Maternal DepressionNCT01182363
Reducing Risk After an Adverse Pregnancy Outcome
A study testing Project Solve Education in people with Maternal Depression, run by Boston Medical Center at 4 sites in United States.
Trial summary
This application to the Boston University Medical Center Institutional Review Board outlines a research plan devoted to identifying and managing maternal depression in Early Intervention (EI). Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Depression
- What is being tested?
- Project Solve Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2010to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mothers of children with a child < or equal to 18 months of age
- Mothers who speaks English or Spanish
- Mothers of children who receive early intervention services for a condition related to an adverse pregnancy outcome (gestational age less than 37 weeks, birth weight less than 2500 grams, congenital, genetic or other condition expected to result in chronic health condition or developmental delay, Neonatal Intensive Care Unit admission great than 5 days, Apgar of 5 at 5 minutes).
- Mother meets depression risk criteria in 2/4 areas of risk (current depressive symptoms, risk factors for depressive illness, social risk, limited financial resources).
Who cannot join
- Women whose children are not currently enrolled in early intervention.
- Lack capacity to understand study procedures and provide consent
- Plan to relocate to another geographic region within 6 months
- Current psychosis
- Active suicidal ideation
- Diagnosis of schizophrenia.
- Mother actively using illicit drugs.
- Child's adverse birth outcome is not expected to result in chronic health condition or developmental delay.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Bay Cove Early Intervention
Boston, Massachusetts, 02114
THOM Child and Family Services
Natick, Massachusetts, 01760
Meeting Street
Providence, Rhode Island, 02905
South Shore Mental Health Step One Early Intervention
Quincy, Massachusetts, 02169
About this study
Official title: Reducing Risk After an Adverse Pregnancy Outcome: Addressing Maternal Depression During Internatal Periods
This application to the Boston University Medical Center Institutional Review Board outlines a research plan devoted to identifying and managing maternal depression in Early Intervention (EI). The target population is women who's children are enrolled in early intervention who have experienced an adverse pregnancy outcome, defined as the birth of a child who was born prematurely, low birth weight, or with birth defects. Early intervention provides developmental services to the state's birth to three population under the Part C of the Individuals with Disabilities Act (IDEA). Our intervention strategy involves the identification of mothers whose children receive early intervention services and who, themselves, are at risk for depression. Eligible mothers will be offered a preventative intervention that involves the principles of Problem Solving Treatment (PST). Problem Solving Treatment is a brief skills-building psychotherapeutic intervention that focuses on specific daily problems, and applies to these problems a structured approach to finding and evaluating solutions.
This study will be a parallel group randomized control trial (RCT) of 188 mother-child dyads. Mothers in the intervention group will receive 6 sessions of Problem Solving Treatment, which will be referred to as Problem Solving Education (PSE) in this application. The women in the control site will receive usual care. Problem Solving Education interventionists (Problem Solving Educators or PS Educators) will conduct Problem Solving Education with mothers of children who receive early intervention services through Thom Child and Family Services, Bay Cove Early Intervention program, South Shore Mental Health (Step One Early Intervention), and Meeting Street Early Intervention with an enrollment goal of 188 mothers. In addition to engaging in Problem Solving Education sessions, mothers who agree to participate in the study will meet with research staff to complete 1)baseline assessment measures at study enrollment and 2) outcome assessment measures 3 months after baseline assessment and 3) outcome assessment measures 6 months after baseline assessment.
