Promoting Resilience and Lowering Risk in Early Childhood

NCT05479734 | Completed Results

• 1 other identifier: 13549
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Abuse; Child Neglect; Parenting; Child Development

Outcome Measures

Primary Outcomes (6)

• Positive Parenting Practices: EMA Data Positive Parenting Activity Engagement

  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.

  Daily EMA Data (28 days)

• Parenting Behavior: Alabama Parenting Questionnaire- Positive Parenting Subscale

  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).

  Change from baseline to post-intervention

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

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

  Daily EMA Data (28 days)

• Helped me Interact Positively With Child

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

  Post-intervention Assessment

• Interest in Using the App in the Future

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

  Post-Intervention Assessment

• Recommend the App to a Friend

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

  Post-Intervention Assessment

Secondary Outcomes (3)

• 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 Arms (2)

No parenting tip, then parenting tips

EXPERIMENTAL

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.

Behavioral: mHealth Intervention

Parenting tips, then no parenting tips

EXPERIMENTAL

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.

Behavioral: mHealth Intervention

Interventions

mHealth Intervention BEHAVIORAL

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

No parenting tip, then parenting tips; Parenting tips, then no parenting tips

Eligibility Criteria

• Age: 0 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any new or currently enrolled parent in Oklahoma or Tulsa County in MIECHV-funded home visiting programs.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

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

Oklahoma City, Oklahoma, 73104, United States

Location

Results Point of Contact

• Title: David Bard, Director of EmBRACER Center
• Organization: University of Oklahoma Health Sciences

David-Bard@ouhsc.edu

4052718001

Study Officials

• David Bard, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The statistical model is outcome dependent. Some outcomes were measured at pre-intervention, mid-intervention, and post-intervention assessment points allowing for classic crossover study design analyses of intervention arm differences. Other outcomes were only measured at pre-intervention and post-intervention assessment points and allow for classic within-group pre-post change analyses. Feasibility and usability outcomes were effectively measured at post-intervention only and were analyzed with one-sample Wilcoxon signed rank tests to detect moderate or greater levels of feasibility/utility.

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 29, 2022
• Study Start: November 7, 2022
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: October 14, 2025
• Results First Posted: October 14, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)