Trial Outcomes & Findings for Reducing Maternal Depression and Promoting Infant Social-Emotional Health & Development (NCT NCT03464630)
NCT ID: NCT03464630
Last Updated: 2024-06-20
Results Overview
Depression symptoms; Patient Health Questionnaire-9; values = 0-27; higher scores = worse outcome
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
368 participants
Primary outcome timeframe
Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Results posted on
2024-06-20
Participant Flow
Participant flow shows 368 total participants enrolled, which matches the Protocol section documenting 368 total participants enrolled
Participant milestones
| Measure |
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
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
184
|
184
|
|
Overall Study
Initiated & Completed Orientation Session
|
172
|
182
|
|
Overall Study
Initiated & Completed S1 Intervention Content
|
170
|
172
|
|
Overall Study
Initiated Post-Assessment
|
142
|
158
|
|
Overall Study
COMPLETED
|
98
|
118
|
|
Overall Study
NOT COMPLETED
|
86
|
66
|
Reasons for withdrawal
| Measure |
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
|
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)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
62
|
52
|
|
Overall Study
Withdrawal by Subject
|
16
|
10
|
|
Overall Study
Passive Disengagement
|
8
|
4
|
Baseline Characteristics
Age for one participant dyad is unknown
Baseline characteristics by cohort
| Measure |
Mom & Baby Net
n=184 Participants
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
|
Depression & Developmental Awareness System
n=184 Participants
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)
|
Total
n=368 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Mothers · <=18 years
|
0 Participants
n=91 Participants • Age for one participant dyad is unknown
|
0 Participants
n=92 Participants • Age for one participant dyad is unknown
|
0 Participants
n=183 Participants • Age for one participant dyad is unknown
|
|
Age, Categorical
Mothers · Between 18 and 65 years
|
91 Participants
n=91 Participants • Age for one participant dyad is unknown
|
92 Participants
n=92 Participants • Age for one participant dyad is unknown
|
183 Participants
n=183 Participants • Age for one participant dyad is unknown
|
|
Age, Categorical
Mothers · >=65 years
|
0 Participants
n=91 Participants • Age for one participant dyad is unknown
|
0 Participants
n=92 Participants • Age for one participant dyad is unknown
|
0 Participants
n=183 Participants • Age for one participant dyad is unknown
|
|
Age, Categorical
Infants · <=18 years
|
91 Participants
n=91 Participants • Age for one participant dyad is unknown
|
92 Participants
n=92 Participants • Age for one participant dyad is unknown
|
183 Participants
n=183 Participants • Age for one participant dyad is unknown
|
|
Age, Categorical
Infants · Between 18 and 65 years
|
0 Participants
n=91 Participants • Age for one participant dyad is unknown
|
0 Participants
n=92 Participants • Age for one participant dyad is unknown
|
0 Participants
n=183 Participants • Age for one participant dyad is unknown
|
|
Age, Categorical
Infants · >=65 years
|
0 Participants
n=91 Participants • Age for one participant dyad is unknown
|
0 Participants
n=92 Participants • Age for one participant dyad is unknown
|
0 Participants
n=183 Participants • Age for one participant dyad is unknown
|
|
Age, Continuous
Mothers
|
27.63 years
STANDARD_DEVIATION 5.90 • n=91 Participants • Age for one participant dyad is unknown. Mother and infant age are reported separately - infant age is reported in years and not months since we are unable to indicate two units of measure.
|
28.58 years
STANDARD_DEVIATION 5.71 • n=92 Participants • Age for one participant dyad is unknown. Mother and infant age are reported separately - infant age is reported in years and not months since we are unable to indicate two units of measure.
|
28.11 years
STANDARD_DEVIATION 5.81 • n=183 Participants • Age for one participant dyad is unknown. Mother and infant age are reported separately - infant age is reported in years and not months since we are unable to indicate two units of measure.
|
|
Age, Continuous
Infants
|
0.51 years
STANDARD_DEVIATION 0.25 • n=91 Participants • Age for one participant dyad is unknown. Mother and infant age are reported separately - infant age is reported in years and not months since we are unable to indicate two units of measure.
|
0.50 years
STANDARD_DEVIATION 0.23 • n=92 Participants • Age for one participant dyad is unknown. Mother and infant age are reported separately - infant age is reported in years and not months since we are unable to indicate two units of measure.