Read the detailed description
Community-based programs that target vulnerable families consistently identify maternal depression as a factor that negatively impacts maternal and child outcomes. A population in particular need of mental health interventions are mothers of children with who have experienced an adverse pregnancy outcome, defined as the birth of a child who was born prematurely, low birth weight, or with birth defects, a group with increased incidence of depression. Children of depressed mothers are at risk for a vast range of poor physical, cognitive, and emotional problems. Children who have existing underlying developmental concerns due to adverse birth circumstances are especially vulnerable. Therefore, identifying at-risk mothers and intervening to prevent the onset or re-occurrence of depression represents an opportunity not only to help the women affected, but also to improve developmental and behavioral outcomes for their children. Children under 3 with conditions that impact their developmental trajectories receive services through federally mandated Early Intervention (EI) programs; thus early intervention is an important, but underutilized, setting for identification and intervention with at-risk mothers. While effective preventative psychosocial treatments for depression exist, none have been delivered and evaluated in the context of a home-based program specifically for mothers of infants and children with developmental and other chronic health conditions.
The demographics of early intervention families suggest that mothers of enrolled children are at risk for depressive illness. Families are poorer (1 in 4 received welfare payments in the past year), mothers less well educated, and African-Americans are overrepresented (21% vs. 14% of general population), reflecting known risk factors for depression. Almost half of the infants who enter early intervention in the first year of life, the target group for the proposed intervention, are low birth weight (LBW) and have significantly higher levels of demographic risk factors than their normal birth weight peers. Numerous studies have documented elevated incidence of depression among mothers of early born infants. The youngest early intervention enrollees are also more likely to have identified disabilities or conditions, such as cerebral palsy and requirements for assistive technologies that have also been associated with higher rates of maternal depressive symptoms
Strong problem-solving abilities serve as important buffers against the negative impact of life stressors; whereas limited problem solving skills have been linked to the cause and persistence of psychological disorders. Problem solving approaches to depression prevention and treatment are rooted in research that has demonstrated that minor life events or problems are highly correlated with psychological distress, in general, and with depression, specifically. Problem solving interventions that promote skill building have demonstrated effectiveness in reducing behavioral risk, including depression, in a number of settings. Problem solving education (PSE), a brief skills-building psychotherapeutic intervention that focuses on specific daily problems, and applies to these problems a structured approach to finding and evaluating solutions, is one such problem solving approach. Problem solving education differs from other problem solving interventions in that it can be conducted by a variety of health providers, who do not have specific training as mental health clinicians. Sessions are fairly brief (approximately 30 minutes in length) and positive, sustained effects have been achieved in 6-8 sessions. Problem solving education's success is based on premise that strong problem solving abilities promote a sense of control and self-efficacy and buffer the negative effects of life stressors.
The effectiveness of Problem solving education has been well documented in reducing depressive symptoms and increasing function among patients with major depression and possibly minor depression and dysthymia. We propose a research plan that involves delivering Problem solving education to at risk mothers to (i) directly reduce symptom burden among mothers with depressive symptoms, and (ii) facilitate access to further mental health services.
- Conditions
- Maternal Depression
- Being tested
- Project Solve Education
- Keywords
- maternal depression, prematurity, early intervention, developmental delay
- Medical subject headings
- Premature Birth, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project Solve EducationBehavioural
Problem solving education (PSE), a brief skills-building psychotherapeutic intervention that focuses on specific daily problems, and applies to these problems a structured approach to finding and evaluating solutions, is one such problem solving approach. Problem solving education differs from other problem solving interventions in that it can be conducted by a variety of health providers, who do not have specific training as mental health clinicians. Sessions are fairly brief (approximately 30 minutes in length) and positive, sustained effects have been achieved in 6-8 sessions. Problem solving education's success is based on premise that strong problem solving abilities promote a sense of control and self-efficacy and buffer the negative effects of life stressors.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual early intervention services |
| Problem Solving Education | Experimental | Not described Receives: Behavioral: Project Solve Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Inventory of Depressive Symptomology
Measured: Baseline
Secondary outcomes (4)
Parent Stress Index
Measured: Baseline
Social Adjustment Scale - Self-report (SAS- SR)
Measured: Baseline
Perceived Stress Scale
Measured: Baseline
Social Problem Solving Inventory
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2014
- Study completionJan 2014
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.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Feinberg, ScD CPNP, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182363
- Sponsor's protocol ID
- H28906
- Status last verified
- Aug 2014
- First submitted
- 28 Jul 2010
- Last updated
- 28 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Risk After an Adverse Pregnancy Outcome: Addressing Maternal Depression During Internatal Periods
- ClinicalTrials.gov ID
- NCT01182363
- Acronym / sponsor ID
- H28906
- Conditions
- Maternal Depression
- Keywords
- maternal depression, prematurity, early intervention, developmental delay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 16 Aug 2010 (estimated)
- 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.
