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Clinical Trials/NCT05479734
NCT05479734
Completed
N/A

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

University of Oklahoma1 site in 1 country24 target enrollmentNovember 7, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Child Abuse
Sponsor
University of Oklahoma
Enrollment
24
Locations
1
Primary Endpoint
Positive Parenting Practices: EMA Data Positive Parenting Activity Engagement
Status
Completed
Last Updated
6 months ago

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
November 7, 2022
End Date
June 12, 2023
Last Updated
6 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Positive Parenting Practices: EMA Data Positive Parenting Activity Engagement

Time Frame: Daily EMA Data (28 days)

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.

Parenting Behavior: Alabama Parenting Questionnaire- Positive Parenting Subscale

Time Frame: Change from baseline to post-intervention

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).

Recommend the App to a Friend

Time Frame: Post-Intervention Assessment

Participants responded on a scale from Extremely unlikely (scored -3) to Extremely likely (scored 3).

Positive Parenting Practices: EMA Data Time Spent With Child Daily (in Hours)

Time Frame: Daily EMA Data (28 days)

Mean number of hours spent with the child daily during the periods with and without app-delivered parenting tips.

Helped me Interact Positively With Child

Time Frame: Post-intervention Assessment

Participants responded on a scale from Not at all helpful (scored -1) to Extremely helpful (scored 3).

Interest in Using the App in the Future

Time Frame: Post-Intervention Assessment

Participants responded on a scale from Not at all interested (scored -1) to Extremely interested (scored 3).

Secondary Outcomes

  • General Child Development Score(Change from baseline to post-intervention)
  • Child Behavior: EMA Challenging Child Behaviors(Daily EMA Data (28 days))
  • Child Behavior: EMA Positive Child Behaviors(Daily EMA Data (28 days))

Study Sites (1)

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