Promoting Resilience and Lowering Risk in Early Childhood

NCT ID: NCT05479734

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-07
• Study Completion Date: 2023-06-12

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.

Conditions

Child Abuse; Child Neglect; Parenting; Child Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

mHealth Intervention

Intervention Type: BEHAVIORAL

A smartphone app (mHealth app) will deliver daily tailored messages with tips on monitoring and promoting child development and positive parenting tips.

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.

Group Type: EXPERIMENTAL

mHealth Intervention

Intervention Type: BEHAVIORAL

A smartphone app (mHealth app) will deliver daily tailored messages with tips on monitoring and promoting child development and positive parenting tips.

Interventions

mHealth Intervention

A smartphone app (mHealth app) will deliver daily tailored messages with tips on monitoring and promoting child development and positive parenting tips.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Bard, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

University of Oklahoma Health Science Center- Center on Child Abuse and Neglect

Oklahoma City, Oklahoma, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

13549

Identifier Type: -

Identifier Source: org_study_id