Maternal DepressionNCT04092010
Improving Preschool Outcomes by Addressing Maternal Depression in Head Start
A study testing Problem-solving education (PSE) and Engagement sessions in people with Maternal Depression, run by Brown University at 1 site in United States.
Trial summary
Within a research network of Head Start centers in Massachusetts, an efficacy trial of a stepped-care intervention (SCI) to address maternal depression, using intervention components that both prevent depression and help those in major depressive episode (MDE) engage with care, will be conducted. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Maternal Depression
- What is being tested?
- Problem-solving education (PSE) and Engagement sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2023to 30 Apr 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mother of a 0 to 5-year-old Head Start child
- Mother speaks English or Spanish
Who cannot join
- Mother with suicidal ideation
- Mother with cognitive limitation
Trial locations and contacts
1 site in 1 country.
About this study
Within a research network of Head Start centers in Massachusetts, an efficacy trial of a stepped-care intervention (SCI) to address maternal depression, using intervention components that both prevent depression and help those in major depressive episode (MDE) engage with care, will be conducted. Both the prevention and engagement components of the model have strong, supportive randomized trial evidence for both their efficacy and safety; but they have yet to be synthesized and tested within a coordinated intervention, applicable to a broad population base. Stepped-care interventions are commonly used in mental health service projects, in which the intensity or type of service is calibrated to the severity of illness.
Read the detailed description
This research study is a community-based efficacy trial (n=388) of a stepped-care model intervention to strengthen the capacity of Head Start to address parental depression and related adversities. Head Start mothers with symptoms of depressed mood or anhedonia, and their Head Start children, are enrolled across 12 Head Start centers.
The research study aims to improve developmental outcomes for Head Start children by delivering stepped care intervention that incorporates depression prevention and linkage to formal mental health care to mothers. Mothers with low baseline depressive symptoms are offered a problem-solving intervention while mothers with greater symptoms are offered engagement sessions to link them to formal mental health services. At each problem-solving session participant's symptoms are assessed and if the symptoms meet pre-specified 'step-up' criteria, they are converted to Engagement sessions.
Over 12 months, the intervention's effect will be assessed on a series of outcome measures for mothers; mechanisms by which maternal depression is theorized to impact young children; and child outcomes.
- Conditions
- Maternal Depression
- Being tested
- Problem-solving education (PSE), Engagement sessions, Usual care
- Keywords
- Stepped care intervention, Problem solving education, Engagement session, Head Start, Preschool children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem-solving education (PSE)Behavioural
PSE will be offered to mothers with low baseline depressive symptoms (the first, preventive step of the SCI). PSE participants will have their symptoms assessed at each session and will convert to Engagement Sessions if they meet pre-specified 'step up' criteria.
Engagement sessionsBehavioural
Engagement sessions will be offered to mothers with greater depressive symptoms to link them to formal mental health services (the second, referral step of the SCI)
Usual careBehavioural
Normal services provided children and their mothers in Head Start
| Study group | Role | What they receive |
|---|---|---|
| Stepped-care intervention (SCI) group | Experimental | In the SCI group, mothers with low baseline depressive symptoms are offered the problem-solving education (PSE) prevention intervention, and mothers with greater depressive symptoms are offered Engagement Sessions. Receives: Behavioral: Problem-solving education (PSE); Behavioral: Engagement sessions |
| Usual care control group | Active comparator | Families in the control group will receive usual Head Start services. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in incident rates of moderate to severe maternal depressive symptoms based on the QIDS
The Quick Inventory of Depressive Symptoms (QIDS) will be used to assess the incidence of moderate to severe depressive symptom episodes, as defined by a QIDS score ≥ 11. The QIDS is a 16 item self-administered instrument with potential responses for each item of 0 to 3. Higher scores are associated with greater depressive symptoms.
Measured: Baseline, 2, 4, 6, 8, 10, 12 months follow-up
Change in the mean maternal depressive symptoms based on the QIDS
The Quick Inventory of Depressive Symptoms will be used to assess depressive symptoms. The QIDS is a 16 item self-administered instrument with potential responses for each item of 0 to 3. Higher scores are associated with greater depressive symptoms. The mean QIDS scores will be calculated for the baseline and each follow up period.
Measured: Baseline, 2, 4, 6, 8, 10, 12 months follow-up
Secondary outcomes (14)
Rate of participants engaged with care based on 1 or more psycho/pharmacotherapy visits or psychiatric medication prescription
The investigators have adapted the services section of the Collaborative Psychiatric Epidemiology Surveys, operationalized into engagement with care. This will be defined as ≥ 1 visit for psychotherapy or pharmacotherapy with a behavioral health specialist (social worker, psychologist, psychiatrist, psychiatric nurse); or a prescription for psychiatric medication from any medical practitioner.
