Child AbuseNCT05479734
Promoting Resilience and Lowering Risk in Early Childhood
A study testing mHealth Intervention in people with Child Abuse and Child Neglect, run by University of Oklahoma at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 99 years
- Conditions the study is for
- Child Abuse, Child Neglect, Parenting
- What is being tested?
- mHealth Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2022to 12 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any new or currently enrolled parent in Oklahoma or Tulsa County in MIECHV-funded home visiting programs.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Science Center- Center on Child Abuse and Neglect
Oklahoma City, Oklahoma, 73104
About this study
Official title: Promoting Resilience and Lowering Risk in Early Childhood: An mHealth Intervention Study
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.
Read the 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
- Being tested
- mHealth Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth InterventionBehavioural
A smartphone app (mHealth app) will deliver daily tailored messages with tips on monitoring and promoting child development and positive parenting tips.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: mHealth Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Post-Intervention Assessment
Recommend the App to a Friend
Participants responded on a scale from Extremely unlikely (scored -3) to Extremely likely (scored 3).
Measured: Post-Intervention Assessment
Secondary outcomes (3)
General Child Development Score
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.
Measured: Change from baseline to post-intervention
Child Behavior: EMA Challenging Child Behaviors
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.
Measured: Daily EMA Data (28 days)
Child Behavior: EMA Positive Child Behaviors
Parents report the number of positive ("good") child behaviors daily. Analyses compared average behavior counts during periods with and without app-delivered parenting tips.
Measured: Daily EMA Data (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start7 Nov 2022
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Child AbuseStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Bard, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479734
- Sponsor's protocol ID
- 13549
- Status last verified
- Sep 2025
- First submitted
- 8 Jul 2022
- Last updated
- 14 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Resilience and Lowering Risk in Early Childhood: An mHealth Intervention Study
- ClinicalTrials.gov ID
- NCT05479734
- Acronym / sponsor ID
- 13549
- Conditions
- Child Abuse, Child Neglect, Parenting, Child Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Posted 14 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| No parenting tip, then parenting tips | Experimental | Behavioral: mHealth InterventionIn 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. |
| Parenting tips, then no parenting tips | Experimental | Behavioral: mHealth InterventionIn 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. |
Who may qualify
- Ages
- 0 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any new or currently enrolled parent in Oklahoma or Tulsa County in MIECHV-funded home visiting programs.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth InterventionA smartphone app (mHealth app) will deliver daily tailored messages with tips on monitoring and promoting child development and positive parenting tips. | Behavioural | No parenting tip, then parenting tips, Parenting tips, then no parenting tips |
Primary outcome
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.
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).
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.
Helped me Interact Positively With Child
Time frame: 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
Time frame: Post-Intervention Assessment
Participants responded on a scale from Not at all interested (scored -1) to Extremely interested (scored 3).
Recommend the App to a Friend
Time frame: Post-Intervention Assessment
Participants responded on a scale from Extremely unlikely (scored -3) to Extremely likely (scored 3).
3 secondary outcomes
General Child Development Score
Time frame: Change from baseline to post-intervention
Child Behavior: EMA Challenging Child Behaviors
Time frame: Daily EMA Data (28 days)
Child Behavior: EMA Positive Child Behaviors
Time frame: Daily EMA Data (28 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Bard, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Intervention in people with Child Abuse and Child Neglect, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Parenting Practices: EMA Data Positive Parenting Activity Engagement (time frame: Daily EMA Data (28 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.