Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01HD072069 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tufts Medical Center | OTHER |
| Beth Israel Deaconess Medical Center | OTHER |
| Brigham and Women's Hospital | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Not provided
Not provided
Not provided
Not provided
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.
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:
Secondary aims. Regarding risk mechanisms and child outcomes, the investigators aim to:
Exploratory aims. the investigators will explore the role of a brief set of potential intervention moderators:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Problem Solving Education tailored to NICU | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Silverstein, MD, MPH | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States | ||
| Brigham and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36040801 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
Not provided
Not provided
| NIH |
Not provided
Not provided
Not provided
Not provided
| one year |
| Adherence to recommended NICU follow-up care | We assess the following measures of adherence to NICU follow-up care:
| 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. | 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). | one year |
| Cognitive functioning | We will use the MacArthur-Bates Communicative Development Inventory. | one year |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| D011248 |
| Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |