Adapting a Parenting Intervention to Promote Healthy Screen Time Habits in Young Children With Behavior Problems
Primary Purpose
Behavior Problem, Parenting
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screen media adapted School Readiness Parenting Program
School Readiness Parenting Program
Sponsored by
About this trial
This is an interventional treatment trial for Behavior Problem focused on measuring child screen media use; behavior; parenting
Eligibility Criteria
Inclusion Criteria:
- eligible child who is 54 to 66 months old at Spring intake (i.e. will be entering Kindergarten after the summer)
- parent-reported externalizing behavior problems on the Kiddie-Disruptive Behavior Disorder Schedule (parent report) or the Disruptive Behavior Disorder Rating Scale (teacher report) that meet criteria for a disruptive behavior disorder diagnosis
- child general cognitive ability score 70 or above on the Differential Abilities Scales-II, - caregiver willing and able to attend weekly parent groups conducted in English.
Exclusion Criteria:
- Families with children with major sensory impairments (e.g., deafness, blindness) or severe problems that impair mobility (e.g., cerebral palsy)are excluded.
Sites / Locations
- Florida International University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Screen media adapted School Readiness Parenting Program
Original School Readiness Parenting Program
Arm Description
Screen media adapted School Readiness Parenting Program (Once weekly session of 1.5 hours for 8 weeks)
Original School Readiness Parenting Program (Once weekly session of 1.5 hours for 8 weeks)
Outcomes
Primary Outcome Measures
Child screen media use (time)
Child screen media use will be measured using a multimethod approach, which combines data collected from screenshots of the app use summary page from the inbuilt Screen Time (iOS) or Digital Wellbeing (Android) tools on mobile devices used by the target child, with parent-reported data on screen use duration (including TV and other screen devices) and content. The outcome variable will be total screen use per week; however any potential differences between screen use on weekends and weekdays will be examined.
Child screen media use (proportion educational)
Ratings of the educational quality of screen media content from the non-profit organization Common Sense Media will be used to designate screen content accessed by children (according to passive sensing data and parent report) as educational or noneducational. The proportion of screen media use that is educational each week will be calculated as time spent on educational screen media divided by overall screen time.
Treatment Attitude Inventory (TAI)
The TAI is a parent-report measure that assesses parent satisfaction with treatment. Test-retest reliability over 4 months and correlations between the TAI and both parent-rating scales and observational measures of treatment change have been demonstrated. The TAI total score will be administered to assess parent satisfaction with the intervention.
Perceived Parental Efficacy Scale
Parents' perceived efficacy in managing children's screen time will be assessed using the Perceived Parental Efficacy subscale of the Parent Perceptions of Technology Scale (PPTS), which assesses parents' self-efficacy in using electronic media and managing children's screen time (e.g., "I won't bother setting parental controls or passwords because my kids will "hack" around them."). The 5 items are rated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Items will be summed to create the overall subscale score.
Technology-related Parenting Scale
The Technology-related Parenting Scale is an 8-item self-report survey assessing parents' use of rules (e.g., "I set limits on the amount of time") and enforcement strategies ("I use passwords on these devices") for children's technology use on a 3-point scale from 0 (not true) to 2 (very true). Items will be summed to create an overall score.
Dyadic Parent-Child Interaction Coding System-Fourth Edition (DPICS-IV)
The Dyadic Parent-Child Interaction Coding System-4th Ed (DPICS-IV; Eyberg et al., 2013) is a structured behavioral observation coding system assessing caregiver-child interactions. Observed parenting behaviors will be coded during a 5-min parent-child play session with a tablet with educational apps and combined into two categories of positive (praises, behavior descriptions, and reflections) and negative (questions, commands, and negative talk) verbalizations, reflecting behaviors caregivers are taught to use and avoid in PCIT. The higher the score the higher quality the parenting behavior.
Secondary Outcome Measures
Full Information
NCT ID
NCT05287685
First Posted
February 22, 2022
Last Updated
August 22, 2023
Sponsor
Florida International University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT05287685
Brief Title
Adapting a Parenting Intervention to Promote Healthy Screen Time Habits in Young Children With Behavior Problems
Official Title
Adapting a Parenting Intervention to Promote Healthy Screen Time Habits in Young Children With Externalizing Behavior Problems
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 28, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida International University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project is a study funded by the National Institute of Child Health and Human Development to develop and pilot test an adapted parenting intervention to decrease excessive/inappropriate screen media use in young children with externalizing behavior problems.
