Promoting Resilience and Lowering Risk in Early Childhood

Study Overview
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Brief Summary
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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.

Detailed Description
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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 with the mHealth app and individual characteristics of parents and families (e.g., age of child, level of adversity exposure) will predict app utilization outcomes. 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 on days when they do not receive this content. 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 greater emotional and behavioral functioning on days when their parents report more positive parenting practices. Hypothesis 2b. Children of parents who report greater daily engagement in positive parenting practices will achieve higher levels of development at the follow-up assessment relative to children of parents who report lower daily levels of positive parenting practices.

Official Title
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Promoting Resilience and Lowering Risk in Early Childhood: An mHealth Intervention Study

Conditions
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Child Abuse, Child Neglect, Parenting, Child Development

Intervention / Treatment
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* Behavioral: mHealth Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any new or currently enrolled parent in Oklahoma or Tulsa County in MIECHV-funded home visiting programs. Exclusion Criteria: Parents residing outside of Oklahoma or Tulsa Counties will not be recruited (although if they move to another county between baseline and follow-up, they may be eligible to complete the follow-up survey at the discretion of the Principal Investigator). Parents who cannot read/speak English or Spanish at an 8th-grade level or higher will not be recruited. Parents under age 16 will not be recruited. Parents ages 16-17 meeting other eligibility requirements may be recruited using the assent form with signatures from both of his/her parents.

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mHealth Intervention + EMA<br>When families are in the mHealth intervention condition, the mHealth app will deliver parenting tips and strategies daily for 14 days. Furthermore, we plan to administer brief surveys via the mHealth app twice once a day at a pre-determined time. These surveys will ask parents to provide information about where they are and with whom, their emotional state, any recent parent-child interactions, and any current stressors or challenges. Parents will receive these daily surveys and the parenting tips for every day for two weeks. Then they will switch to EMA Only + Services As Usual. | Behavioral: mHealth Intervention<br>* A smartphone app (mHealth app) will deliver daily tailored messages with tips on monitoring and promoting child development and positive parenting tips.<br>|
| No Intervention: EMA Only+ Services As Usual<br>In the EMA only condition, families will continue to receive services utilizing the home visiting model for the program they are enrolled in, including modules on healthy parent-child interaction and promoting parenting skills in high-risk families, but they will not receive parenting tips via the mHealth app during this period (2 weeks). Then, they will switch to mHealth Intervention + EMA. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Parenting Practices: EMA Data Positive Parenting Practices | Participants select the positive parenting practices 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 higher number represent more activities reported) | Daily EMA Data (28 days) | 
| Positive Parenting Practices: Positive Parenting Practices Questionnaire | Self-report questionnaire in which caregivers select how many days a week they engage in 15 different positive parenting practices with their child. ( Items are rated on a Likert scale 0 (never) to 7 (everyday) with 0 being the lowest score and 105 being the maximum total score and higher scores represent higher reported engagement in positive parenting practices) | Change from baseline to follow-up (1-3 months post-intervention) | 
| Parenting Behavior: Alabama Parenting Questionnaire | The Alabama Parenting Questionnaire consists of 5 subscales 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. The subscales are: Poor Monitoring (10 items (score range: 0-50)); Corporal Punishments (3 items (score range: 0-15)); Positive Parenting (6 items (score range: 0-30); Involvement (10 items (scoring range: 0-50)); Inconsistent Discipline (5 items (scoring range: 0-25)) | Change from baseline to follow-up (1-3 months post-intervention) | 
| Parenting Behavior: Parenting Interactions with Children: Checklist of Observations Linked to Outcomes | Checklist of 29 observable developmentally supportive parenting behaviors in four domains (affection, responsiveness, encouragement, and teaching) 0 is the lowest and 29 is the highest, with higher scores representing more behaviors observed. | Change from baseline to follow-up (1-3 months post-intervention) | 
| Parenting Behavior: EMA Data on Parent Response to Child Positive and Negative Behavior | Parents report how they responded to their child's positive and negative behavior during each day of the EMA study | Daily EMA Data (28 days) | 
| Parent Satisfaction with App: Ease of Use and Satisfaction Survey | 12-item survey that parents complete about the ease of use and their satisfaction with the mHealth App (scores range from 0-58, with a higher score representing higher satisfaction) | Last Day of EMA Data Collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parenting Stress: Parenting Stress Index- Short Form | 36-item measure divided into 3 domains: Parental Distress; Parent-Child Dysfunctional Interaction; and Difficult Child. These are summed together to create the Total Stress scale. Each item is rated on a 1 (strongly agree) to 5 (strongly disagree) scale. The scoring can range from 24-180, with lower scores representing higher parenting stress. | Change from baseline to follow-up (1-3 months post-intervention) | 
| Child Development | Ages and Stages- 3 | Change from baseline to follow-up (1-3 months post-intervention) | 
| Child Development: | Developmental Profiles- 4 | Change from baseline to follow-up (1-3 months post-intervention) | 
| Child Behavior: EMA Data Positive and Negative Behaviors | Parents report the number of positive and negative behaviors their child engages in and what the behaviors are each day of EMA study. | Daily EMA Data (28 days) | 
| Child Adversity Exposure: Parent-Child Conflict Scale | 23-item measure parent-report measure that provides information regarding the presence and severity of parenting behaviors associated with child maltreatment. Each item is scored on a 0 (never) to 7 (more than 20 times in past 6 months) Total score can range 0-161 with higher scores representing higher presence of parenting behaviors associated with child maltreatment. | Change from baseline to follow-up (1- 3 months post-intervention) |