Infant Development, Maternal Depression and Parent Practices, Postpartum
Conditions
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
Brief 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
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.
Interventions
BEHAVIORALMom & 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
BEHAVIORALDepression & 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)
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Oregon Research Institute
The University of Texas Health Science Center, Houston
Georgia State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Assessment coders and participants are naive to treatment condition
Intervention model description
Two arm, randomized controlled intent to treat trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PHQ9 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
Countries
United States
Participant flow
Pre-assignment details
Participant flow shows 368 total participants enrolled, which matches the Protocol section documenting 368 total participants enrolled
Participants by arm
| Arm | Count |
|---|---|
| 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
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 | 184 |
| 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)
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) | 184 |
| Total | 368 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 62 | 52 |
| Overall Study | Passive Disengagement | 8 | 4 |
| Overall Study | Withdrawal by Subject | 16 | 10 |
Baseline characteristics
| Characteristic | Mom & Baby Net | Depression & Developmental Awareness System | Total |
|---|---|---|---|
| Age, Categorical Infants <=18 years | 91 Participants | 92 Participants | 183 Participants |
| Age, Categorical Infants >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Infants Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Mothers <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Mothers >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Mothers Between 18 and 65 years | 91 Participants | 92 Participants | 183 Participants |
| Age, Continuous Infants | 0.51 years STANDARD_DEVIATION 0.25 | 0.50 years STANDARD_DEVIATION 0.23 | 0.50 years STANDARD_DEVIATION 0.24 |
| Age, Continuous Mothers | 27.63 years STANDARD_DEVIATION 5.9 | 28.58 years STANDARD_DEVIATION 5.71 | 28.11 years STANDARD_DEVIATION 5.81 |
| Ethnicity (NIH/OMB) Infants Hispanic or Latino | 3 Participants | 7 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Infants Not Hispanic or Latino | 88 Participants | 85 Participants | 173 Participants |
| Ethnicity (NIH/OMB) Infants Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Mothers Hispanic or Latino | 1 Participants | 4 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Mothers Not Hispanic or Latino | 90 Participants | 88 Participants | 178 Participants |
| Ethnicity (NIH/OMB) Mothers Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Infants American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Infants Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Infants Black or African American | 75 Participants | 84 Participants | 159 Participants |
| Race (NIH/OMB) Infants More than one race | 6 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) Infants Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Infants Unknown or Not Reported | 6 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) Infants White | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Mothers American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Mothers Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Mothers Black or African American | 78 Participants | 84 Participants | 162 Participants |
| Race (NIH/OMB) Mothers More than one race | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Mothers Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Mothers Unknown or Not Reported | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Mothers White | 4 Participants | 1 Participants | 5 Participants |
| Region of Enrollment United States | 92 participants | 92 participants | 184 participants |
| Sex: Female, Male Infants Female | 44 Participants | 48 Participants | 92 Participants |
| Sex: Female, Male Infants Male | 47 Participants | 44 Participants | 91 Participants |
| Sex: Female, Male Mothers Female | 91 Participants | 92 Participants | 183 Participants |
| Sex: Female, Male Mothers Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 92 | 0 / 92 | 0 / 92 | 0 / 92 |
| other Total, other adverse events | 0 / 92 | 0 / 92 | 0 / 92 | 0 / 92 |
| serious Total, serious adverse events | 0 / 92 | 0 / 92 | 0 / 92 | 0 / 92 |
Outcome results
Primary
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)
Time frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Population: Number analyzed differs due to missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mom & Baby Net | Indicator of Parent Child Interaction (IPCI) - Child Engagement | Pre-intervention | 31.14 percentage of occurrence | Standard Deviation 15.89 |
| Mom & Baby Net | Indicator of Parent Child Interaction (IPCI) - Child Engagement | Post-intervention | 42.44 percentage of occurrence | Standard Deviation 15.09 |
| Depression & Developmental Awareness System | Indicator of Parent Child Interaction (IPCI) - Child Engagement | Pre-intervention | 32.70 percentage of occurrence | Standard Deviation 14.4 |
| Depression & Developmental Awareness System | Indicator of Parent Child Interaction (IPCI) - Child Engagement | Post-intervention | 40.56 percentage of occurrence | Standard Deviation 16.78 |
p-value: 0.349GLM Repeated Measures
Primary
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);
Time frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Population: Number analyzed differs due to missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mom & Baby Net | Indicator of Parent Child Interaction (IPCI) - Child Positive Social | Pre-intervention | 16.50 percentage of occurrence | Standard Deviation 14.83 |
| Mom & Baby Net | Indicator of Parent Child Interaction (IPCI) - Child Positive Social | Post-intervention | 27.96 percentage of occurrence | Standard Deviation 14.83 |
| Depression & Developmental Awareness System | Indicator of Parent Child Interaction (IPCI) - Child Positive Social | Post-intervention | 25.81 percentage of occurrence | Standard Deviation 18.16 |
| Depression & Developmental Awareness System | Indicator of Parent Child Interaction (IPCI) - Child Positive Social | Pre-intervention | 14.82 percentage of occurrence | Standard Deviation 14.29 |
p-value: 0.898GLM Repeated Measures
Primary
