Maternal Depression and Parent Practices, PostpartumMBNNCT03464630
Reducing Maternal Depression and Promoting Infant Social-Emotional Health & Development
A study testing Mom & Baby Net and Depression & Developmental Awareness System in people with Maternal Depression and Parent Practices, Postpartum and Infant Development, run by Georgia State University at 1 site in United States.
Trial summary
A mobile remote coaching program study to improve maternal mood and increase parenting practices that lead to better infant social-emotional and communication outcomes Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Depression and Parent Practices, Postpartum, Infant Development
- What is being tested?
- Mom & Baby Net and Depression & Developmental Awareness System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2018to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
A mobile remote coaching program study to improve maternal mood and increase parenting practices that lead to better infant social-emotional and communication outcomes
Read the 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.
- Being tested
- Mom & Baby Net, Depression & Developmental Awareness System
- Keywords
- Treatment Maternal depression postpartum, Optimizing Maternal parenting practices, Optimizing Infant development, Optimizing Infant behavior, Direct observation of mother-Infant interaction, M health intervention, Remote coaching, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mom & Baby NetBehavioural
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
Depression & Developmental Awareness SystemBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Mom & Baby Net | Experimental | 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 Receives: Behavioral: Mom & Baby Net |
| Depression & Developmental Awareness System | Active comparator | 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) Receives: Behavioral: Depression & Developmental Awareness System |
What is being measured
The primary outcome is the main question the study is designed to answer.
PHQ9
Depression symptoms; Patient Health Questionnaire-9; values = 0-27; higher scores = worse outcome
Measured: 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
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);
Measured: 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
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)
Measured: 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
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)
Measured: 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
Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes:
Mother Maintain/Extend (values = 0-100%; higher = better outcomes);
Measured: 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
Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes:
Mother Overall Positive (values = 0-100%; higher = better outcomes)
Measured: 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
Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes:
Child Positive Social (values = 0-100%; higher = better outcomes);
Measured: 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
Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes:
Child Engagement (values = 0-100%; higher = better outcomes)
Measured: 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
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
Measured: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start15 Feb 2018
- Primary completion1 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Maternal Depression and Parent Practices, PostpartumStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm, randomized controlled intent to treat trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Oregon Research Institute, The University of Texas Health Science Center, Houston
- Responsible party
- Principal investigator, Kathleen Baggett, Georgia State University
- Investigators
- Kathleen Baggett, PhD, Principal investigator, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464630
- Sponsor's protocol ID
- 1R01HD086894
- Other IDs
- R01HD086894-01A1
- Acronym
- MBN
- Status last verified
- May 2024
- First submitted
- 28 Feb 2018
- Last updated
- 20 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baggett KM, Davis B, Mosley EA, Miller K, Leve C, Feil EG. Depressed and Socioeconomically Disadvantaged Mothers' Progression Into a Randomized Controlled Mobile Mental Health and Parenting Intervention: A Descriptive Examination Prior to and During COVID-19. Front Psychol. 2021 Aug 12;12:719149. doi: 10.3389/fpsyg.2021.719149. eCollection 2021.
PubMed 34456828Baggett KM, Davis B, Sheeber LB, Ammerman RT, Mosley EA, Miller K, Feil EG. Minding the Gatekeepers: Referral and Recruitment of Postpartum Mothers with Depression into a Randomized Controlled Trial of a Mobile Internet Parenting Intervention to Improve Mood and Optimize Infant Social Communication Outcomes. Int J Environ Res Public Health. 2020 Dec 2;17(23):8978. doi: 10.3390/ijerph17238978.
PubMed 33276610Baggett KM, Davis B, Sheeber L, Miller K, Leve C, Mosley EA, Landry SH, Feil EG. Optimizing Social-Emotional-Communication Development in Infants of Mothers With Depression: Protocol for a Randomized Controlled Trial of a Mobile Intervention Targeting Depression and Responsive Parenting. JMIR Res Protoc. 2021 Aug 18;10(8):e31072. doi: 10.2196/31072.
