DepressionNCT01892982
Improving Preterm Outcomes by Safeguarding Maternal Mental Health
A study testing Problem Solving Education tailored to NICU in people with Depression and Child Development, run by Boston Medical Center at 4 sites in United States.
Trial summary
The investigators' goal is to optimize the developmental outcomes of preterm infants by preventing depression and improving functioning among their mothers during the critical first year of life. Read more about this study
- Who is it for?
- Ages Up to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Child Development
- What is being tested?
- Problem Solving Education tailored to NICU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2013to 31 Jul 2018
- 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 Up to 64 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Baby is 26-34 weeks gestational age
- Baby qualifies to receive Medicaid
- Mother comfortable in English or Spanish
- Singleton or twin gestation
- Baby is expected to survive
Who cannot join
- Mother in major depressive episode or endorses suicidality
- Mother with psychosis or otherwise cognitively limited
- Mother with known active substance use; custody of infant uncertain
- Infant is critically ill
- Triplets or higher number gestation
- Mother who is enrolled in another study receiving the same intervention that we are testing
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boston Medical Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The investigators' goal is to optimize the developmental outcomes of preterm infants by preventing depression and improving functioning among their mothers during the critical first year of life. The investigators are conducting a randomized controlled trial of a replicable, lay-delivered intervention - the basic approach of which is to use an empirically-supported, cognitive behavioral strategy to help mothers solve their unique daily problems and address some of the predictable challenges to parenting a preterm infant.
Read the detailed description
Preterm infants are born at biological risk for poor health and developmental outcomes; and those born to low-income families face additional social risks known to further interfere with healthy child development. In its 2006 report, Preterm Birth, the Institute of Medicine (IOM) stated the public health importance of optimizing the developmental outcomes of preterm infants, and specifically called for novel postnatal intervention strategies to accomplish this goal. Our proposed strategy is based on the premise that preventing maternal depression - and optimizing maternal functioning in specific domains that mediate the relationship between maternal depression and adverse child effects - will ultimately improve the developmental outcomes of this vulnerable child population.
Problem Solving Education (PSE) is a cognitive behavioral strategy that aims to impart recipients with skills to reduce the impact of stress on personal functioning, and thereby prevent depression. The present project is a randomized trial of a 6-session intervention based on PSE. the investigators aim to enroll 325 mother-infant dyads in four NICUs - Boston Medical Center, Tufts Medical Center, Beth Israel Deaconess Medical Center, and Brigham and Womens Hospital. Over 12-months of follow-up, the investigators will assess the effects of PSE on a series of outcome measures for mothers, a series of measures that represent risk mechanisms by which maternal depression is theorized to impact young children, and a series of child functioning measures.
- Primary aims. Regarding outcomes for mothers, the investigators aim to:
- Decrease the incidence of major depressive episode (MDE) and improve depressive symptom trajectories during the first postpartum year; and
- Improve general and parental functioning, as measured by valid and reliable scales.
- Secondary aims. Regarding risk mechanisms and child outcomes, the investigators aim to:
- Improve mothers' sense of mastery, and decrease their caregiver burden and social isolation;
- Improve adherence to evidence-based quality indicators for NICU follow-up care;
- Improve maternal sensitivity and mother-child interaction patterns; and
- Improve infant social engagement, emotionality, and cognitive functioning.
- Exploratory aims. the investigators will explore the role of a brief set of potential intervention moderators:
- On the infant level: severity of infant illness.
- On the maternal and family level: maternal trauma history, extended family functioning, and intervention adherence.
- Conditions
- Depression, Child Development
- Being tested
- Problem Solving Education tailored to NICU
- Keywords
- Maternal Depression, Preterm Birth, Preterm Outcomes, Child Development
- Medical subject headings
- Depression, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving Education tailored to NICUBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Problem Solving Education tailored to NICU | Experimental | NICU-PSE integrates motivational interviewing and problem solving, with ongoing monitoring and linkage to mental health services for mothers with worsening depressive symptoms over time. The intervention is provided over six sessions, including three tailored, post-discharge sessions, which address issues common to families of preterm infants: caregiver burden, complexity of medical follow-up, and social reintegration following hospitalization. Receives: Behavioral: Problem Solving Education tailored to NICU |
| Control | No intervention | Both study groups receive standard NICU medical, social work, and nursing services. At each study site, attending neonatologists and pediatrics residents constitute the medical team, and all families are assigned a social worker. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major depressive episode and depressive symptom trajectories
To measure depression and depressive symptom trajectories, we will combine a dimensional measure (the Quick Inventory of Depressive Symptoms - QIDS) with the diagnostic Structured Clinical Interview for DSM-IV Disorders (SCID). Administering the QIDS every other month during this time frame will allow us to follow depression symptom trajectories with a repeated measure sensitive to change with treatment. Administering the SCID at 12-months will allow us to determine timing and severity of major depressive episode(s).
