Trial Outcomes & Findings for Promoting Resilience and Lowering Risk in Early Childhood (NCT NCT05479734)
NCT ID: NCT05479734
Last Updated: 2025-10-14
Results Overview
Participants select the positive parenting activities they engaged in with their child each day during the EMA study (0 is the lowest and represents no engagement in positive parenting practices and a higher number reflects more activities reported). Analyses compared average activity counts during periods with and without app-delivered parenting tips.
COMPLETED
NA
24 participants
Daily EMA Data (28 days)
2025-10-14
Participant Flow
Recruitment of clients involved the assistance of up to 3 home visiting agencies in two urban counties in the SW U.S. All agencies were participating in a quality improvement network focused on developmental monitoring and promotion. Agencies that elected to design QI projects that promoted the study parenting app were asked to deliver an initial study pitch to willing and eligible clients. Clients that opted-in were later contacted by the study team for more comprehensive study recruitment.
Participant milestones
| Measure |
No Parenting Tip, Then Parenting Tips
This group is asked to complete a daily survey using the mHealth smartphone app (mHealth app) for the first 14 days of participation. The group will then receive twice daily (once in the morning and once in the evening) parenting tips (tailored messages with tips on monitoring and promoting child development) within the app for another 14 days. Participants continue to complete a daily evening survey during the days they receive parenting tips.
|
Parenting Tips, Then no Parenting Tips
The group will receive twice daily (once in the morning and once in the evening) parenting tips (tailored messages with tips on monitoring and promoting child development) within the mHealth smartphone app (mHealth app) for the first 14 days. Participants will also complete a daily evening survey during the days they receive parenting tips. Starting on the 15th day, this group is only asked to complete a daily survey (parenting tips are no longer delivered) using the mHealth smartphone app for another 14 days of participation.
|
|---|---|---|
|
Baseline Assessment
STARTED
|
11
|
13
|
|
Baseline Assessment
COMPLETED
|
11
|
13
|
|
Baseline Assessment
NOT COMPLETED
|
0
|
0
|
|
Week 1 App Use (1+ Survey and/or Tips)
STARTED
|
11
|
13
|
|
Week 1 App Use (1+ Survey and/or Tips)
COMPLETED
|
10
|
13
|
|
Week 1 App Use (1+ Survey and/or Tips)
NOT COMPLETED
|
1
|
0
|
|
Week 2 App Use (1+ Survey and/or Tips)
STARTED
|
11
|
13
|
|
Week 2 App Use (1+ Survey and/or Tips)
COMPLETED
|
11
|
13
|
|
Week 2 App Use (1+ Survey and/or Tips)
NOT COMPLETED
|
0
|
0
|
|
Week 3 App Use (1+ Survey and/or Tips)
STARTED
|
11
|
13
|
|
Week 3 App Use (1+ Survey and/or Tips)
COMPLETED
|
11
|
10
|
|
Week 3 App Use (1+ Survey and/or Tips)
NOT COMPLETED
|
0
|
3
|
|
Week 4 App Use (1+ Survey and/or Tips)
STARTED
|
11
|
13
|
|
Week 4 App Use (1+ Survey and/or Tips)
COMPLETED
|
11
|
8
|
|
Week 4 App Use (1+ Survey and/or Tips)
NOT COMPLETED
|
0
|
5
|
|
Post-Intervention Assessment
STARTED
|
11
|
13
|
|
Post-Intervention Assessment
COMPLETED
|
11
|
12
|
|
Post-Intervention Assessment
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
No Parenting Tip, Then Parenting Tips
This group is asked to complete a daily survey using the mHealth smartphone app (mHealth app) for the first 14 days of participation. The group will then receive twice daily (once in the morning and once in the evening) parenting tips (tailored messages with tips on monitoring and promoting child development) within the app for another 14 days. Participants continue to complete a daily evening survey during the days they receive parenting tips.
|
Parenting Tips, Then no Parenting Tips
The group will receive twice daily (once in the morning and once in the evening) parenting tips (tailored messages with tips on monitoring and promoting child development) within the mHealth smartphone app (mHealth app) for the first 14 days. Participants will also complete a daily evening survey during the days they receive parenting tips. Starting on the 15th day, this group is only asked to complete a daily survey (parenting tips are no longer delivered) using the mHealth smartphone app for another 14 days of participation.
|
|---|---|---|
|
Week 1 App Use (1+ Survey and/or Tips)
No app interactions logged
|
1
|
0
|
|
Week 3 App Use (1+ Survey and/or Tips)
No app interactions logged
|
0
|
3
|
|
Week 4 App Use (1+ Survey and/or Tips)
No app interactions logged
|
0
|
5
|
|
Post-Intervention Assessment
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Promoting Resilience and Lowering Risk in Early Childhood
Baseline characteristics by cohort
| Measure |
No Parenting Tip, Then Parenting Tips
n=11 Participants
In this crossover arm, participants are assigned to an EMA Only condition for the first two weeks (14 days) of study involvement. During this time, parents receiving daily alerts to complete an ecological momentary assessment (EMA) that asks participants to provide information on recent parent-child interactions, current stressors or challenges, and their child's emotional and behavioral functioning. For the last two weeks of study involvement (days 15 through 28), this group continues to complete the once-daily EMA survey, but they also receive app-delivered parenting tips twice daily. While in this condition phase, a tip notification is delivered to the participant's mobile phone once in the morning and once in the evening. Participants must click on the notification to reveal the parenting tip within the app interface.
