Maternal Depression Clinical Trial
Official title:
Improving Preschool Outcomes by Addressing Maternal Depression in Head Start
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT03955718 -
Developing and Testing Motherly App: a Smartphone Application to Promote Mothers' Mental Health
|
N/A | |
| Recruiting |
NCT04443855 -
WASH Benefits Child Development Follow up
|
N/A | |
| Completed |
NCT02145273 -
Healthy Moms-Healthy Kids: Reducing Maternal Depression for Better Outcomes in Head Start Children
|
N/A | |
| Completed |
NCT01021384 -
Supporting the Well Being of Families of Young Children With Autism Spectrum Disorders
|
Phase 3 | |
| Enrolling by invitation |
NCT04639557 -
Building Regulation in Dual Generations - Telehealth Model
|
N/A | |
| Recruiting |
NCT05959538 -
Building Regulation in Dual Generations 2022-2025
|
N/A | |
| Completed |
NCT01214967 -
Problem Solving Education and Neonatal Intensive Care Unit (NICU) Mothers
|
N/A | |
| Completed |
NCT01238614 -
Universal Screening for Maternal Depression With the CHICA System
|
N/A | |
| Recruiting |
NCT04772677 -
Building Emotional Awareness and Mental Health
|
N/A | |
| Completed |
NCT02644902 -
Technology Assisted Cascade Training and Supervision of Community Health Workers for Thinking Healthy Programme
|
N/A | |
| Completed |
NCT02310529 -
Interpersonal Psychotherapy for Maternal Depression
|
N/A | |
| Recruiting |
NCT05096611 -
Attachment and Biobehavioral Catch-up and Depression Treatment
|
N/A | |
| Completed |
NCT02526355 -
Development and Assessment of a Mobile Phone Based Intervention to Reduce Maternal Depression and Improve Child Health
|
N/A | |
| Completed |
NCT04966312 -
Preoperative Educational Videos Reduce Maternal Anxiety Whose Children Received Congenital Heart Disease Surgery
|
N/A | |
| Completed |
NCT00835016 -
Early Psychosocial Stimulation Program for Children of Depressed Mothers
|
N/A | |
| Completed |
NCT03430622 -
Learning Through Play (LTP) Plus Interpersonal Psychotherapy (IPT)
|
N/A | |
| Active, not recruiting |
NCT02911441 -
Evaluating CBT Delivered by Community Health Workers on Maternal Mental Health and Infant Cognitive Development in Insecure Environments
|
N/A | |
| Completed |
NCT02047357 -
Participatory Intervention to Reduce Maternal Depression and Under Five Child Morbidity
|
N/A | |
| Completed |
NCT01182363 -
Reducing Risk After an Adverse Pregnancy Outcome
|
N/A | |
| Completed |
NCT01326182 -
Intervention for Depressed Latina Mothers of Children With Asthma
|
Phase 2 |