Depression Clinical Trial
Official title:
Interconception Care at the University of Mississippi Medical Center: An Innovative and Unique Collaborative Continuous Quality Improvement Project Between the Departments of Pediatrics and Family Medicine
Verified date | April 2020 |
Source | University of Mississippi Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This model will utilize tools from the IMPLICIT (Interventions to Minimize Preterm and Low Birth Weight Infant through Continuous Quality Improvement Techniques) Network (collaboration of academic family medicine providers). The project involves assessing maternal risk behaviors that significantly affect subsequent birth outcomes: specifically smoking cessation, maternal depression, family planning and preconception folic acid supplementation during well child (WCC) visits. There is evidence that screening mothers for depression can be done at WCC. Data from IMPLCIT network has demonstrated increased screening and referral rates as well as decreased rates of prematurity. This is the first collaborative effort between Pediatrics and Family Medicine.
Status | Enrolling by invitation |
Enrollment | 1625 |
Est. completion date | January 2026 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 67 Years |
Eligibility |
Inclusion Criteria: 1. Pediatric Primary Care Providers and Family Medicine Providers at UMMC 2. Mothers of young infants/toddlers who present with their children for well child visits to UMC primary clinics - Exclusion Criteria: 1. Specialists at UMMC 2. Fathers, grandparents, legal guardians - this screening only applies to mothers of young infants and toddlers - |
Country | Name | City | State |
---|---|---|---|
United States | Univeristy of Mississippi Medical Center | Jackson | Mississippi |
Lead Sponsor | Collaborator |
---|---|
University of Mississippi Medical Center | IMPLICIT Network, March of Dimes |
United States,
2015 Premature Birth Report Cards. march of Dimes. http//:www.marchofdimes.org/mission/prematurity-reportcard.aspx. Accessed 2/18/2016
Goedhart G, Snijders AC, Hesselink AE, van Poppel MN, Bonsel GJ, Vrijkotte TG. Maternal depressive symptoms in relation to perinatal mortality and morbidity: results from a large multiethnic cohort study. Psychosom Med. 2010 Oct;72(8):769-76. doi: 10.1097/PSY.0b013e3181ee4a62. Epub 2010 Jul 28. — View Citation
Johnson K, Posner SF, Biermann J, Cordero JF, Atrash HK, Parker CS, Boulet S, Curtis MG; CDC/ATSDR Preconception Care Work Group; Select Panel on Preconception Care. Recommendations to improve preconception health and health care--United States. A report of the CDC/ATSDR Preconception Care Work Group and the Select Panel on Preconception Care. MMWR Recomm Rep. 2006 Apr 21;55(RR-6):1-23. — View Citation
MacDorman MF, Mathews TJ. Behind international rankings of infant mortality: how the United States compares with Europe. NCHS Data Brief. 2009 Nov;(23):1-8. — View Citation
Maternal, Infant and Child Health. Healthy People 2020. https://www.healthypeople.gov/2020/topics-objectives/topic/maternal-infant-and-child-health.Accessed 2/18/2016
Murin S, Rafii R, Bilello K. Smoking and smoking cessation in pregnancy. Clin Chest Med. 2011 Mar;32(1):75-91. doi: 10.1016/j.ccm.2010.11.004. Review. — View Citation
Ratcliffe S, Gambler A, Gross M, Horst M, Raff T. Preventing Prematurity: One Woman at a Time. The Journal of Lancaster General Hospital. Fall 2012,(7):3;69-74
Santos IS, Matijasevich A, Silveira MF, Sclowitz IK, Barros AJ, Victora CG, Barros FC. Associated factors and consequences of late preterm births: results from the 2004 Pelotas birth cohort. Paediatr Perinat Epidemiol. 2008 Jul;22(4):350-9. doi: 10.1111/j.1365-3016.2008.00934.x. — View Citation
Sheeder J, Kabir K, Stafford B. Screening for postpartum depression at well-child visits: is once enough during the first 6 months of life? Pediatrics. 2009 Jun;123(6):e982-8. doi: 10.1542/peds.2008-1160. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Can pediatric primary care provider screen mother for maternal health behaviors during routine well child visits using brief questionnaires? | Pediatric primary care providers (and family medicine providers who care for young infants) will screen mothers for maternal behaviors (smoking status, depression, prenatal multivitamin use, family planning) during routine well child visits of infants aged 0-2 years of age. Mothers will be screened for depression using a validated screening tool (Patient Health Questionnaire or PHQ: the 2 item PHQ-2 will be an initial screen; mothers who have a positive PHQ-2 will be offered the 9-item questionnaire ie the PHQ-9); screening for family planning needs, prenatal multivitamin use and smoking status will be in the form of "yes/no" answers. | 2 years | |
Secondary | Can pediatric primary care providers make appropriate recommendations for mothers with at risk behaviors using brief questionnaires? | Pediatric primary care providers (and family medicine providers who care for young infants) will offer resources for mothers in need of treatment for the following conditions: smoking cessation, depression, multivitamin use, contraception. The Patient Health Questionnaire (PHQ) will be used to screen for depression. The PHQ-2 will be used as an initial screen for depression, mothers who have a positive PHQ-2 will be offered the PHQ-9. Mothers will be screened for suicidal ideation and referred for immediate resources if needed. Mothers who screen positive for depression and not suicidal will be referred to mental health specialists. Mothers will be queried (using "yes/no" responses) with respect to smoking status (mothers will be referred to a smoking cessation program if needed); contraceptive resources will be offered if needed; prenatal vitamins will be recommended if needed. Recommendations will be tracked within the infant's electronic health record. | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A |