring, and understanding. Participants are asked to respond to each item on a 5-point Likert type scale (1 = rarely to 4 = always). Raw scores are converted into a T-Score, with higher scores indicating more emotional support. Scores 1 SD or more below the mean (T ≤ 40) indicate low levels of emotional support, and scores 1 SD or more above the mean (T ≥ 60) indicate high levels of emotional support.
Measured: Baseline, 5 weeks, 9 weeks, 21 weeks
The Instrumental Support Test
The Instrumental Support Test, as part of the NIH Toolbox Emotion Battery, is an 8-item computer- adaptive self-report measure used to assess the perception that people in one's social network are available to provide material or functional aid in completing daily tasks if needed. Participants are asked to respond to each item on a 5-point Likert type scale (1 = rarely to 5 = always). Raw scores are converted into a T-Score, with higher scores indicating more reported support. Scores 1 SD or more below the mean (T ≤ 40) indicate low levels of instrumental support, and scores 1 SD or more above the mean (T ≥ 60) indicate high levels of instrumental support.
Measured: Baseline, 5 weeks, 9 weeks, 21 weeks
Secondary outcomes (1)
Nursing Childhood Assessment Satellite Training (NCAST) Parent-Child Interaction (PCI) Feeding Scale
The Nursing Childhood Assessment Satellite Training (NCAST) Parent-Child Interaction (PCI) Feeding Scale is a 76-item observer report measure used to assess caregiver behavior and regulation towards their infant in typical daily interactions. Participants are asked to indicate the occurrence vs. non-occurrence of specific behaviors. Items are rated on a binary scale (0= no, 1 = yes). A total score is determined by summing ratings for all items. Total scores range from 0 to 76, with higher scores indicating more favorable parent-child interaction quality. The NCAST PCI Feeding Scale consists of 5 subscales: sensitivity to cues (scores range from 0 to 16), response to child's distress (scores range from 0 to 11), social-emotional growth fostering (scores range from 0 to 14), cognitive growth fostering (scores range from 0 to 9), clarity of cues (scores range from 0 to 10), and responsiveness to caregiver (scores range from 0 to 13).
Measured: 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start25 Sep 2026 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- Aim 2: Open trial (single-group) Aim 3: RCT (3 arms; original intervention, adapted intervention, materials only)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Heather Risser, Northwestern University
- Investigators
- Heather J Risser, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469176
- Sponsor's protocol ID
- R34MH139788
- Acronym
- MBDS
- Status last verified
- Jul 2026
- First submitted
- 9 Mar 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data Sharing Plan Per the notice specifications, investigators will share data via the National Institute of Mental Health Data Archive (NDA). Investigators will collect demographic data necessary to create a Global Unique Identifier (GUID) according to NIMH guidelines. They will also use NIMH tools to generate and submit relevant data and data dictionaries. The investigators will amend informed consent documents to align with NIMH data sharing processes and plans using plain language. The investigators will establish a process to certify the quality of all data generated, document certification, and review data accuracy after submission to the data sharing platform. The descriptive/raw data will be submitted semi-annually (every January 15 and July 15), and all other data will be submitted after publication, or prior to the end of the grant, whichever occurs first.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-Designing and Evaluating Additional Mothers and Babies Program Content for Expectant and New Parents of Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT07469176
- Acronym / sponsor ID
- MBDS / R34MH139788
- Conditions
- Depression
- Keywords
- New/expectant parents, Parents of infants with Down syndrome, pregnant with baby with Down syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 25 Sep 2026 (estimated)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 13 Mar 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.