PubMed 34406122
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Maternal Depression and Promoting Infant Social-Emotional Health & Development
- ClinicalTrials.gov ID
- NCT03464630
- Acronym / sponsor ID
- MBN / 1R01HD086894
- Keywords
- Treatment Maternal depression postpartum, Optimizing Maternal parenting practices, Optimizing Infant development, Optimizing Infant behavior, Direct observation of mother-Infant interaction, M health intervention, Remote coaching, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Oregon Research Institute, The University of Texas Health Science Center, Houston
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 14 Mar 2018 (actual)
- Results
- Posted 20 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A mobile remote coaching program study to improve maternal mood and increase parenting practices that lead to better infant social-emotional and communication outcomes
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two arm, randomized controlled intent to treat trial
| Arm | Type | Receives |
|---|---|---|
| Mom & Baby Net | Experimental | Behavioral: Mom & Baby NetCBT 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 |
| Depression & Developmental Awareness System | Active comparator | Behavioral: Depression & Developmental Awareness SystemSupportive, person-centered mobile intervention targeting maternal awareness of maternal depression symptoms, infant developmental milestones, and provision of community resources and referral (active control condition) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Mom & Baby NetCBT 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 | Behavioural | Mom & Baby Net |
| Depression & Developmental Awareness SystemSupportive, person-centered mobile intervention targeting maternal awareness of maternal depression symptoms, infant developmental milestones, and provision of community resources and referral (active control condition) | Behavioural | Depression & Developmental Awareness System |
Primary outcome
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
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);
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)
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)
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);
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)
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);
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)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34456828Baggett KM, Davis B, Mosley EA, Miller K, Leve C, Feil EG. Depressed and Socioeconomically Disadvantaged Mothers' Progression Into a Randomized Controlled Mobile Mental Health and Parenting Intervention: A Descriptive Examination Prior to and During COVID-19. Front Psychol. 2021 Aug 12;12:719149. doi: 10.3389/fpsyg.2021.719149. eCollection 2021.
- Background: PubMed 33276610Baggett KM, Davis B, Sheeber LB, Ammerman RT, Mosley EA, Miller K, Feil EG. Minding the Gatekeepers: Referral and Recruitment of Postpartum Mothers with Depression into a Randomized Controlled Trial of a Mobile Internet Parenting Intervention to Improve Mood and Optimize Infant Social Communication Outcomes. Int J Environ Res Public Health. 2020 Dec 2;17(23):8978. doi: 10.3390/ijerph17238978.
- Background: PubMed 34406122Baggett KM, Davis B, Sheeber L, Miller K, Leve C, Mosley EA, Landry SH, Feil EG. Optimizing Social-Emotional-Communication Development in Infants of Mothers With Depression: Protocol for a Randomized Controlled Trial of a Mobile Intervention Targeting Depression and Responsive Parenting. JMIR Res Protoc. 2021 Aug 18;10(8):e31072. doi: 10.2196/31072.
- Individual participant dataSharing planned: No
Related trials for Maternal Depression and Parent Practices, Postpartum
Not yet recruiting
Pilot Feasibility Study With Doulas
Post Partum, Maternal Depression
Recruiting
Essential Coaching Postpartum: Evaluating a Parent-focused Postpartum Text Message Program in Nova Scotia
Parenting Self-efficacy, Postpartum Anxiety
Recruiting
NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE)
Postpartum Depression (PPD), Self-Efficacy
RecruitingObservational study
Parental Well-being After Childbirth in Switzerland
Mental Health, Physical Health
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.
Kathleen Baggett, PhD principal investigator
Georgia State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mom & Baby Net and Depression & Developmental Awareness System in people with Maternal Depression and Parent Practices, Postpartum and Infant Development, run by Georgia State 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 5 inclusion and 1 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 20 Jun 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?
Yes. Results are posted in the registry (first posted 20 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PHQ9 (time frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)). The study lists 9 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 NCT03464630, which also lists 3 linked publications.
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 20 Jun 2024.