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An intervention study to provide in-the-moment parenting tips with the goal of increasing healthy parent-child interactions leading to resiliency in high-risk children. Specifically, in a sample of parents participating in HV programs, the investigators will use a smartphone app (mHealth app) to deliver daily tailored messages with tips on monitoring and promoting child development. Daily assessments of parents' emotions, parenting behaviors, and interactions with their children will also be collected via the app. During the 4-week EMA study, parents will receive either 2 weeks of the mHealth intervention + EMA data collection followed by 2 weeks of only EMA data collection or to receive 2 weeks of only EMA data collection followed by 2 weeks of mHealth intervention + EMA data collection.
This is an intervention study to provide in-the-moment parenting tips with the goal of educating parents about monitoring and promoting child development, thereby increasing healthy parent-child interactions leading to resiliency in high-risk children. Specifically, in a sample of parents participating in a HV program, the investigators will use a smartphone app (mHealth app) to deliver twice-daily tailored messages with tips on monitoring and promoting child development. Ecological momentary assessments (EMA) of parents' emotions, parenting behaviors, and interactions with their children will also be collected via the mHealth app. Building off previous work the investigators expect that parents will evidence greater engagement in positive parenting practices on days when they receive the mobile-based parenting tips and strategies relative to on days when they do not receive this content.
The investigators hypothesize that in-the-moment parenting tips delivered around peak times of parent-child interactions (i.e., before work/school, mealtimes, and bedtime) will promote positive parenting practices in a sample of parents at increased risk of adversity exposure. The investigators aim to use EMA methodology to measure both group level differences (i.e., intervention vs. services as usual) and within-person fluctuations in harsh parenting, children's emotional and behavioral functioning, and positive parenting practices. The study will evaluate the following aims and hypotheses:
Aim 1. Conduct a 2-arm, randomized, controlled crossover trial to examine the feasibility and effectiveness of a mobile-based parenting app with parents participating in HV services.
Hypothesis 1a. Parents will report high rates of satisfaction and usability. Hypothesis 1b. Parents will evidence greater engagement in positive parenting practices on days when they receive the mobile-based parenting tips and strategies relative to days when they do not receive this content.
Hypothesis 1c. Groups will evidence increases in positive parenting subscale scores after a month of app engagement.
Aim 2. Utilize EMA data and follow-up assessments to examine the impact of positive parenting practices on the promotion of child development.
Hypothesis 2a. Children will demonstrate less challenging and more positive behavioral functioning on days when their parents receive positive parenting tips.
Hypothesis 2b. Groups will evidence increases in developmental scores after a month of app engagement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No parenting tip, then parenting tips | Experimental | 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. |
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| Parenting tips, then no parenting tips | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mHealth Intervention | Behavioral | A smartphone app (mHealth app) will deliver daily tailored messages with tips on monitoring and promoting child development and positive parenting tips. |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Parenting Practices: EMA Data Positive Parenting Activity Engagement | 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. | Daily EMA Data (28 days) |
| Parenting Behavior: Alabama Parenting Questionnaire- Positive Parenting Subscale | 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). | Change from baseline to post-intervention |
| Positive Parenting Practices: EMA Data Time Spent With Child Daily (in Hours) | Mean number of hours spent with the child daily during the periods with and without app-delivered parenting tips. | Daily EMA Data (28 days) |
| Helped me Interact Positively With Child | Participants responded on a scale from Not at all helpful (scored -1) to Extremely helpful (scored 3). | Post-intervention Assessment |
| Interest in Using the App in the Future | Participants responded on a scale from Not at all interested (scored -1) to Extremely interested (scored 3). | Post-Intervention Assessment |
| Recommend the App to a Friend |
| Measure | Description | Time Frame |
|---|---|---|
| General Child Development Score | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Bard, PhD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Science Center- Center on Child Abuse and Neglect | Oklahoma City | Oklahoma | 73104 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Assessment |
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| Week 1 App Use (1+ Survey and/or Tips) |
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| Week 2 App Use (1+ Survey and/or Tips) |
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| Week 3 App Use (1+ Survey and/or Tips) |
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| Week 4 App Use (1+ Survey and/or Tips) |
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| Post-Intervention Assessment |
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| ID | Title | Description |