Goal: This R34 study will pilot an adaptation for the Mothers and Babies (MB) program for expectant and new parents of infants with Down syndrome (MBDS). Background: Expectant and new parents of infants with Down syndrome are at high risk for perinatal depression. Perinatal depression is both independently, and exponentially associated with long-term adverse neurodevelopmental consequences for infants with Down syndrome. MB is a cognitive-behavioral intervention designed to prevent perinatal depression. MB as one of the two most effective counseling interventions for perinatal depression prevention, with moderate to large effects sizes found across a series of randomized controlled trials (RCTs). However, research suggests that expectant and new parents of children with Down syndrome may have needs that standard MB does not address. Significance: This project will pilot a Down syndrome adaptation to MB, MBDS designed to target mechanisms of grief/loss and social support; and assess whether changes in the target mechanisms are associated with changes in depressive symptoms and parental sensitivity and responsivity to the infant. Innovation: The proposed project is innovative in three ways. First, the investigators plan to conduct the first pilot of a perinatal depression prevention intervention specifically designed for expectant and new parents of infants with Down syndrome. Second, the investigators plan to include fathers, nonbinary, and transgender parents to target symptoms of depression, rather than as simply a support person for maternal depressive symptom reduction. Third, the investigators plan to use a group format to establish cohorts of families of infants with Down syndrome of similar developmental stages. Design: Human-centered design and an open trial will inform a subsequent small randomized controlled clinical pilot to test the feasibility of the study protocol in preparation for a larger randomized controlled trial (RCT). Population: New and expectant parents of infants with Down syndrome. Outcomes: All aspects of the study protocol (e.g., condition allocation, treatment and control condition procedures, data collection, etc.) will be operationalized in preparation for the subsequent RCT. The investigators will assess MBDS effectiveness on target mechanisms of grief/loss and social support; and assess whether changes in the target mechanisms are associated with changes in depressive symptoms and parental sensitivity and responsivity to the infant.
Detailed description
SPECIFIC AIMS Down syndrome (Trisomy 21) is the most common genetic condition that causes Intellectual and Developmental Disability (IDD) in the U.S. with about 1 in 600 children born in the U.S. each year. Compared to children with other special health care needs, children with Down syndrome experience negative health outcomes and are twice as likely to have unmet health care and family support needs. Down syndrome can be diagnosed as early as 10 weeks gestation or as late as immediately after birth. Regardless of a pre- or post-natal diagnosis, expectant mothers and parents of infants with Down syndrome are at high risk for perinatal depression.
Perinatal depression is one of the most common complications of pregnancy, affecting over half a million parents in the U.S. each year. Perinatal depression is associated with adverse obstetric and neonatal outcomes, including fetal growth restriction and preterm birth. These complications are responsible for most neonatal morbidity and mortality and can increase negative health outcomes for infants with Down syndrome. In addition, perinatal depression can interfere with infant attachment and brain development, further exacerbating learning and behavioral problems in children with Down syndrome. Thus, mitigation of perinatal depression in expectant mothers and new parents of children with Down syndrome is critical to child development and public health.
Mothers and Babies (MB) is an empirically supported cognitive-behavioral intervention designed to prevent perinatal depression. MB consists of 9 weekly sessions, delivered individually or in a group setting. The United States Preventive Services Task Force recognized MB as one of the two most effective counseling interventions for perinatal depression prevention, with moderate to large effect sizes found across a series of randomized controlled trials (RCTs). However, expectant mothers and new parents of children with Down syndrome have critical needs that standard MB does not address. For example, parents report experiencing overwhelming emotions of grief, loss, and mourning when first learning about their child's Down syndrome diagnosis. As a parent of a child with Down syndrome, one of the MPIs knows that cultivating a strengths-based view of the Down syndrome diagnosis can reduce grief/loss and increase hope for the child's future. Parents of children with Down syndrome may also experience isolation. To combat isolation, parents need to hear about the thriving and supportive Down syndrome community, opportunities for their children to reach their potential, and the community supports available to them. The goal of this application is to adapt MB for expectant mothers and new parents of children with Down syndrome, adding intervention components designed to 1) reduce grief/loss and 2) increase social connection to the Down syndrome community. The investigators plan to co-design the Mothers and Babies Down Syndrome (MBDS) adaptation by adding specific content to reduce grief/loss and increase social support and convening MBDS in a group-based format, led by NADS staff and parent volunteers, and connecting families to larger Down Syndrome community networks.
Aim 1: Adapt MB for parents of infants with Down syndrome using a human-centered design approach. Adaptation will be guided by the Exploration, Preparation, Implementation, and Sustainment (EPIS process model, informed by mixed-methods approaches to engage parents of children with Down Syndrome. The investigators will conduct semi-structured interviews, aided by a pre-interview diary study, with individual parents and parent dyads of children with Down syndrome (N = 12). The investigators will then engage parents in co-design workshops to adapt and refine MB for parents of children with Down syndrome. The investigators will use feedback from Aim 1 to adapt content and assist in developing implementation strategies for the MB Down Syndrome (MBDS) program.
