Clinical trial NCT05479734: Promoting Resilience and Lowering Risk in Early Childhood
Official title: Promoting Resilience and Lowering Risk in Early Childhood: An mHealth Intervention Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Child Abuse
Child Neglect
Parenting
Child Development
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 26
Sex: ALL
Minimum age (years): 0
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Positive Parenting Practices: EMA Data Positive Parenting Practices
timeFrame: Daily EMA Data (28 days)
measure: Positive Parenting Practices: Positive Parenting Practices Questionnaire
timeFrame: Change from baseline to follow-up (1-3 months post-intervention)
measure: Parenting Behavior: Alabama Parenting Questionnaire
timeFrame: Change from baseline to follow-up (1-3 months post-intervention)
measure: Parenting Behavior: Parenting Interactions with Children: Checklist of Observations Linked to Outcomes
timeFrame: Change from baseline to follow-up (1-3 months post-intervention)
measure: Parenting Behavior: EMA Data on Parent Response to Child Positive and Negative Behavior
timeFrame: Daily EMA Data (28 days)
measure: Parent Satisfaction with App: Ease of Use and Satisfaction Survey
timeFrame: Last Day of EMA Data Collection
Secondary outcomes:
measure: Parenting Stress: Parenting Stress Index- Short Form
timeFrame: Change from baseline to follow-up (1-3 months post-intervention)
measure: Child Development
timeFrame: Change from baseline to follow-up (1-3 months post-intervention)
measure: Child Development:
timeFrame: Change from baseline to follow-up (1-3 months post-intervention)
measure: Child Behavior: EMA Data Positive and Negative Behaviors
timeFrame: Daily EMA Data (28 days)
measure: Child Adversity Exposure: Parent-Child Conflict Scale
timeFrame: Change from baseline to follow-up (1- 3 months post-intervention)
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center- Center on Child Abuse and Neglect
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: David Bard, PhD
role: PRINCIPAL_INVESTIGATOR
References: