Promoting Resilience and Lowering Risk in Early Childhood

Not Applicable

Completed

Conditions: Child Neglect
Parenting
Child Abuse
Child Development

Registration Number: NCT05479734

Lead Sponsor: University of Oklahoma

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Positive Parenting Practices: EMA Data Positive Parenting Activity Engagement	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	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	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)	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	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	Post-Intervention Assessment	Participants responded on a scale from Not at all interested (scored -1) to Extremely interested (scored 3).

Secondary Outcome Measures

Name	Time	Method
General Child Development Score	Change from baseline to post-intervention	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.
Child Behavior: EMA Challenging Child Behaviors	Daily EMA Data (28 days)	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.
Child Behavior: EMA Positive Child Behaviors	Daily EMA Data (28 days)	Parents report the number of positive ("good") child behaviors daily. Analyses compared average behavior counts during periods with and without app-delivered parenting tips.

Trial Locations

Locations (1): University of Oklahoma Health Science Center- Center on Child Abuse and Neglect
🇺🇸
Oklahoma City, Oklahoma, United States
University of Oklahoma Health Science Center- Center on Child Abuse and Neglect
🇺🇸Oklahoma City, Oklahoma, United States