- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04296734
Prenatal Depression Prevention Effects on Parenting and Young Child Self-Regulation and Functioning (EPIC)
Effects of a Prenatal Depression Preventive Intervention on Parenting and Young Children's Self-Regulation and Functioning (EPIC)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: S. Darius Tandon, PhD
- Phone Number: 312-503-3398
- Email: dtandon@northwestern.edu
Study Contact Backup
- Name: Alicia Diebold, MSW
- Phone Number: 586-419-3610
- Email: alicia.diebold@northwestern.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University Feinberg School of Medicine
-
Contact:
- Alicia Diebold, MSW
- Phone Number: 312-503-4817
- Email: alicia.diebold@northwestern.edu
-
Principal Investigator:
- S. Darius Tandon, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion/Exclusion Criteria:
Women enrolled in parent-study:
- ≥ 16 years of age
- ≤33 weeks' gestation upon referral
- English or Spanish speaking
New Cohort:
- English or Spanish speaking
- ≥ 18 years of age
- Have a child 18-30 months old at the time of recruitment
Partners of female study participants:
- ≥ 18 years of age
- English or Spanish speaking
- Have contact with the child of one of the existing/new female participants
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal depressive symptoms
Time Frame: Child age 30-54 months
|
Measured by the 16-item Quick Inventory of Depressive Symptomatology (QIDS).
Total score ranges from 0-27.
Scores between 0-5 (no depression); 6-10 (Mild Depression); 11-15 (Moderate); 16-20 ( Severe); 21+ (Very Severe) .
|
Child age 30-54 months
|
Parenting outcomes ) of parenting self-efficacy (SE) and Parenting Hostile Reactive Behavior (HRB)
Time Frame: Child age 30-54 months
|
Measured by the Parental Cognitions and Conduct Toward the Infant Scale (PACOTIS).
Scores range from 0-10.
Higher mean scores indicate greater self-efficacy, hostile-reactive parenting, perceived parental impact, and parental overprotection
|
Child age 30-54 months
|
Child self-regulation outcomes
Time Frame: Child age 30-54 months
|
Measured by the Early Childhood Behavior Questionnaire-Very Short Form (ECBQ-VS). Items indicated with an R on the items-by-scale list below are reverse-scored. Sum the scores for items receiving a numerical response. Negative Affect (12 items): 16,17,19,32,2,26,10,22,23,1,33,34R Surgency (12 items): 4,13,18,20,24,6,11,9,25,3,30,36 Effortful Control (12 items): 21,27,31,8,15,35,7,14R,12R,29,5,28 Effortful Control measured by the Multidimensional Assessment Profile of Disruptive Behavior Short Form (MAP-DB) Temper Loss Subscale. A sum of the 49 short-form items to indicate total Disruptive Behavior (DB); A sum of the 22 TL items (15+7) to indicate Temper Loss. The scale goes from 0 (never) to 5 (many times each day). Higher scores indicate higher levels of problems. |
Child age 30-54 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal mental health and cognitive-behavioral skills
Time Frame: Child age 30-54 months
|
|
Child age 30-54 months
|
Parenting outcomes of parental positive affect, sensitive responsiveness, and verbalizations
Time Frame: Child age 36-48 months
|
Measured by the Brief Early Relational Assessment (BERA).
Coding factors are Child, Parent, and Dyadic.
Each item on a factor is scored from 1-5 with 1-2=no concern, 3=some concern, 4-5=areas of strength.
All items on a factor are added and divided by the number of items on the factor to get a mean score.
There is no overall score.
|
Child age 36-48 months
|
Child self-regulation outcomes
Time Frame: Child age 36-48 months
|
Measured by: a. Devereaux Early Childhood Assessment (DECA) Initiative, Attachment/relationships, Self-regulations subscales (Time frame: Child age 30-54 months). Four subscales: initiative, self-regulation, attachment/relationships, behavioral concerns. Each item rated 0-4. For each subscale, sum responses to get a scale raw score. Use the scoring guide to get the child's Protective Factor Profile based on the Self-regulation, attachment/relationships, and behavioral concerns raw scores. b. Disruptive Diagnostic Observation Schedule (DB-DOS) Problems in Behavioral Regulation. 3 domains: Problems in anger modulation, problems in behavioral regulation, competence. Ratings are made on a 4-point scale ranging from 0 (none) to 3 (high). Scores are derived as sums of each domain. |
Child age 36-48 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: S. Darius Tandon, PhD, Northwestern University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HD097215
- GRANT12740559 (Other Grant/Funding Number: NICHD)
- 1R01HD097215-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postpartum Depression
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Women's Health Research Institute...CompletedPostpartum Depression | Perinatal Disorder | Postpartum Disorder | Perinatal Depression | Postpartum Anxiety | Postnatal DepressionCanada
-
University of CoimbraEnrolling by invitationPostPartum DepressionPortugal
-
University of MinnesotaNational Institute of Mental Health (NIMH)Completed
-
Sage TherapeuticsCompletedSevere Postpartum DepressionUnited States
-
Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalCompletedPostpartum Depression | Postpartum Anxiety | Postpartum Blues | Postpartum Mood DisorderCanada
-
Gazi UniversityCompletedPostpartum Depression | Postpartum AdaptationTurkey
-
British Columbia Children's HospitalActive, not recruiting
-
University of RochesterMae Stone Goode FoundationCompletedPostpartum Depression | Postpartum AnxietyUnited States
-
Hacettepe UniversityCompletedQuality of Life | Postpartum Depression | Nursing Caries | Nurse's Role | Postpartum Disorder | Postpartum AnxietyTurkey
Clinical Trials on Mothers and Babies
-
Northwestern UniversityNational Institute on Minority Health and Health Disparities (NIMHD)CompletedPostpartum Depression | Perinatal DepressionUnited States
-
Northwestern UniversityCompletedPerinatal Depression | PostPartum DepressionUnited States
-
Northwestern UniversityAnn & Robert H Lurie Children's Hospital of ChicagoCompletedPregnancy | Prenatal StressUnited States
-
Sidra Medical and Research CenterNorthwestern UniversityUnknownDiabetes | Postpartum Depression | Anxiety
-
Northwestern UniversityNational Institute of Mental Health (NIMH); Palo Alto UniversityActive, not recruiting
-
Duke UniversityCatholic Relief ServicesCompleted
-
Northwestern UniversityJohns Hopkins University; Palo Alto UniversityRecruiting
-
University of Missouri-ColumbiaFahs Beck Fund for Research and ExperimentationCompletedDepression | Anxiety Disorders GeneralizedUnited States
-
University of California, San FranciscoNational Institute of Mental Health (NIMH)CompletedDepression | Postpartum DepressionUnited States
-
Johns Hopkins UniversityAbell FoundationCompleted