Reducing Maternal Depression and Promoting Infant Social-Emotional Health & Development (MBN)

May 28, 2024 updated by: Kathleen Baggett, Georgia State University
A mobile remote coaching program study to improve maternal mood and increase parenting practices that lead to better infant social-emotional and communication outcomes

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To address the life course needs of depressed mothers and their infants, brief, accessible, and integrated interventions that target both maternal depression and specific nurturing parent behaviors demonstrated to improve infant social-emotional communication outcomes are needed. In prior programmatic research, two separate web-based, remote coaching interventions for: (a) parent nurturing behaviors that improve infant outcomes (Baby-Net R34; R01) [13], and (b) maternal depression (Mom-Net R34; R01) [14] were developed. Compared to controls, the Baby-Net program demonstrated medium to large effects on observed nurturing parent behavior and on infant social-emotional competencies in the context of play [13] and in the context of book activities [15]. Mom-Net demonstrated low attrition and high levels of feasibility, program use, and satisfaction [14]. Compared to controls, Mom-Net participants demonstrated significant reductions in depression and improved preschool parenting behavior [14]. A substantial advantage of the mobile, remote coaching approach is that it overcomes multiple logistical barriers that often prevent low-income mothers from participating in community/home visiting treatment programs [2]. Thus, this prior research on web-based maternal depression and specific nurturing parenting behavior in infancy, provides a strong empirical basis for the Mom & Baby Net program. Investigators will rigorously test the merged Mom & Baby Net intervention effects with a total sample of 368 participants (184 mothers with depression and 184 infants) via a 2-arm, intent-to-treat, randomized controlled trial.

The start date of this grant-funded randomized controlled trial was September 1, 2016. Data collection is currently underway and scheduled to conclude in March 2022. Following IRB-approved pilot work, the randomized controlled trial was IRB- approved on November 17, 2017. Immediately following IRB approval, recruitment was initiated. Between February 15, 2018 and March 11, 2021, we successfully consented a total sample of 368 participants (184 women and 184 infants) into the randomized controlled trial. The sample is predominantly Black and socioeconomically disadvantaged.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
368

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30302
        • Georgia State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Mother is 18 years of age
  • Mother speaks English
  • Mother lives in metro-Atlanta area
  • Mother has baby younger than 12 months of age
  • Mother has positive depression screen (PHQ2)

Exclusion Criteria:

Stressors that mother specifies at the time of screening that would interfere with study participation such as: maternal homelessness, mental or physical health condition (diagnosed with schizophrenia or treatment/medication for hallucinations/delusions), current inpatient treatment for mental health or substance abuse. Infant exclusion criteria include factors that could render research participation stressful, such as intensive treatment for a genetic or health condition or not in permanent legal guardian custody

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mom & Baby Net
CBT skills based mobile intervention targeting maternal depression and sensitive responsive parenting practices for optimizing infant social-communication promotion and provision of community resources and referral
Behavioral: Mom & Baby Net
CBT skills based mobile intervention targeting maternal depression and sensitive responsive parenting practices for optimizing infant social-communication promotion and provision of community resources and referral
Active Comparator: Depression & Developmental Awareness System
Supportive, person-centered mobile intervention targeting maternal awareness of maternal depression symptoms, infant developmental milestones, and provision of community resources and referral (active control condition)
Behavioral: Depression & Developmental Awareness System
Supportive, person-centered mobile intervention targeting maternal awareness of maternal depression symptoms, infant developmental milestones, and provision of community resources and referral (active control condition)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PHQ9
Time Frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Depression symptoms; Patient Health Questionnaire-9; values = 0-27; higher scores = worse outcome
Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Landry Parent Child Interaction Rating Scales - Mother Positive Behavior
Time Frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

Rating scale used for coding observed parent and child behavior during semi-structured free play. Reported outcomes include:

mother positive behavior (values = 4-20; higher scores = better outcomes);
Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Landry Parent Child Interaction Rating Scales - Mother Negative Behavior
Time Frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

Dichotomized rating scale used for coding observed parent and child behavior during semi-structured free play. Reported outcomes include:

mother negative behavior (values = 0-1; higher scores = worse outcomes)
Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Landry Parent Child Interaction Rating Scales - Child Positive/Engagement Behavior
Time Frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

Rating scale used for coding observed parent and child behavior during semi-structured free play. Reported outcomes include:

child positive/engagement behavior (values = 2-10; higher scores = better outcomes)
Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Indicator of Parent Child Interaction (IPCI) - Mother Maintain/Extend
Time Frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes:

Mother Maintain/Extend (values = 0-100%; higher = better outcomes);
Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Indicator of Parent Child Interaction (IPCI) - Mother Overall Positive
Time Frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes:

Mother Overall Positive (values = 0-100%; higher = better outcomes)
Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Indicator of Parent Child Interaction (IPCI) - Child Positive Social
Time Frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes:

Child Positive Social (values = 0-100%; higher = better outcomes);
Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Indicator of Parent Child Interaction (IPCI) - Child Engagement
Time Frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes:

Child Engagement (values = 0-100%; higher = better outcomes)
Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Knowledge of Infant Social-Emotional Development and Promotion
Time Frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Rating scale used to assess understanding of the concepts of infant social-emotional behavior and its promotion by caregivers, assessing both definitional and applied concept knowledge; values = 0-28 higher scores = better outcomes
Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Georgia State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The University of Texas Health Science Center, Houston
Oregon Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kathleen Baggett, PhD, Georgia State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R01HD086894 (U.S. NIH Grant/Contract)
  • R01HD086894-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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