|
0.50 years
STANDARD_DEVIATION 0.24 • n=183 Participants • Age for one participant dyad is unknown. Mother and infant age are reported separately - infant age is reported in years and not months since we are unable to indicate two units of measure.
|
|
Sex: Female, Male
Mothers · Female
|
91 Participants
n=91 Participants • One participant did not report their infant's gender
|
92 Participants
n=92 Participants • One participant did not report their infant's gender
|
183 Participants
n=183 Participants • One participant did not report their infant's gender
|
|
Sex: Female, Male
Mothers · Male
|
0 Participants
n=91 Participants • One participant did not report their infant's gender
|
0 Participants
n=92 Participants • One participant did not report their infant's gender
|
0 Participants
n=183 Participants • One participant did not report their infant's gender
|
|
Sex: Female, Male
Infants · Female
|
44 Participants
n=91 Participants • One participant did not report their infant's gender
|
48 Participants
n=92 Participants • One participant did not report their infant's gender
|
92 Participants
n=183 Participants • One participant did not report their infant's gender
|
|
Sex: Female, Male
Infants · Male
|
47 Participants
n=91 Participants • One participant did not report their infant's gender
|
44 Participants
n=92 Participants • One participant did not report their infant's gender
|
91 Participants
n=183 Participants • One participant did not report their infant's gender
|
|
Ethnicity (NIH/OMB)
Mothers · Hispanic or Latino
|
1 Participants
n=92 Participants • Ethnicity for one mother/infant dyad was not reported
|
4 Participants
n=92 Participants • Ethnicity for one mother/infant dyad was not reported
|
5 Participants
n=184 Participants • Ethnicity for one mother/infant dyad was not reported
|
|
Ethnicity (NIH/OMB)
Mothers · Not Hispanic or Latino
|
90 Participants
n=92 Participants • Ethnicity for one mother/infant dyad was not reported
|
88 Participants
n=92 Participants • Ethnicity for one mother/infant dyad was not reported
|
178 Participants
n=184 Participants • Ethnicity for one mother/infant dyad was not reported
|
|
Ethnicity (NIH/OMB)
Mothers · Unknown or Not Reported
|
1 Participants
n=92 Participants • Ethnicity for one mother/infant dyad was not reported
|
0 Participants
n=92 Participants • Ethnicity for one mother/infant dyad was not reported
|
1 Participants
n=184 Participants • Ethnicity for one mother/infant dyad was not reported
|
|
Ethnicity (NIH/OMB)
Infants · Hispanic or Latino
|
3 Participants
n=92 Participants • Ethnicity for one mother/infant dyad was not reported
|
7 Participants
n=92 Participants • Ethnicity for one mother/infant dyad was not reported
|
10 Participants
n=184 Participants • Ethnicity for one mother/infant dyad was not reported
|
|
Ethnicity (NIH/OMB)
Infants · Not Hispanic or Latino
|
88 Participants
n=92 Participants • Ethnicity for one mother/infant dyad was not reported
|
85 Participants
n=92 Participants • Ethnicity for one mother/infant dyad was not reported
|
173 Participants
n=184 Participants • Ethnicity for one mother/infant dyad was not reported
|
|
Ethnicity (NIH/OMB)
Infants · Unknown or Not Reported
|
1 Participants
n=92 Participants • Ethnicity for one mother/infant dyad was not reported
|
0 Participants
n=92 Participants • Ethnicity for one mother/infant dyad was not reported
|
1 Participants
n=184 Participants • Ethnicity for one mother/infant dyad was not reported
|
|
Race (NIH/OMB)
Mothers · American Indian or Alaska Native
|
0 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
0 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
0 Participants
n=184 Participants • Race for some mothers and infants was not reported
|
|
Race (NIH/OMB)
Mothers · Asian
|
1 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
0 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
1 Participants
n=184 Participants • Race for some mothers and infants was not reported
|
|
Race (NIH/OMB)
Mothers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
0 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
0 Participants
n=184 Participants • Race for some mothers and infants was not reported
|
|
Race (NIH/OMB)
Mothers · Black or African American
|
78 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
84 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
162 Participants
n=184 Participants • Race for some mothers and infants was not reported
|
|
Race (NIH/OMB)
Mothers · White
|
4 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
1 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
5 Participants
n=184 Participants • Race for some mothers and infants was not reported
|
|
Race (NIH/OMB)
Mothers · More than one race
|
4 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
4 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