Measured: Baseline, 2, 4, 6, 8, 10, 12 months follow-up
Rate of participants retained in care based on 4 or more psycho/pharmacotherapy visits or psychiatric medication prescription
The investigators have adapted the services section of the Collaborative Psychiatric Epidemiology Surveys, operationalized into retention in care. This will be defined as ≥ 4 visit for psychotherapy or pharmacotherapy with a behavioral health specialist (social worker, psychologist, psychiatrist, psychiatric nurse); or a prescription for psychiatric medication from any medical practitioner.
Measured: 2, 4, 6, 8, 10, 12 months
Rate of participants who received evidence-based care defined by psychotherapy or antidepressant medication prescription
The investigators have adapted the services section of the Collaborative Psychiatric Epidemiology Surveys, operationalized into evidence-based care reflecting either psychotherapy or antidepressant medication.
Measured: 2, 4, 6, 8, 10, 12 months
Rate of participants who received primary-care based services
The investigators have adapted the services section of the Collaborative Psychiatric Epidemiology Surveys, operationalized into primary care-based services.
Measured: 2, 4, 6, 8, 10, 12 months
Burden of illness for depression
The Individual Burden of Illness Index for Depression (IBI-D) is a valid and reliable quality of life (QoL) scale, calculated as a composite of the QIDS, the QoL Enjoyment and Satisfaction Questionnaire, and the Work and Social Adjustment Scale
Measured: baseline; 6, 12 months
Child absenteeism from Head Start
Head Start centers will furnish us with monthly absentee rates for all families that provide explicit permission. These will be analyzed as count data against day of eligible attendance.
Measured: baseline; 6, 12 months
Caregiver-Teacher Report Form
This valid and reliable scale will be filled out by Head Start teachers. It measures emotional reactivity, anxiety/depression, somatic complaints, emotional withdrawal, attention problems, and aggressive behavior.
Measured: baseline; 6, 12 months
Social Skills Improvement System - Rating Scales
This valid and reliable scale will be filled out by Head Start teachers. It assesses social skills and problem behaviors for children at risk of interpersonal difficulties.
Measured: baseline; 6, 12 months
Bracken School Readiness Assessment
This scale assesses 85 foundational concepts, including colors, letters, numbers, size/ comparison, and shapes. Assess effect of intervention on child cognitive functioning and school readiness.
Measured: baseline; 6, 12 months
Perceived Stress
Assess with The Perceived Stress Scale, domains of which include unpredictability, lack of control, burden overload, and stressful circumstances.
Measured: baseline, 4, 8, 12 months
Behavioral Activation for Depression
Assess with The Behavioral Activation for Depression Scale (BADS) includes four affective and functional dimensions: activation, avoidance/rumination, work/school impairment, and social impairment.
Measured: baseline, 4, 8, 12 months
Coping Strategies
Assess with The Brief COPE (Coping Orientation to Problems) which measures 14 different adaptive and problematic coping styles. Will also use problem-focused and avoidant subscales.
Measured: baseline, 4, 8, 12 months
Parent-Child Interaction
Assess with The Dyadic Parent-Child Interaction Coding System (4th Edition).
Measured: baseline, 6, 12 months
Family Conflict
Assess with The 80-item Conflicts and Problem-Solving Scale. Likert scales rate aspects of family conflict known to affect children: 1) number of major and minor conflicts in the past year; 2) family disagreement in 21 areas; 3) frequency of 13 conflict resolution strategies; 4) frequency of 44 conflict tactics.
Measured: Baseline, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start16 Aug 2023
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal DepressionStudies of the same condition, open and under way.
- More trials run by Brown 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Boston Medical Center
- Responsible party
- Sponsor
- Investigators
- Emily Feinberg, ScD CPNP, Principal investigator, Brown UniversityMichael Silverstein, MD, Principal investigator, Brown UniversityAmy Yule, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092010
- Sponsor's protocol ID
- 2022003398
- Other IDs
- 1R01HD092456-01A1
- Status last verified
- Aug 2026
- First submitted
- 13 Sep 2019
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data that underlie the results reported for all primary and secondary outcome measures will be made available (text, tables, figures, and appendices).
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
- Improving Preschool Outcomes by Addressing Maternal Depression in Head Start
- ClinicalTrials.gov ID
- NCT04092010
- Acronym / sponsor ID
- 2022003398
- Conditions
- Maternal Depression
- Keywords
- Stepped care intervention, Problem solving education, Engagement session, Head Start, Preschool children
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 388 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Boston Medical Center
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 17 Sep 2019 (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.
Within a research network of Head Start centers in Massachusetts, an efficacy trial of a stepped-care intervention (SCI) to address maternal depression, using intervention components that both prevent depression and help those in major depressive episode (MDE) engage with care, will be conducted. Both the prevention and engagement components of the model have strong, supportive randomized trial evidence for both their efficacy and safety; but they have yet to be synthesized and tested within a coordinated intervention, applicable to a broad population base. Stepped-care interventions are commonly used in mental health service projects, in which the intensity or type of service is calibrated to the severity of illness.
