Prenatal Depression Prevention Effects on Parenting and Young Child Self-Regulation and Functioning

NCT04296734 | Completed

• 3 other identifiers: HD097215GRANT127405591R01HD097215-01A1
• Study Type: observational
• Target: 960
• Locations: 1 country
• Sites: 1

Brief Summary

Poor parenting practices and compromised child self-regulation when a child is 2 ½ - 4 ½ years old are foundational in promoting their later healthy development and adaptive functioning. This project will test whether targeting depressive symptoms with a prenatal preventive intervention prevents disruptions in well-regulated parenting and child self-regulation known to affect families with depressed mothers. This project may have great benefit to society, as preventive interventions delivered prenatally have the potential to influence long-term trajectories of parenting practices and child development which, in turn, can chart a course for future child health and well-being.

Conditions

Postpartum Depression; Child Development; Parenting; Child Self-Regulation

Outcome Measures

Primary Outcomes (3)

• Maternal depressive symptoms

  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)

  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

  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 Outcomes (3)

• Maternal mental health and cognitive-behavioral skills

  Child age 30-54 months

• Parenting outcomes of parental positive affect, sensitive responsiveness, and verbalizations

  Child age 36-48 months

• Child self-regulation outcomes

  Child age 36-48 months

Interventions

Mothers and Babies BEHAVIORAL

Mothers \& Babies (MB) is a program that promotes healthy mood management by teaching pregnant women and new moms how to effectively respond to stress in their lives through increasing the frequency of thoughts and behaviors that lead to positive mood states. Designed as a perinatal depression prevention, the Mothers \& Babies targets three specific risk factors: limited social support, lack of pleasant activities, and harmful thought patterns.

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study builds on a currently ongoing parent study that enrolled pregnant women from home visiting (HV) programs across seven states to examine the effects of a cognitive-behavioral therapy (CBT) intervention-Mothers and Babies (MB)-on maternal mental health through six months postpartum. This follow-up study will retain the same cohort of women enrolled in that study and recruit additional women to serve as control participants. Children will be ages 30 months to 54 months in this study. The research team will also recruit a cohort of fathers in this follow-up study

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Diebold A, Johnson JK, Brennan M, Ciolino JD, Petitclerc A, Wakschlag LS, Garfield CF, Yeh C, Lovejoy A, Zakieh D, Tandon SD. Testing the effects of a prenatal depression preventive intervention on parenting and young children's self-regulation and functioning (EPIC): protocol for a longitudinal observational study. BMC Public Health. 2021 Jul 10;21(1):1368. doi: 10.1186/s12889-021-11385-5.

  PMID: 34246233 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• S. Darius Tandon, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Medical Social Sciences Co-Director, Center for Community Health

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: March 5, 2020
• Study Start: November 14, 2019
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)