Clinical trial NCT04296734: Prenatal Depression Prevention Effects on Parenting and Young Child Self-Regulation and Functioning
Official title: Effects of a Prenatal Depression Preventive Intervention on Parenting and Young Children's Self-Regulation and Functioning (EPIC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Depression
Child Development
Parenting
Child Self-Regulation
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Ann & Robert H Lurie Children's Hospital of Chicago
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-03-05
Enrollment: 960
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Detailed description: The proposed R01 project Effects of a Prenatal Depression Preventive Intervention on Parenting and Young Children's Self-Regulation and Functioning (EPIC) examines whether a prenatal depression prevention intervention-Mothers and Babies (MB)-improves parenting practices and child self-regulation through 54 months of age. The investigators build on an existing cluster randomized controlled trial that enrolled 874 diverse, low-income women from 36 home visiting (HV) programs. The investigators anticipate 598 of these women will be eligible for EPIC (489 intervention, 109 control) and the research team will enroll an additional 260 control participants as part of this R01, for a total sample of 858. The research team will also enroll 429 fathers. Perinatal depression is consistently linked to poor parenting practices and poor child self-regulation. This project builds on previous work that has demonstrated MB's effects on improving maternal mental health outcomes and will examine the intervention's longer-term impact on parenting and child self-regulation from 30-54 months of age. Intervention participants will have received the six-week MB intervention delivered in a group format in addition to usual HV services while control participants will have only received HV services. Data collection for the R01 includes maternal self-report with all 858 participants every six months, beginning at 30 months postpartum and continuing until 54 months postpartum. An intensive sub-study of parenting and child development will occur at 36, 42, and 48 months for a subset of 460 participants (230 intervention, 230 control). Paternal self-report surveys will occur at 30, 42, and 54 months. There are three specific aims. First, the investigators test the hypothesis that MB improves parenting and child self-regulatory skill acquisition through 54 months of age. The investigators will use intent-to-treat as well as propensity score adjusted analysis. Second, the investigators test hypotheses about the maternal mechanisms by which MB influences parenting and child self-regulation. The investigators hypothesize that MB intervention effects will be mediated by core skills targeted by MB-in particular, increased awareness of thoughts and feelings and increases in mood regulation-as these cognitive-behavioral skills are deficient in mothers with depressive symptoms and compromise mothers' ability to engage in parenting practices that promote young children's self-regulation. Third, the investigators will examine fathers' and other key sociodemographic variables' role in moderating the impact of MB on mother's parenting and the child's self-regulation. The public health significance and innovation of this project is substantial. Addressing maternal mental health has been identified as a highly impactful enhancement to HV programs. If, as expected, the investigators are able to generate a robust science base that precisely identifies mechanisms and outcomes impacted by the intervention in young children among our racially and ethnically diverse sample, HV programs currently using MB are likely to enhance their programmatic outcomes. Moreover, given the large number of HV programs that could adopt MB nationally, findings from this study can provide powerful data suggesting that MB become integrated into their core set of services.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal depressive symptoms
timeFrame: Child age 30-54 months
measure: Parenting outcomes ) of parenting self-efficacy (SE) and Parenting Hostile Reactive Behavior (HRB)
timeFrame: Child age 30-54 months
measure: Child self-regulation outcomes
timeFrame: Child age 30-54 months
Secondary outcomes:
measure: Maternal mental health and cognitive-behavioral skills
timeFrame: Child age 30-54 months
measure: Parenting outcomes of parental positive affect, sensitive responsiveness, and verbalizations
timeFrame: Child age 36-48 months
measure: Child self-regulation outcomes
timeFrame: Child age 36-48 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: S. Darius Tandon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.