This application to the Boston University Medical Center Institutional Review Board outlines a research plan devoted to identifying and managing maternal depression in Early Intervention (EI). The target population is women who's children are enrolled in early intervention who have experienced an adverse pregnancy outcome, defined as the birth of a child who was born prematurely, low birth weight, or with birth defects. Early intervention provides developmental services to the state's birth to three population under the Part C of the Individuals with Disabilities Act (IDEA). Our intervention strategy involves the identification of mothers whose children receive early intervention services and who, themselves, are at risk for depression. Eligible mothers will be offered a preventative intervention that involves the principles of Problem Solving Treatment (PST). Problem Solving Treatment is a brief skills-building psychotherapeutic intervention that focuses on specific daily problems, and applies to these problems a structured approach to finding and evaluating solutions.
This study will be a parallel group randomized control trial (RCT) of 188 mother-child dyads. Mothers in the intervention group will receive 6 sessions of Problem Solving Treatment, which will be referred to as Problem Solving Education (PSE) in this application. The women in the control site will receive usual care. Problem Solving Education interventionists (Problem Solving Educators or PS Educators) will conduct Problem Solving Education with mothers of children who receive early intervention services through Thom Child and Family Services, Bay Cove Early Intervention program, South Shore Mental Health (Step One Early Intervention), and Meeting Street Early Intervention with an enrollment goal of 188 mothers. In addition to engaging in Problem Solving Education sessions, mothers who agree to participate in the study will meet with research staff to complete 1)baseline assessment measures at study enrollment and 2) outcome assessment measures 3 months after baseline assessment and 3) outcome assessment measures 6 months after baseline assessment.
Detailed description
Community-based programs that target vulnerable families consistently identify maternal depression as a factor that negatively impacts maternal and child outcomes. A population in particular need of mental health interventions are mothers of children with who have experienced an adverse pregnancy outcome, defined as the birth of a child who was born prematurely, low birth weight, or with birth defects, a group with increased incidence of depression. Children of depressed mothers are at risk for a vast range of poor physical, cognitive, and emotional problems. Children who have existing underlying developmental concerns due to adverse birth circumstances are especially vulnerable. Therefore, identifying at-risk mothers and intervening to prevent the onset or re-occurrence of depression represents an opportunity not only to help the women affected, but also to improve developmental and behavioral outcomes for their children. Children under 3 with conditions that impact their developmental trajectories receive services through federally mandated Early Intervention (EI) programs; thus early intervention is an important, but underutilized, setting for identification and intervention with at-risk mothers. While effective preventative psychosocial treatments for depression exist, none have been delivered and evaluated in the context of a home-based program specifically for mothers of infants and children with developmental and other chronic health conditions.