Measured: one year
General Functioning
General functioning will be measured by the mean total SAS-SR score, and mean scores for the family, partner, and social SAS subscales. The SAS will be administered at 6 and 12 months of follow-up.
Measured: one year
Secondary outcomes (5)
Caregiver burden, mastery and social support
The Coping Health Inventory for Parents is a valid and reliable instrument designed to measure parents' response to managing family life when they have an ill child. It will be administered together with the Pearlin Mastery Scale and the Medical Outcomes Survey Social Support Scale. Administration of these scales will occur at 6 and 12 months of follow-up.
Measured: one year
Adherence to recommended NICU follow-up care
We assess the following measures of adherence to NICU follow-up care:
- timing and receipt of health supervision visits and immunizations following NICU discharge - including Palivizumab (Synagis).
- ratio of complaint-based to preventive primary care visits; evaluation for, and attendance to, early intervention services.
Measured: one year
Parent-child interaction
We will videotape and microcode a 10-minute mother-infant free play session according to the parent, infant, and dyadic scales of the Coding Interactive Behavior Manual (CIB). We will assess the following composites: maternal sensitivity; intrusive and withdrawn maternal interactions; and depressed mood and positive affect.
Measured: one year
Socio-emotional functioning
We will assess the CIB infant social engagement composite. We will assess negative infant emotionality using the 4-minute 'Mask Task' of the Laboratory Temperamental Assessment Battery (Lab-TAB).
Measured: one year
Cognitive functioning
We will use the MacArthur-Bates Communicative Development Inventory.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2013 (estimated)
- Study startJun 2013
- Primary completion25 May 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts Medical Center, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Michael Silverstein, MD, MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892982
- Sponsor's protocol ID
- H-31407
- Other IDs
- R01HD072069
- Status last verified
- Aug 2018
- First submitted
- 2 Jul 2013
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Elansary M, Zuckerman B, Patts G, Antonio J, Mayes LC, Silverstein M. Posttraumatic Stress Symptoms and the Quality of Maternal-Child Interactions in Mothers of Preterm Infants. J Dev Behav Pediatr. 2022 Dec 1;43(9):e605-e613. doi: 10.1097/DBP.0000000000001122. Epub 2022 Aug 29.
PubMed 36040801
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Preterm Outcomes by Safeguarding Maternal Mental Health
- ClinicalTrials.gov ID
- NCT01892982
- Acronym / sponsor ID
- H-31407
- Conditions
- Depression, Child Development
- Keywords
- Maternal Depression, Preterm Birth, Preterm Outcomes, Child Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Tufts Medical Center, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jun 2013
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 8 Jul 2013 (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.
The investigators' goal is to optimize the developmental outcomes of preterm infants by preventing depression and improving functioning among their mothers during the critical first year of life. The investigators are conducting a randomized controlled trial of a replicable, lay-delivered intervention - the basic approach of which is to use an empirically-supported, cognitive behavioral strategy to help mothers solve their unique daily problems and address some of the predictable challenges to parenting a preterm infant.
Detailed description
Preterm infants are born at biological risk for poor health and developmental outcomes; and those born to low-income families face additional social risks known to further interfere with healthy child development. In its 2006 report, Preterm Birth, the Institute of Medicine (IOM) stated the public health importance of optimizing the developmental outcomes of preterm infants, and specifically called for novel postnatal intervention strategies to accomplish this goal. Our proposed strategy is based on the premise that preventing maternal depression - and optimizing maternal functioning in specific domains that mediate the relationship between maternal depression and adverse child effects - will ultimately improve the developmental outcomes of this vulnerable child population.