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);
Time frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Population: Number analyzed differs due to missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mom & Baby Net | Indicator of Parent Child Interaction (IPCI) - Mother Maintain/Extend | Pre-intervention | 1.92 percentage of occurrence | Standard Deviation 6 |
| Mom & Baby Net | Indicator of Parent Child Interaction (IPCI) - Mother Maintain/Extend | Post-intervention | 5.83 percentage of occurrence | Standard Deviation 13.02 |
| Depression & Developmental Awareness System | Indicator of Parent Child Interaction (IPCI) - Mother Maintain/Extend | Pre-intervention | 3.45 percentage of occurrence | Standard Deviation 7.54 |
| Depression & Developmental Awareness System | Indicator of Parent Child Interaction (IPCI) - Mother Maintain/Extend | Post-intervention | 3.66 percentage of occurrence | Standard Deviation 7.22 |
p-value: 0.08GLM Repeated Measures
Primary
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)
Time frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Population: Number analyzed differs due to missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mom & Baby Net | Indicator of Parent Child Interaction (IPCI) - Mother Overall Positive | Pre-intervention | 29.79 percentage of occurrence | Standard Deviation 15.46 |
| Mom & Baby Net | Indicator of Parent Child Interaction (IPCI) - Mother Overall Positive | Post-intervention | 39.47 percentage of occurrence | Standard Deviation 18.54 |
| Depression & Developmental Awareness System | Indicator of Parent Child Interaction (IPCI) - Mother Overall Positive | Pre-intervention | 30.39 percentage of occurrence | Standard Deviation 18.63 |
| Depression & Developmental Awareness System | Indicator of Parent Child Interaction (IPCI) - Mother Overall Positive | Post-intervention | 33.54 percentage of occurrence | Standard Deviation 15.45 |
p-value: 0.09GLM Repeated Measures
Primary
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
Time frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Population: Discrepancy between Participant Flow and analyzed number is due to missing data for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mom & Baby Net | Knowledge of Infant Social-Emotional Development and Promotion | Pre-intervention | 8.62 score on a scale | Standard Deviation 0.45 |
| Mom & Baby Net | Knowledge of Infant Social-Emotional Development and Promotion | Post-intervention | 14.66 score on a scale | Standard Deviation 0.56 |
| Depression & Developmental Awareness System | Knowledge of Infant Social-Emotional Development and Promotion | Pre-intervention | 8.01 score on a scale | Standard Deviation 0.41 |
| Depression & Developmental Awareness System | Knowledge of Infant Social-Emotional Development and Promotion | Post-intervention | 8.54 score on a scale | Standard Deviation 0.51 |
p-value: <0.001GLM Repeated Measures
Primary
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)
Time frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Population: Numbers analyzed differ due to missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mom & Baby Net | Landry Parent Child Interaction Rating Scales - Child Positive/Engagement Behavior | Pre-Intervention | 5.21 score on a scale | Standard Deviation 1.94 |
| Mom & Baby Net | Landry Parent Child Interaction Rating Scales - Child Positive/Engagement Behavior | Post-Intervention | 6.35 score on a scale | Standard Deviation 2.2 |
| Depression & Developmental Awareness System | Landry Parent Child Interaction Rating Scales - Child Positive/Engagement Behavior | Pre-Intervention | 4.97 score on a scale | Standard Deviation 1.99 |
| Depression & Developmental Awareness System | Landry Parent Child Interaction Rating Scales - Child Positive/Engagement Behavior | Post-Intervention | 5.92 score on a scale | Standard Deviation 1.95 |
p-value: 0.702GLM Repeated Measures
Primary
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)
Time frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Population: Numbers analyzed differ due to missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mom & Baby Net | Landry Parent Child Interaction Rating Scales - Mother Negative Behavior | Pre-Intervention | 0.27 score on a scale | Standard Deviation 0.06 |
| Mom & Baby Net | Landry Parent Child Interaction Rating Scales - Mother Negative Behavior | Post-Intervention | 0.21 score on a scale | Standard Deviation 0.06 |
| Depression & Developmental Awareness System | Landry Parent Child Interaction Rating Scales - Mother Negative Behavior | Post-Intervention | 0.38 score on a scale | Standard Deviation 0.05 |
| Depression & Developmental Awareness System | Landry Parent Child Interaction Rating Scales - Mother Negative Behavior | Pre-Intervention | 0.25 score on a scale | Standard Deviation 0.05 |
p-value: 0.059GLM Repeated Measures
Primary
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);
Time frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Population: Numbers analyzed differ due to missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mom & Baby Net | Landry Parent Child Interaction Rating Scales - Mother Positive Behavior | Pre-Intervention | 12.43 score on a scale | Standard Deviation 3.72 |
| Mom & Baby Net | Landry Parent Child Interaction Rating Scales - Mother Positive Behavior | Post-Intervention | 15.54 score on a scale | Standard Deviation 3.1 |
| Depression & Developmental Awareness System | Landry Parent Child Interaction Rating Scales - Mother Positive Behavior | Pre-Intervention | 13.16 score on a scale | Standard Deviation 4.02 |
| Depression & Developmental Awareness System | Landry Parent Child Interaction Rating Scales - Mother Positive Behavior | Post-Intervention | 13.04 score on a scale | Standard Deviation 3.94 |
p-value: <0.001GLM Repeated Measures
Primary
PHQ9
Depression symptoms; Patient Health Questionnaire-9; values = 0-27; higher scores = worse outcome
Time frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Population: Discrepancy between Participant Flow and analyzed number is due to missing data for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mom & Baby Net | PHQ9 | Pre-intervention | 11.94 score on a scale | Standard Deviation 6.35 |
| Mom & Baby Net | PHQ9 | Post-intervention | 5.61 score on a scale | Standard Deviation 5.6 |
| Depression & Developmental Awareness System | PHQ9 | Pre-intervention | 10.31 score on a scale | Standard Deviation 6.74 |
| Depression & Developmental Awareness System | PHQ9 | Post-intervention | 5.33 score on a scale | Standard Deviation 5.85 |
p-value: 0.503GLM Repeated Measures