CompletedNot Applicable

Promoting Resilience and Lowering Risk in Early Childhood

United States24 participantsStarted 2022-11-07

Plain-language 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.

Who can participate

Age range

0 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Positive Parenting Practices: EMA Data Positive Parenting Activity Engagement

Timeframe: Daily EMA Data (28 days)

Parenting Behavior: Alabama Parenting Questionnaire- Positive Parenting Subscale

Timeframe: Change from baseline to post-intervention

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

Timeframe: Daily EMA Data (28 days)

Helped me Interact Positively With Child

Timeframe: Post-intervention Assessment

Interest in Using the App in the Future

Timeframe: Post-Intervention Assessment

Recommend the App to a Friend

Timeframe: Post-Intervention Assessment

Trial details

NCT IDNCT05479734

SponsorUniversity of Oklahoma

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-12

Results submitted2024-09-24

View on ClinicalTrials.gov More Child Abuse trials

Plain-language summary

Who can participate

Age range

0 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Positive Parenting Practices: EMA Data Positive Parenting Activity Engagement

Timeframe: Daily EMA Data (28 days)

Parenting Behavior: Alabama Parenting Questionnaire- Positive Parenting Subscale

Timeframe: Change from baseline to post-intervention

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

Timeframe: Daily EMA Data (28 days)

Helped me Interact Positively With Child

Timeframe: Post-intervention Assessment

Interest in Using the App in the Future

Timeframe: Post-Intervention Assessment

Recommend the App to a Friend

Timeframe: Post-Intervention Assessment