mHealth Intervention: A smartphone app (mHealth app) will deliver daily tailored messages with tips on monitoring and promoting child development and positive parenting tips.
|
Parenting Tips, Then no Parenting Tips
n=13 Participants
In this crossover arm, participants are assigned to the EMA + mHealth intervention (i.e., app-delivered parenting tips twice daily) condition for the first two weeks (14 days) of study involvement. During this time, parents receiving daily alerts to complete an ecological momentary assessment (EMA) that asks participants to provide information on recent parent-child interactions, current stressors or challenges, and their child's emotional and behavioral functioning. During this time, a tip notification is also delivered to the participant's mobile phone once in the morning and once in the evening. Participants must click on the notification to reveal the parenting tip within the app interface. For the last two weeks of study involvement (days 15 through 28), this group continues to complete the once-daily EMA survey, but the parenting tips are no longer delivered.
mHealth Intervention: A smartphone app (mHealth app) will deliver daily tailored messages with tips on monitoring and promoting child development and positive parenting tips.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.5 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
31.0 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
31.7 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
13 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Daily EMA Data (28 days)Population: Three participants did not provide data on this measure during their No Parenting Tips period.
Participants select the positive parenting activities they engaged in with their child each day during the EMA study (0 is the lowest and represents no engagement in positive parenting practices and a higher number reflects more activities reported). Analyses compared average activity counts during periods with and without app-delivered parenting tips.
Outcome measures
| Measure |
No Parenting Tips
n=21 Participants
Represents period of time when participants were not receiving the parenting tips through the app.
|
Receiving Parenting Tips
n=24 Participants
Represents period of time when participants were receiving parenting tips through the app.
|
|---|---|---|
|
Positive Parenting Practices: EMA Data Positive Parenting Activity Engagement
|
3.75 Daily number of activities
Standard Error 0.25
|
2.38 Daily number of activities
Standard Error 0.24
|
PRIMARY outcome
Timeframe: Change from baseline to post-interventionPopulation: As explained under Study Design, some outcomes were only measured at pre- and post-intervention assessment points and, therefore, only allow for classic within-group pre-post change analyses. This restriction applies to this outcome; thus, no test for differences between the experimental arms was conducted. Also, 1 participant skipped too many items at baseline, and a subscale calculation was not warranted. 1 participant did not complete the post-intervention assessment (lost to follow-up).
The Alabama Parenting Questionnaire contains 3 subscales previously used with parents of young children that represent different dimensions of parenting. Each item is rated on a 1 (never) to 5 (always) Likert scale. A higher score on each subscale represents more engagement in that parenting behavior. This analysis focused on the Positive Parenting Subscale (12 items; score range: 12-60).
Outcome measures
| Measure |
No Parenting Tips
n=23 Participants
Represents period of time when participants were not receiving the parenting tips through the app.
|
Receiving Parenting Tips
n=23 Participants
Represents period of time when participants were receiving parenting tips through the app.
|
|---|---|---|
|
Parenting Behavior: Alabama Parenting Questionnaire- Positive Parenting Subscale
|
47.6 Units on a scale
Standard Error 1.28
|
47.6 Units on a scale
Standard Error 1.28
|
PRIMARY outcome
Timeframe: Daily EMA Data (28 days)Population: Three participants did not complete EMA assessments during their No Parenting Tips period.
Mean number of hours spent with the child daily during the periods with and without app-delivered parenting tips.
Outcome measures
| Measure |
No Parenting Tips
n=21 Participants
Represents period of time when participants were not receiving the parenting tips through the app.
|
Receiving Parenting Tips
n=24 Participants
Represents period of time when participants were receiving parenting tips through the app.
|
|---|---|---|
|
Positive Parenting Practices: EMA Data Time Spent With Child Daily (in Hours)
|
2.82 Daily number of hours
Standard Error 0.07
|
2.72 Daily number of hours
Standard Error 0.07
|
PRIMARY outcome
Timeframe: Post-intervention AssessmentPopulation: As explained under Study Design, feasibility and usability outcomes were only measured at post-intervention and were analyzed with one-sample Wilcoxon signed rank tests to detect moderate or greater levels of feasibility/utility. This restriction applies to this outcome; thus, no test for differences between the experimental arms was conducted. Also, 1 participant skipped this item at the post assessment. 1 participant did not complete the post-assessment (lost to follow-up).
Participants responded on a scale from Not at all helpful (scored -1) to Extremely helpful (scored 3).
