- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05479734
Promoting Resilience and Lowering Risk in Early Childhood
Promoting Resilience and Lowering Risk in Early Childhood: An mHealth Intervention Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Science Center- Center on Child Abuse and Neglect
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
A smartphone app (mHealth app) will deliver daily tailored messages with tips on monitoring and promoting child development and positive parenting tips.
|
|
Experimental: 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.
|
A smartphone app (mHealth app) will deliver daily tailored messages with tips on monitoring and promoting child development and positive parenting tips.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Daily EMA Data (28 days)
|
|
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).
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Change from baseline to post-intervention
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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.
|
Daily EMA Data (28 days)
|
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Helped me Interact Positively With Child
Time Frame: Post-intervention Assessment
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Participants responded on a scale from Not at all helpful (scored -1) to Extremely helpful (scored 3).
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Post-intervention Assessment
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Interest in Using the App in the Future
Time Frame: Post-Intervention Assessment
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Participants responded on a scale from Not at all interested (scored -1) to Extremely interested (scored 3).
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Post-Intervention Assessment
|
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Recommend the App to a Friend
Time Frame: Post-Intervention Assessment
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Participants responded on a scale from Extremely unlikely (scored -3) to Extremely likely (scored 3).
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Post-Intervention Assessment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
General Child Development Score
Time Frame: 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.
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Change from baseline to post-intervention
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Child Behavior: EMA Challenging Child Behaviors
Time Frame: Daily EMA Data (28 days)
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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.
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Daily EMA Data (28 days)
|
|
Child Behavior: EMA Positive Child Behaviors
Time Frame: 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.
|
Daily EMA Data (28 days)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Bard, PhD, University of Oklahoma
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 13549
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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