|---|---|---|
| BG000 | No Parenting Tip, Then Parenting Tips | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Positive Parenting Practices: EMA Data Positive Parenting Activity Engagement | 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. | Three participants did not provide data on this measure during their No Parenting Tips period. | Posted | Least Squares Mean | Standard Error | Daily number of activities | Daily EMA Data (28 days) |
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Participants were followed for up to 3 months as they completed a baseline assessment, 1 month of app interaction, and a post-intervention assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Bard, Director of EmBRACER Center | University of Oklahoma Health Sciences | 4052718001 | David-Bard@ouhsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2022 | Sep 24, 2024 | Prot_SAP_000.pdf |
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The statistical model is outcome dependent. Some outcomes were measured at pre-intervention, mid-intervention, and post-intervention assessment points allowing for classic crossover study design analyses of intervention arm differences. Other outcomes were only measured at pre-intervention and post-intervention assessment points and allow for classic within-group pre-post change analyses. Feasibility and usability outcomes were effectively measured at post-intervention only and were analyzed with one-sample Wilcoxon signed rank tests to detect moderate or greater levels of feasibility/utility.
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Participants responded on a scale from Extremely unlikely (scored -3) to Extremely likely (scored 3). |
| Post-Intervention Assessment |
| Change from baseline to post-intervention |
| Child Behavior: EMA Challenging Child Behaviors | 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. | Daily EMA Data (28 days) |
| Child Behavior: EMA Positive Child Behaviors | Parents report the number of positive ("good") child behaviors daily. Analyses compared average behavior counts during periods with and without app-delivered parenting tips. | Daily EMA Data (28 days) |
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| BG001 | Parenting Tips, Then no Parenting Tips | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Receiving Parenting Tips |
Represents period of time when participants were receiving parenting tips through the app. |
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| Primary | Parenting Behavior: Alabama Parenting Questionnaire- Positive Parenting Subscale | 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). | 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). | Posted | Least Squares Mean | Standard Error | Units on a scale | Change from baseline to post-intervention |
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| Primary | Positive Parenting Practices: EMA Data Time Spent With Child Daily (in Hours) | Mean number of hours spent with the child daily during the periods with and without app-delivered parenting tips. | Three participants did not complete EMA assessments during their No Parenting Tips period. | Posted | Least Squares Mean | Standard Error | Daily number of hours | Daily EMA Data (28 days) |
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| Primary | Helped me Interact Positively With Child | Participants responded on a scale from Not at all helpful (scored -1) to Extremely helpful (scored 3). | 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). | Posted | Mean | Standard Deviation | Units on a scale | Post-intervention Assessment |
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| Primary | Interest in Using the App in the Future | Participants responded on a scale from Not at all interested (scored -1) to Extremely interested (scored 3). | 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). | Posted | Mean | Standard Deviation | Units on a scale | Post-Intervention Assessment |
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| Primary | Recommend the App to a Friend | Participants responded on a scale from Extremely unlikely (scored -3) to Extremely likely (scored 3). | 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). | Posted | Mean | Standard Deviation | Units on a scale | Post-Intervention Assessment |
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| Secondary | General Child Development Score | 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. | 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). | Posted | Least Squares Mean | Standard Error | Units on a scale | Change from baseline to post-intervention |
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| Secondary | Child Behavior: EMA Challenging Child Behaviors | 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. | Three participants did not provide EMA data during the No Parenting Tips period. | Posted | Least Squares Mean | Standard Error | Daily number of challenging behaviors | Daily EMA Data (28 days) |
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| Secondary | Child Behavior: EMA Positive Child Behaviors | Parents report the number of positive ("good") child behaviors daily. Analyses compared average behavior counts during periods with and without app-delivered parenting tips. | Three participants did not provide EMA data during the No Parenting Tips period. | Posted | Least Squares Mean | Standard Error | Daily number of positive behaviors | Daily EMA Data (28 days) |
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
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| Superiority |
Expected Outcomes: greater number of behaviors while receiving parenting tips. |