8 Participants
n=184 Participants • Race for some mothers and infants was not reported
|
|
Race (NIH/OMB)
Mothers · Unknown or Not Reported
|
5 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
3 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
8 Participants
n=184 Participants • Race for some mothers and infants was not reported
|
|
Race (NIH/OMB)
Infants · American Indian or Alaska Native
|
1 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
0 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
1 Participants
n=184 Participants • Race for some mothers and infants was not reported
|
|
Race (NIH/OMB)
Infants · Asian
|
1 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
0 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
1 Participants
n=184 Participants • Race for some mothers and infants was not reported
|
|
Race (NIH/OMB)
Infants · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
0 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
0 Participants
n=184 Participants • Race for some mothers and infants was not reported
|
|
Race (NIH/OMB)
Infants · Black or African American
|
75 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
84 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
159 Participants
n=184 Participants • Race for some mothers and infants was not reported
|
|
Race (NIH/OMB)
Infants · White
|
3 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
1 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
4 Participants
n=184 Participants • Race for some mothers and infants was not reported
|
|
Race (NIH/OMB)
Infants · More than one race
|
6 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
6 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
12 Participants
n=184 Participants • Race for some mothers and infants was not reported
|
|
Race (NIH/OMB)
Infants · Unknown or Not Reported
|
6 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
1 Participants
n=92 Participants • Race for some mothers and infants was not reported
|
7 Participants
n=184 Participants • Race for some mothers and infants was not reported
|
|
Region of Enrollment
United States
|
92 participants
n=92 Participants • Analysis includes infant participants only
|
92 participants
n=92 Participants • Analysis includes infant participants only
|
184 participants
n=184 Participants • Analysis includes infant participants only
|
PRIMARY outcome
Timeframe: 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
Depression symptoms; Patient Health Questionnaire-9; values = 0-27; higher scores = worse outcome
Outcome measures
| Measure |
Mom & Baby Net
n=92 Participants
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
|
Depression & Developmental Awareness System
n=92 Participants
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)
|
|---|---|---|
|
PHQ9
Pre-intervention
|
11.94 score on a scale
Standard Deviation 6.35
|
10.31 score on a scale
Standard Deviation 6.74
|
|
PHQ9
Post-intervention
|
5.61 score on a scale
Standard Deviation 5.60
|
5.33 score on a scale
Standard Deviation 5.85
|
PRIMARY outcome
Timeframe: 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
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);
Outcome measures
| Measure |
Mom & Baby Net
n=92 Participants
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
|
Depression & Developmental Awareness System
n=92 Participants
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)
|
|---|---|---|
|
Landry Parent Child Interaction Rating Scales - Mother Positive Behavior
Pre-Intervention
|
12.43 score on a scale
Standard Deviation 3.72
|
13.16 score on a scale
Standard Deviation 4.02
|
|
Landry Parent Child Interaction Rating Scales - Mother Positive Behavior
Post-Intervention
|
15.54 score on a scale
Standard Deviation 3.10
|
13.04 score on a scale
Standard Deviation 3.94
|
PRIMARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Mom & Baby Net
n=92 Participants
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
|
Depression & Developmental Awareness System
n=92 Participants
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)
|
|---|---|---|
|
Landry Parent Child Interaction Rating Scales - Mother Negative Behavior
Pre-Intervention
|
0.27 score on a scale
Standard Deviation 0.06
|
0.25 score on a scale
Standard Deviation 0.05
|
|
Landry Parent Child Interaction Rating Scales - Mother Negative Behavior
Post-Intervention
|
0.21 score on a scale
Standard Deviation 0.06
|
0.38 score on a scale
Standard Deviation 0.05
|
PRIMARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Mom & Baby Net
n=92 Participants
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
|
Depression & Developmental Awareness System
n=92 Participants
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)
|
|---|---|---|
|