The demographics of early intervention families suggest that mothers of enrolled children are at risk for depressive illness. Families are poorer (1 in 4 received welfare payments in the past year), mothers less well educated, and African-Americans are overrepresented (21% vs. 14% of general population), reflecting known risk factors for depression. Almost half of the infants who enter early intervention in the first year of life, the target group for the proposed intervention, are low birth weight (LBW) and have significantly higher levels of demographic risk factors than their normal birth weight peers. Numerous studies have documented elevated incidence of depression among mothers of early born infants. The youngest early intervention enrollees are also more likely to have identified disabilities or conditions, such as cerebral palsy and requirements for assistive technologies that have also been associated with higher rates of maternal depressive symptoms
Strong problem-solving abilities serve as important buffers against the negative impact of life stressors; whereas limited problem solving skills have been linked to the cause and persistence of psychological disorders. Problem solving approaches to depression prevention and treatment are rooted in research that has demonstrated that minor life events or problems are highly correlated with psychological distress, in general, and with depression, specifically. Problem solving interventions that promote skill building have demonstrated effectiveness in reducing behavioral risk, including depression, in a number of settings. Problem solving education (PSE), a brief skills-building psychotherapeutic intervention that focuses on specific daily problems, and applies to these problems a structured approach to finding and evaluating solutions, is one such problem solving approach. Problem solving education differs from other problem solving interventions in that it can be conducted by a variety of health providers, who do not have specific training as mental health clinicians. Sessions are fairly brief (approximately 30 minutes in length) and positive, sustained effects have been achieved in 6-8 sessions. Problem solving education's success is based on premise that strong problem solving abilities promote a sense of control and self-efficacy and buffer the negative effects of life stressors.
The effectiveness of Problem solving education has been well documented in reducing depressive symptoms and increasing function among patients with major depression and possibly minor depression and dysthymia. We propose a research plan that involves delivering Problem solving education to at risk mothers to (i) directly reduce symptom burden among mothers with depressive symptoms, and (ii) facilitate access to further mental health services.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual early intervention services |
| Problem Solving Education | Experimental | Behavioral: Project Solve Education |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Mothers of children with a child < or equal to 18 months of age
- Mothers who speaks English or Spanish
- Mothers of children who receive early intervention services for a condition related to an adverse pregnancy outcome (gestational age less than 37 weeks, birth weight less than 2500 grams, congenital, genetic or other condition expected to result in chronic health condition or developmental delay, Neonatal Intensive Care Unit admission great than 5 days, Apgar of 5 at 5 minutes).
- Mother meets depression risk criteria in 2/4 areas of risk (current depressive symptoms, risk factors for depressive illness, social risk, limited financial resources).
Key exclusion criteria (8 listed)
- Women whose children are not currently enrolled in early intervention.
- Lack capacity to understand study procedures and provide consent
- Plan to relocate to another geographic region within 6 months
- Current psychosis
- Active suicidal ideation
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 |
|---|---|---|
| Project Solve EducationProblem solving education (PSE), a brief skills-building psychotherapeutic intervention that focuses on specific daily problems, and applies to these problems a structured approach to finding and evaluating solutions, is one such problem solving approach. Problem solving education differs from other problem solving interventions in that it can be conducted by a variety of health providers, who do not have specific training as mental health clinicians. Sessions are fairly brief (approximately 30 minutes in length) and positive, sustained effects have been achieved in 6-8 sessions. Problem solving education's success is based on premise that strong problem solving abilities promote a sense of control and self-efficacy and buffer the negative effects of life stressors. | Behavioural | Problem Solving Education |
Primary outcome
Quick Inventory of Depressive Symptomology
Time frame: Baseline
4 secondary outcomes
Parent Stress Index
Time frame: Baseline
Social Adjustment Scale - Self-report (SAS- SR)
Time frame: Baseline
Perceived Stress Scale
Time frame: Baseline
Social Problem Solving Inventory
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2014.
Related trials for Maternal Depression
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruiting
Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
Inflammation, Depression Disorder
Recruiting
Methyl Donor-Rich Diet in the Postpartum Period
Postpartum Depression (PPD), Breastfeeding
Active, not recruiting
Improving Maternal Mental Health & SUD Screening and Treatment
Mental Health Issue, Substance Use Disorders
Recruiting
Mother-infant Bonding in the Brain: a Mindfulness-based Intervention
Postpartum Depression, Postpartum 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. This study is not recruiting at the moment.
Emily Feinberg, ScD CPNP principal investigator
Boston University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Solve Education in people with Maternal Depression, run by Boston Medical Center at 4 sites 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 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quick Inventory of Depressive Symptomology (time frame: Baseline). 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 28 Aug 2014.