Promoting Resilience and Lowering Risk in Early Childhood

Child Development Clinical Trial

Official title:

Promoting Resilience and Lowering Risk in Early Childhood: An mHealth Intervention Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05479734
• Other study ID #: 13549
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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 with the mHealth app and individual characteristics of parents and families (e.g., age of child, level of adversity exposure) will predict app utilization outcomes. 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 on days when they do not receive this content. 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 greater emotional and behavioral functioning on days when their parents report more positive parenting practices. Hypothesis 2b. Children of parents who report greater daily engagement in positive parenting practices will achieve higher levels of development at the follow-up assessment relative to children of parents who report lower daily levels of positive parenting practices.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: June 30, 2024
• Est. primary completion date: June 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Abuse
• Child Development
• Child Neglect
• Parenting

Intervention

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

Locations

Country	Name	City	State
United States	University of Oklahoma Health Science Center- Center on Child Abuse and Neglect	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive Parenting Practices: EMA Data Positive Parenting Practices	Participants select the positive parenting practices 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 higher number represent more activities reported)	Daily EMA Data (28 days)
Primary	Positive Parenting Practices: Positive Parenting Practices Questionnaire	Self-report questionnaire in which caregivers select how many days a week they engage in 15 different positive parenting practices with their child. ( Items are rated on a Likert scale 0 (never) to 7 (everyday) with 0 being the lowest score and 105 being the maximum total score and higher scores represent higher reported engagement in positive parenting practices)	Change from baseline to follow-up (1-3 months post-intervention)
Primary	Parenting Behavior: Alabama Parenting Questionnaire	The Alabama Parenting Questionnaire consists of 5 subscales 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. The subscales are: Poor Monitoring (10 items (score range: 0-50)); Corporal Punishments (3 items (score range: 0-15)); Positive Parenting (6 items (score range: 0-30); Involvement (10 items (scoring range: 0-50)); Inconsistent Discipline (5 items (scoring range: 0-25))	Change from baseline to follow-up (1-3 months post-intervention)
Primary	Parenting Behavior: Parenting Interactions with Children: Checklist of Observations Linked to Outcomes	Checklist of 29 observable developmentally supportive parenting behaviors in four domains (affection, responsiveness, encouragement, and teaching) 0 is the lowest and 29 is the highest, with higher scores representing more behaviors observed.	Change from baseline to follow-up (1-3 months post-intervention)
Primary	Parenting Behavior: EMA Data on Parent Response to Child Positive and Negative Behavior	Parents report how they responded to their child's positive and negative behavior during each day of the EMA study	Daily EMA Data (28 days)
Primary	Parent Satisfaction with App: Ease of Use and Satisfaction Survey	12-item survey that parents complete about the ease of use and their satisfaction with the mHealth App (scores range from 0-58, with a higher score representing higher satisfaction)	Last Day of EMA Data Collection
Secondary	Parenting Stress: Parenting Stress Index- Short Form	36-item measure divided into 3 domains: Parental Distress; Parent-Child Dysfunctional Interaction; and Difficult Child. These are summed together to create the Total Stress scale. Each item is rated on a 1 (strongly agree) to 5 (strongly disagree) scale. The scoring can range from 24-180, with lower scores representing higher parenting stress.	Change from baseline to follow-up (1-3 months post-intervention)
Secondary	Child Development	Ages and Stages- 3	Change from baseline to follow-up (1-3 months post-intervention)
Secondary	Child Development:	Developmental Profiles- 4	Change from baseline to follow-up (1-3 months post-intervention)
Secondary	Child Behavior: EMA Data Positive and Negative Behaviors	Parents report the number of positive and negative behaviors their child engages in and what the behaviors are each day of EMA study.	Daily EMA Data (28 days)
Secondary	Child Adversity Exposure: Parent-Child Conflict Scale	23-item measure parent-report measure that provides information regarding the presence and severity of parenting behaviors associated with child maltreatment. Each item is scored on a 0 (never) to 7 (more than 20 times in past 6 months) Total score can range 0-161 with higher scores representing higher presence of parenting behaviors associated with child maltreatment.	Change from baseline to follow-up (1- 3 months post-intervention)