Detailed description
This research study is a community-based efficacy trial (n=388) of a stepped-care model intervention to strengthen the capacity of Head Start to address parental depression and related adversities. Head Start mothers with symptoms of depressed mood or anhedonia, and their Head Start children, are enrolled across 12 Head Start centers.
The research study aims to improve developmental outcomes for Head Start children by delivering stepped care intervention that incorporates depression prevention and linkage to formal mental health care to mothers. Mothers with low baseline depressive symptoms are offered a problem-solving intervention while mothers with greater symptoms are offered engagement sessions to link them to formal mental health services. At each problem-solving session participant's symptoms are assessed and if the symptoms meet pre-specified 'step-up' criteria, they are converted to Engagement sessions.
Over 12 months, the intervention's effect will be assessed on a series of outcome measures for mothers; mechanisms by which maternal depression is theorized to impact young children; and child outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepped-care intervention (SCI) group | Experimental | Behavioral: Problem-solving education (PSE), Behavioral: Engagement sessionsIn the SCI group, mothers with low baseline depressive symptoms are offered the problem-solving education (PSE) prevention intervention, and mothers with greater depressive symptoms are offered Engagement Sessions. |
| Usual care control group | Active comparator | Behavioral: Usual careFamilies in the control group will receive usual Head Start services. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Mother of a 0 to 5-year-old Head Start child
- Mother speaks English or Spanish
Key exclusion criteria (2 listed)
- Mother with suicidal ideation
- Mother with cognitive limitation
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 |
|---|---|---|
| Problem-solving education (PSE)PSE will be offered to mothers with low baseline depressive symptoms (the first, preventive step of the SCI). PSE participants will have their symptoms assessed at each session and will convert to Engagement Sessions if they meet pre-specified 'step up' criteria. | Behavioural | Stepped-care intervention (SCI) group |
| Engagement sessionsEngagement sessions will be offered to mothers with greater depressive symptoms to link them to formal mental health services (the second, referral step of the SCI) | Behavioural | Stepped-care intervention (SCI) group |
| Usual careNormal services provided children and their mothers in Head Start | Behavioural | Usual care control group |
Primary outcome
Change in incident rates of moderate to severe maternal depressive symptoms based on the QIDS
Time frame: Baseline, 2, 4, 6, 8, 10, 12 months follow-up
The Quick Inventory of Depressive Symptoms (QIDS) will be used to assess the incidence of moderate to severe depressive symptom episodes, as defined by a QIDS score ≥ 11. The QIDS is a 16 item self-administered instrument with potential responses for each item of 0 to 3. Higher scores are associated with greater depressive symptoms.
Change in the mean maternal depressive symptoms based on the QIDS
Time frame: Baseline, 2, 4, 6, 8, 10, 12 months follow-up
The Quick Inventory of Depressive Symptoms will be used to assess depressive symptoms. The QIDS is a 16 item self-administered instrument with potential responses for each item of 0 to 3. Higher scores are associated with greater depressive symptoms. The mean QIDS scores will be calculated for the baseline and each follow up period.
14 secondary outcomes
Rate of participants engaged with care based on 1 or more psycho/pharmacotherapy visits or psychiatric medication prescription
Time frame: Baseline, 2, 4, 6, 8, 10, 12 months follow-up
Rate of participants retained in care based on 4 or more psycho/pharmacotherapy visits or psychiatric medication prescription
Time frame: 2, 4, 6, 8, 10, 12 months
Rate of participants who received evidence-based care defined by psychotherapy or antidepressant medication prescription
Time frame: 2, 4, 6, 8, 10, 12 months
Rate of participants who received primary-care based services
Time frame: 2, 4, 6, 8, 10, 12 months
Burden of illness for depression
Time frame: baseline; 6, 12 months
Child absenteeism from Head Start
Time frame: baseline; 6, 12 months
Caregiver-Teacher Report Form
Time frame: baseline; 6, 12 months
Social Skills Improvement System - Rating Scales
Time frame: baseline; 6, 12 months
Bracken School Readiness Assessment
Time frame: baseline; 6, 12 months
Perceived Stress
Time frame: baseline, 4, 8, 12 months
Behavioral Activation for Depression
Time frame: baseline, 4, 8, 12 months
Coping Strategies
Time frame: baseline, 4, 8, 12 months
Parent-Child Interaction
Time frame: baseline, 6, 12 months
Family Conflict
Time frame: Baseline, 6, 12 months
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: Yes. Deidentified individual participant data that underlie the results reported for all primary and secondary outcome measures will be made available (text, tables, figures, and appendices).
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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.
Emily Feinberg, ScD CPNP principal investigator
Brown University
Michael Silverstein, MD principal investigator
Brown University
Amy Yule, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem-solving education (PSE) and Engagement sessions in people with Maternal Depression, run by Brown 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 2 inclusion and 2 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 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?
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 in incident rates of moderate to severe maternal depressive symptoms based on the QIDS (time frame: Baseline, 2, 4, 6, 8, 10, 12 months follow-up). 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 6 Aug 2026.