Outcome measures
| Measure |
No Parenting Tips
n=22 Participants
Represents period of time when participants were not receiving the parenting tips through the app.
|
Receiving Parenting Tips
Represents period of time when participants were receiving parenting tips through the app.
|
|---|---|---|
|
Helped me Interact Positively With Child
|
1.64 Units on a scale
Standard Deviation 1.18
|
—
|
PRIMARY outcome
Timeframe: Post-Intervention AssessmentPopulation: As explained under Study Design, feasibility and usability outcomes were only measured at post-intervention and were analyzed with one-sample Wilcoxon signed rank tests to detect moderate or greater levels of feasibility/utility. This restriction applies to this outcome; thus, no test for differences between the experimental arms was conducted. Also, 1 participant skipped this item. 1 participant did not complete the post-assessment (lost to follow-up).
Participants responded on a scale from Not at all interested (scored -1) to Extremely interested (scored 3).
Outcome measures
| Measure |
No Parenting Tips
n=22 Participants
Represents period of time when participants were not receiving the parenting tips through the app.
|
Receiving Parenting Tips
Represents period of time when participants were receiving parenting tips through the app.
|
|---|---|---|
|
Interest in Using the App in the Future
|
1.41 Units on a scale
Standard Deviation 1.26
|
—
|
PRIMARY outcome
Timeframe: Post-Intervention AssessmentPopulation: As explained under Study Design, feasibility and usability outcomes were only measured at post-intervention and were analyzed with one-sample Wilcoxon signed rank tests to detect moderate or greater levels of feasibility/utility. This restriction applies to this outcome; thus, no test for differences between the experimental arms was conducted. 1 participant did not complete the post-assessment (lost to follow-up).
Participants responded on a scale from Extremely unlikely (scored -3) to Extremely likely (scored 3).
Outcome measures
| Measure |
No Parenting Tips
n=23 Participants
Represents period of time when participants were not receiving the parenting tips through the app.
|
Receiving Parenting Tips
Represents period of time when participants were receiving parenting tips through the app.
|
|---|---|---|
|
Recommend the App to a Friend
|
1.48 Units on a scale
Standard Deviation 1.81
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to post-interventionPopulation: As explained under Study Design, some outcomes were only measured at pre- and post-intervention assessment points and, therefore, only allow for classic within-group pre-post change analyses. This restriction applies to this outcome; thus, no test for differences between the experimental arms was conducted. 1 participant did not complete the post-intervention assessment (lost to follow-up).
Developmental Profiles-4 parent/caregiver interview contains five subscales: social-emotional, physical, communication, cognitive, and adaptive behavior. Each subscale score is age standardized with an average of 100 and a standard deviation of 15 (minimum score of 40, maximum score of 160). The General Development Score used in this analysis represents a standardized composite of the 5 subscale scores (minimum score of 46, maximum score of 150). A higher composite score indicates more advanced child development.
Outcome measures
| Measure |
No Parenting Tips
n=24 Participants
Represents period of time when participants were not receiving the parenting tips through the app.
|
Receiving Parenting Tips
n=23 Participants
Represents period of time when participants were receiving parenting tips through the app.
|
|---|---|---|
|
General Child Development Score
|
99.6 Units on a scale
Standard Error 3.92
|
101.0 Units on a scale
Standard Error 3.94
|
SECONDARY outcome
Timeframe: Daily EMA Data (28 days)Population: Three participants did not provide EMA data during the No Parenting Tips period.
Parents report the number of challenging (difficult to manage) child behaviors daily. Analyses compared average behavior counts during periods with and without app-delivered parenting tips.
Outcome measures
| Measure |
No Parenting Tips
n=21 Participants
Represents period of time when participants were not receiving the parenting tips through the app.
|
Receiving Parenting Tips
n=24 Participants
Represents period of time when participants were receiving parenting tips through the app.
|
|---|---|---|
|
Child Behavior: EMA Challenging Child Behaviors
|
0.50 Daily number of challenging behaviors
Standard Error 0.06
|
0.33 Daily number of challenging behaviors
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Daily EMA Data (28 days)Population: Three participants did not provide EMA data during the No Parenting Tips period.
Parents report the number of positive ("good") child behaviors daily. Analyses compared average behavior counts during periods with and without app-delivered parenting tips.
Outcome measures
| Measure |
No Parenting Tips
n=21 Participants
Represents period of time when participants were not receiving the parenting tips through the app.
|
Receiving Parenting Tips
n=24 Participants
Represents period of time when participants were receiving parenting tips through the app.
|
|---|---|---|
|
Child Behavior: EMA Positive Child Behaviors
|
2.54 Daily number of positive behaviors
Standard Error 0.13
|
2.21 Daily number of positive behaviors
Standard Error 0.13
|
Adverse Events
No Parenting Tip, Then Parenting Tips
Parenting Tips, Then no Parenting Tips
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
David Bard, Director of EmBRACER Center
University of Oklahoma Health Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place