Landry Parent Child Interaction Rating Scales - Child Positive/Engagement Behavior
Pre-Intervention
|
5.21 score on a scale
Standard Deviation 1.94
|
4.97 score on a scale
Standard Deviation 1.99
|
|
Landry Parent Child Interaction Rating Scales - Child Positive/Engagement Behavior
Post-Intervention
|
6.35 score on a scale
Standard Deviation 2.20
|
5.92 score on a scale
Standard Deviation 1.95
|
PRIMARY outcome
Timeframe: 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
Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes: Mother Maintain/Extend (values = 0-100%; higher = better outcomes);
Outcome measures
| Measure |
Mom & Baby Net
n=92 Participants
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
|
Depression & Developmental Awareness System
n=92 Participants
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)
|
|---|---|---|
|
Indicator of Parent Child Interaction (IPCI) - Mother Maintain/Extend
Pre-intervention
|
1.92 percentage of occurrence
Standard Deviation 6.0
|
3.45 percentage of occurrence
Standard Deviation 7.54
|
|
Indicator of Parent Child Interaction (IPCI) - Mother Maintain/Extend
Post-intervention
|
5.83 percentage of occurrence
Standard Deviation 13.02
|
3.66 percentage of occurrence
Standard Deviation 7.22
|
PRIMARY outcome
Timeframe: 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
Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes: Mother Overall Positive (values = 0-100%; higher = better outcomes)
Outcome measures
| Measure |
Mom & Baby Net
n=92 Participants
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
|
Depression & Developmental Awareness System
n=92 Participants
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)
|
|---|---|---|
|
Indicator of Parent Child Interaction (IPCI) - Mother Overall Positive
Pre-intervention
|
29.79 percentage of occurrence
Standard Deviation 15.46
|
30.39 percentage of occurrence
Standard Deviation 18.63
|
|
Indicator of Parent Child Interaction (IPCI) - Mother Overall Positive
Post-intervention
|
39.47 percentage of occurrence
Standard Deviation 18.54
|
33.54 percentage of occurrence
Standard Deviation 15.45
|
PRIMARY outcome
Timeframe: 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
Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes: Child Positive Social (values = 0-100%; higher = better outcomes);
Outcome measures
| Measure |
Mom & Baby Net
n=92 Participants
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
|
Depression & Developmental Awareness System
n=92 Participants
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)
|
|---|---|---|
|
Indicator of Parent Child Interaction (IPCI) - Child Positive Social
Pre-intervention
|
16.50 percentage of occurrence
Standard Deviation 14.83
|
14.82 percentage of occurrence
Standard Deviation 14.29
|
|
Indicator of Parent Child Interaction (IPCI) - Child Positive Social
Post-intervention
|
27.96 percentage of occurrence
Standard Deviation 14.83
|
25.81 percentage of occurrence
Standard Deviation 18.16
|
PRIMARY outcome
Timeframe: 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
Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes: Child Engagement (values = 0-100%; higher = better outcomes)
Outcome measures
| Measure |
Mom & Baby Net
n=92 Participants
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
|
Depression & Developmental Awareness System
n=92 Participants
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)
|
|---|---|---|
|
Indicator of Parent Child Interaction (IPCI) - Child Engagement
Pre-intervention
|
31.14 percentage of occurrence
Standard Deviation 15.89
|
32.70 percentage of occurrence
Standard Deviation 14.40
|
|
Indicator of Parent Child Interaction (IPCI) - Child Engagement
Post-intervention
|
42.44 percentage of occurrence
Standard Deviation 15.09
|
40.56 percentage of occurrence
Standard Deviation 16.78
|
PRIMARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Mom & Baby Net
n=92 Participants
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
|
Depression & Developmental Awareness System
n=92 Participants
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)
|
|---|---|---|
|
Knowledge of Infant Social-Emotional Development and Promotion
Post-intervention
|
14.66 score on a scale
Standard Deviation 0.56
|
8.54 score on a scale
Standard Deviation 0.51
|
|
Knowledge of Infant Social-Emotional Development and Promotion
Pre-intervention
|
8.62 score on a scale
Standard Deviation 0.45
|
8.01 score on a scale
Standard Deviation 0.41
|
Adverse Events
Mom & Baby Net Mothers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Depression & Developmental Awareness System Mothers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mom & Baby Net Infants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Depression & Developmental Awareness System Infants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place