Aim 2: Conduct an open trial to assess feasibility and acceptability of the adapted virtual MBDS intervention with expectant mothers and new parents of children with Down syndrome (N = 12). At 4 time points (Baseline, mid- and post-intervention, and 3-month post intervention) the investigators will assess: 1) Acceptability (e.g., satisfaction, facilitators/barriers to participation, and reasons for not attending sessions); 2) Utility - how useful parents found the program to be, and parents' use of curricular elements; 3) Feasibility (number referred who met eligibility, enroll; time to complete assessments and group sessions; and self-reported feasibility).
Aim 3: Conduct a 3-arm pilot RCT to test feasibility and preliminary effectiveness of the virtual MBDS adaptation, relative to the virtual standard, unadapted MB and usual care, with 60 expectant/new mothers of children with Down syndrome to examine whether the intervention leads to changes in the hypothesized target mechanisms of grief/loss and social support; and assess whether changes in the target mechanisms are associated with changes in depressive symptoms and parental sensitivity and responsivity to the infant.
The goal of this R34 proposal is to adapt an existing evidence-based intervention to prevent perinatal depression for expectant mothers and new parents of children with Down syndrome. Feedback regarding adaptation, feasibility, acceptability, and preliminary metrics of effectiveness will inform the planned larger-scale effectiveness trial. The ultimate goal of this research program is to develop an effective and scalable perinatal depression prevention intervention that could be delivered by parents with lived experience.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Aim 2: Open trial (single-group) Aim 3: RCT (3 arms; original intervention, adapted intervention, materials only)
| Arm | Type | Receives |
|---|---|---|
| Standard Mothers & Babies | Active comparator | Behavioral: Mothers and Babies, Behavioral: Mothers and Babies Down SyndromeThe standard 9-session Mother's and Babies intervention |
| Mothers and Babies Down Syndrome | Experimental | Behavioral: Mothers and BabiesThe standard 9-session Mother's and Babies content plus Down Syndrome specific content |
| Treatment as Usuals | No intervention | –Parents will receive treatment as Usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Expecting or parenting an infant with Down Syndrome (20 months gestation - 4 months old)
- Speaks and Reads English
- Has access to internet and videoconferencing
Key exclusion criteria (4 listed)
- -active suicidal ideation (indicated on the screener)
- Active suicide ideation indicated on any of the following: endorsement of BDI-II item 9, PHQ-9 item 9; PGS-Diagnosis item 3 Subscale II; statements to research staff); or
- BDI-II total score ranging from 20 - 63 indicating the participant endorses moderate to severe depressive symptoms and has a higher need for mental health services.
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 |
|---|---|---|
| Mothers and BabiesThe Mother and Babies (MB) Program uses principles of cognitive-behavioral therapy (CBT) and attachment theory to target depressive symptoms and perceived stress during the perinatal period. The 9-session intervention will be delivered in 25-minute virtual, weekly session. Each session has an overall objective and 3 to 4 key topics regarding a core cognitive-behavioral skill. Each session has been scripted and has associated resources and materials, and assigns homework (entitled, a "personal project"). Sessions teach parents to identify healthy and unhealthy thoughts and behaviors, modify unhealthy patterns, develop skills to manage stress, ask for what they need, increase behavioral activation and social support. | Behavioural | Mothers and Babies Down Syndrome, Standard Mothers & Babies |
| Mothers and Babies Down SyndromeThe investigators will test new Down syndrome content embedded within the standard Mothers and Babies content. The Mother and Babies (MB) Program uses principles of cognitive-behavioral therapy (CBT) and attachment theory to target depressive symptoms and perceived stress during the perinatal period. The 9-session intervention will be delivered in 25-minute virtual, weekly session. Each session has an overall objective and 3 to 4 key topics regarding a core cognitive-behavioral skill. Each session has been scripted and has associated resources and materials, and assigns homework (entitled, a "personal project"). Sessions teach parents to identify healthy and unhealthy thoughts and behaviors, modify unhealthy patterns, develop skills to manage stress, ask for what they need, increase behavioral activation and social support. | Behavioural | Standard Mothers & Babies |
Primary outcome
Perinatal Grief Scale - Diagnosis
Time frame: Baseline, 5 weeks, 9 weeks, 21 weeks
The Perinatal Grief Scale-Diagnosis (PGS-D), the NIH Toolkit Emotion Support Test and NIH Toolkit Instrumental Support Test.31 The PGS-D was adapted from the Perinatal Grief Scale,32 a 33-item self-report measure used to assess the intensity of grief following perinatal loss. The PDGS is a 33-item self-report measure used to assess the intensity of grief following receipt of a diagnosis of Down Syndrome for their infant. Participants are asked to indicate their current level of agreement for each statement. Items are rated on a 5-point Likert type scale (0 = strongly agree to 5 = strongly disagree). A total score is determined by summing the ratings for all items. Total scores range from 33 to 165, with higher scores indicating more intense grief. The PGS also consists of 3 subscales: active grief, difficulty coping, and despair. Each subscale score ranges from 11 to 55.
