Postpartum DepressionEPICNCT04296734
Prenatal Depression Prevention Effects on Parenting and Young Child Self-Regulation and Functioning
An observational study of Postpartum Depression and Child Development, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Postpartum Depression, Child Development, Parenting
- What is being tested?
- Mothers and Babies
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 960 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2019to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- Child, Adult, Older adult
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
Who may be able to join
- Women enrolled in parent-study:
- ≥ 16 years of age
- ≤33 weeks' gestation upon referral
- English or Spanish speaking
- New Cohort:
- English or Spanish speaking
Show all 12Show fewer
- ≥ 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Effects of a Prenatal Depression Preventive Intervention on Parenting and Young Children's Self-Regulation and Functioning (EPIC)
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.
Read the 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.
- Being tested
- Mothers and Babies
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mothers and BabiesBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: 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
Measured: 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.
Measured: Child age 30-54 months
Secondary outcomes (3)
Maternal mental health and cognitive-behavioral skills
- Behavioral activation measured by the Behavioral Activation for Depression Scale (BADS). The BADS consists of 25 items, each rated on a 7-point scale, with higher scores indicating greater behavioral activation.
- Decentering measured by Experiences Questionnaire (EQ). Total Score is the sum of all 20 items. The higher the score the higher the decentering/rumination.
- Social support measured by Medical Outcomes Study Social Support Survey (MOS-SS). 19 items, with greater scores indicating more perceived social support.
- Perceived stress measured by the 4-item Perceived Stress Scale (PSS-4). Higher scores are correlated to more stress.
- Relationship with partner measured by the Revised Dyadic Adjustment Scale (RDAS). The total score is the sum of the responses to the 7 items. Higher scores indicate greater relationship satisfaction.
Measured: Child age 30-54 months
Parenting outcomes of parental positive affect, sensitive responsiveness, and verbalizations
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.
Measured: Child age 36-48 months
Child self-regulation outcomes
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.
- 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.
Measured: Child age 36-48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start14 Nov 2019
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 960 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Darius Tandon, Northwestern University
- Investigators
- S. Darius Tandon, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296734
- Sponsor's protocol ID
- HD097215
- Other IDs
- GRANT12740559, 1R01HD097215-01A1
- Acronym
- EPIC
- Status last verified
- May 2024
- First submitted
- 13 Nov 2019
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34246233
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Prenatal Depression Preventive Intervention on Parenting and Young Children's Self-Regulation and Functioning (EPIC)
- ClinicalTrials.gov ID
- NCT04296734
- Acronym / sponsor ID
- EPIC / HD097215
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 960 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (12 listed)
- ≥ 16 years of age
- ≤33 weeks' gestation upon referral
- English or Spanish speaking
- English or Spanish speaking
- ≥ 18 years of age
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mothers and BabiesMothers \& 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. | Behavioural | – |
Primary outcome
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) .
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 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.
3 secondary outcomes
Maternal mental health and cognitive-behavioral skills
Time frame: Child age 30-54 months
Parenting outcomes of parental positive affect, sensitive responsiveness, and verbalizations
Time frame: Child age 36-48 months
Child self-regulation outcomes
Time frame: Child age 36-48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Derived from this study: PubMed 34246233Diebold 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S. Darius Tandon, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Depression and Child Development, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal depressive symptoms (time frame: Child age 30-54 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04296734, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.