Problem Solving Education (PSE) is a cognitive behavioral strategy that aims to impart recipients with skills to reduce the impact of stress on personal functioning, and thereby prevent depression. The present project is a randomized trial of a 6-session intervention based on PSE. the investigators aim to enroll 325 mother-infant dyads in four NICUs - Boston Medical Center, Tufts Medical Center, Beth Israel Deaconess Medical Center, and Brigham and Womens Hospital. Over 12-months of follow-up, the investigators will assess the effects of PSE on a series of outcome measures for mothers, a series of measures that represent risk mechanisms by which maternal depression is theorized to impact young children, and a series of child functioning measures.
- Primary aims. Regarding outcomes for mothers, the investigators aim to:
- Decrease the incidence of major depressive episode (MDE) and improve depressive symptom trajectories during the first postpartum year; and
- Improve general and parental functioning, as measured by valid and reliable scales.
- Secondary aims. Regarding risk mechanisms and child outcomes, the investigators aim to:
- Improve mothers' sense of mastery, and decrease their caregiver burden and social isolation;
- Improve adherence to evidence-based quality indicators for NICU follow-up care;
- Improve maternal sensitivity and mother-child interaction patterns; and
- Improve infant social engagement, emotionality, and cognitive functioning.
- Exploratory aims. the investigators will explore the role of a brief set of potential intervention moderators:
- On the infant level: severity of infant illness.
- On the maternal and family level: maternal trauma history, extended family functioning, and intervention adherence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Problem Solving Education tailored to NICU | Experimental | Behavioral: Problem Solving Education tailored to NICUNICU-PSE integrates motivational interviewing and problem solving, with ongoing monitoring and linkage to mental health services for mothers with worsening depressive symptoms over time. The intervention is provided over six sessions, including three tailored, post-discharge sessions, which address issues common to families of preterm infants: caregiver burden, complexity of medical follow-up, and social reintegration following hospitalization. |
| Control | No intervention | –Both study groups receive standard NICU medical, social work, and nursing services. At each study site, attending neonatologists and pediatrics residents constitute the medical team, and all families are assigned a social worker. |
Who may qualify
- Ages
- Up to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Baby is 26-34 weeks gestational age
- Baby qualifies to receive Medicaid
- Mother comfortable in English or Spanish
- Singleton or twin gestation
- Baby is expected to survive
Key exclusion criteria (6 listed)
- Mother in major depressive episode or endorses suicidality
- Mother with psychosis or otherwise cognitively limited
- Mother with known active substance use; custody of infant uncertain
- Infant is critically ill
- Triplets or higher number gestation
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 tailored to NICU | Behavioural | Problem Solving Education tailored to NICU |
Primary outcome
Incidence of major depressive episode and depressive symptom trajectories
Time frame: one year
To measure depression and depressive symptom trajectories, we will combine a dimensional measure (the Quick Inventory of Depressive Symptoms - QIDS) with the diagnostic Structured Clinical Interview for DSM-IV Disorders (SCID). Administering the QIDS every other month during this time frame will allow us to follow depression symptom trajectories with a repeated measure sensitive to change with treatment. Administering the SCID at 12-months will allow us to determine timing and severity of major depressive episode(s).
General Functioning
Time frame: one year
General functioning will be measured by the mean total SAS-SR score, and mean scores for the family, partner, and social SAS subscales. The SAS will be administered at 6 and 12 months of follow-up.
5 secondary outcomes
Caregiver burden, mastery and social support
Time frame: one year
Adherence to recommended NICU follow-up care
Time frame: one year
Parent-child interaction
Time frame: one year
Socio-emotional functioning
Time frame: one year
Cognitive functioning
Time frame: one year
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 2018.
- Derived from this study: PubMed 36040801Elansary M, Zuckerman B, Patts G, Antonio J, Mayes LC, Silverstein M. Posttraumatic Stress Symptoms and the Quality of Maternal-Child Interactions in Mothers of Preterm Infants. J Dev Behav Pediatr. 2022 Dec 1;43(9):e605-e613. doi: 10.1097/DBP.0000000000001122. Epub 2022 Aug 29.
- 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. This study is not recruiting at the moment.
Michael Silverstein, MD, MPH principal investigator
Boston Medical Center
4 sites 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 tailored to NICU in people with Depression and Child Development, 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 5 inclusion and 6 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 2018. 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?
Incidence of major depressive episode and depressive symptom trajectories (time frame: one year). 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?
On the ClinicalTrials.gov record for NCT01892982, which also lists 1 linked publication.
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 2018.