Beck Depression Inventory - 2
Time frame: Baseline, 5 weeks, 9 weeks, 21 weeks
The Beck Depression Inventory - II (BDI-II)33 is a 21-item self-report measure used to assess depressive symptoms in adults. Participants are asked to indicate which statement best describes how they felt during the past two weeks including today. Items are rated on a 4-point scale. A total score is determined by summing the ratings for all items. Total scores range from 0 to 63, with higher scores indicating greater depressive symptoms. Total scores ranging from 0 to 13 indicate minimal depressive symptoms, total scores ranging from 14 to 19 indicate mild depressive symptoms, total scores ranging from 20 to 28 indicate moderate depressive symptoms, and total scores ranging from 29 to 63 indicate severe depressive symptoms. The BDI-II has demonstrated high internal consistency (α = 0.91),34 acceptable test-retest reliability,35 strong convergent validity,33 and strong discriminant validity.
The Emotion Support Test
Time frame: Baseline, 5 weeks, 9 weeks, 21 weeks
The Emotion Support Test, as part of the NIH Toolbox Emotion Battery, is an 8-item computer-adaptive self- report measure used to assess the perception that people in one's social network are available to listen to one's problems with empathy, caring, and understanding. Participants are asked to respond to each item on a 5-point Likert type scale (1 = rarely to 4 = always). Raw scores are converted into a T-Score, with higher scores indicating more emotional support. Scores 1 SD or more below the mean (T ≤ 40) indicate low levels of emotional support, and scores 1 SD or more above the mean (T ≥ 60) indicate high levels of emotional support.
The Instrumental Support Test
Time frame: Baseline, 5 weeks, 9 weeks, 21 weeks
The Instrumental Support Test, as part of the NIH Toolbox Emotion Battery, is an 8-item computer- adaptive self-report measure used to assess the perception that people in one's social network are available to provide material or functional aid in completing daily tasks if needed. Participants are asked to respond to each item on a 5-point Likert type scale (1 = rarely to 5 = always). Raw scores are converted into a T-Score, with higher scores indicating more reported support. Scores 1 SD or more below the mean (T ≤ 40) indicate low levels of instrumental support, and scores 1 SD or more above the mean (T ≥ 60) indicate high levels of instrumental support.
1 secondary outcome
Nursing Childhood Assessment Satellite Training (NCAST) Parent-Child Interaction (PCI) Feeding Scale
Time frame: 21 weeks
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 15 Sep 2026.
- Individual participant dataSharing planned: Yes. Data Sharing Plan Per the notice specifications, investigators will share data via the National Institute of Mental Health Data Archive (NDA). Investigators will collect demographic data necessary to create a Global Unique Identifier (GUID) according to NIMH guidelines. They will also use NIMH tools to generate and submit relevant data and data dictionaries. The investigators will amend informed consent documents to align with NIMH data sharing processes and plans using plain language. The investigators will establish a process to certify the quality of all data generated, document certification, and review data accuracy after submission to the data sharing platform. The descriptive/raw data will be submitted semi-annually (every January 15 and July 15), and all other data will be submitted after publication, or prior to the end of the grant, whichever occurs first.
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RecruitingObservational study
Tracking Response to Antidepressants in Advance of Investigational Trials
Major Depressive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
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.
Heather J Risser principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mothers and Babies and Mothers and Babies Down Syndrome in people with 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 4 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: opening soon, as of the sponsor's last update on 15 Sep 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?
Contact Heather Risser, PhD (13128483019, heather.risser@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perinatal Grief Scale - Diagnosis (time frame: Baseline, 5 weeks, 9 weeks, 21 weeks). The study lists 4 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 15 Sep 2026.