Detailed Description
The goal of this study is to develop and pilot test an adapted screen time intervention for parents of young children with externalizing behavior problems. As young children's access and exposure to different types of screen media devices has increased, so has public health concern around the links between unhealthy early screen media use (including excessive use and exposure to inappropriate content) and poor child outcomes. Research shows that exposure to screen media and externalizing behavior problems in young children are linked. Externalizing behavior problems also present a significant barrier to parents attempting to adhere to screen media use recommendations. Despite these public health concerns, screen media use interventions have not yet specifically targeted children with externalizing behavior problems. To address this need, the investigators propose to explore a novel approach to intervening around screen time, by adapting a behavioral parenting intervention designed for parents of children with externalizing behavior problems to integrate content around screen time. Leveraging an existing evidence-based parenting intervention will allow for the intervention to target parenting generally, as well as screen time specific parenting, without requiring additional resources. This study will focus on adapting a group-based parenting intervention, the School Readiness Parenting Program (SRPP). The SRPP is an 8-week parenting intervention based on a group Parent-Child Interaction Therapy model. In total, 55 parents of preschool-aged children with externalizing behavior problems will be recruited. Following a development phase, the investigators will conduct a small open trial (n = 15) to assess the feasibility of the screen time adapted intervention and families' satisfaction and response to treatment. At this phase, the investigators will also pilot a multimodal method of tracking child screen use using objective data from mobile devices and parent-completed media use logs. Upon making modifications based on results of the open trial and feedback from an external advisory panel of experts and community stakeholders, a pilot randomized controlled trial (n = 40) will follow. Parents will be randomly assigned to receive either the screen time adapted SRPP (n = 20) or the original SRPP (n = 20) program. Assessment measures will be completed at prettest, posttest, and at a 1 month follow up. The investigators will examine feasibility and acceptability of the screen time adapted intervention in the randomized controlled trial. The investigators will also examine children's screen use patterns, including overall screen time, proportion of screen time that is educational, and frequency of parent-child co-use of screen media. In an exploratory fashion, the investigators will examine the effect of the intervention on child externalizing behavior problems.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior Problem, Parenting
Keywords
child screen media use; behavior; parenting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Teachers rating behavior and independent coders assessing parent-child interactions will be masked to condition.
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Screen media adapted School Readiness Parenting Program
Arm Type
Experimental
Arm Description
Screen media adapted School Readiness Parenting Program (Once weekly session of 1.5 hours for 8 weeks)
Arm Title
Original School Readiness Parenting Program
Arm Type
Active Comparator
Arm Description
Original School Readiness Parenting Program (Once weekly session of 1.5 hours for 8 weeks)
Intervention Type
Behavioral
Intervention Name(s)
Screen media adapted School Readiness Parenting Program
Intervention Description
For the screen time adapted parenting intervention, screen time intervention components will be infused into the SRPP (described below) to address three primary areas shown in research to play an important role in healthy screen media use: (1) reducing and managing screen time use; (2) maximizing benefits of screen time content; and (3) promoting positive parent-child interactions during co-use of screen media. Psychoeducation and practice of these strategies will be incorporated into sessions of the SRPP in which relevant behavioral concepts are addressed.The screen time adapted parenting intervention will utilize the same format (large group, 8 weekly 1.5 hour sessions) as the SRPP.
Intervention Type
Behavioral
Intervention Name(s)
School Readiness Parenting Program
Intervention Description
The SRPP is an 8-week parenting program for parents of preschool aged children with externalizing behavior problems. The SRPP targets child externalizing behavior problems specifically, as well as to help parents promote children's school readiness skills. The SRPP follows a group Parent-Child Interaction Therapy (PCIT) model and also uses motivational interviewing and modelling problem solving approaches. The SRPP utilizes a large group format (10-15 parents) with weekly sessions lasting 1.5 hours. The SRPP curriculum contains traditional aspects of behavioral management strategies (e.g., improving parenting skills and the parent-child relationship; discipline strategies such as time out). Specific sessions of the SRPP also directly target parental interactions during children's learning activities and setting up homework and household structure and routines. In its original form, SRPP does not address children's screen time.
Primary Outcome Measure Information:
Title
Child screen media use (time)
Description
Child screen media use will be measured using a multimethod approach, which combines data collected from screenshots of the app use summary page from the inbuilt Screen Time (iOS) or Digital Wellbeing (Android) tools on mobile devices used by the target child, with parent-reported data on screen use duration (including TV and other screen devices) and content. The outcome variable will be total screen use per week; however any potential differences between screen use on weekends and weekdays will be examined.
Time Frame
Change from week 0 to weeks 8 and 12
Title
Child screen media use (proportion educational)
Description
Ratings of the educational quality of screen media content from the non-profit organization Common Sense Media will be used to designate screen content accessed by children (according to passive sensing data and parent report) as educational or noneducational. The proportion of screen media use that is educational each week will be calculated as time spent on educational screen media divided by overall screen time.
Time Frame
Change from week 0 to weeks 8 and 12
Title
Treatment Attitude Inventory (TAI)
Description
The TAI is a parent-report measure that assesses parent satisfaction with treatment. Test-retest reliability over 4 months and correlations between the TAI and both parent-rating scales and observational measures of treatment change have been demonstrated. The TAI total score will be administered to assess parent satisfaction with the intervention.
Time Frame
Week 8
Title
Perceived Parental Efficacy Scale
Description
Parents' perceived efficacy in managing children's screen time will be assessed using the Perceived Parental Efficacy subscale of the Parent Perceptions of Technology Scale (PPTS), which assesses parents' self-efficacy in using electronic media and managing children's screen time (e.g., "I won't bother setting parental controls or passwords because my kids will "hack" around them."). The 5 items are rated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Items will be summed to create the overall subscale score.
Time Frame
Change from week 0 to weeks 8 and 12
Title
Technology-related Parenting Scale
Description
The Technology-related Parenting Scale is an 8-item self-report survey assessing parents' use of rules (e.g., "I set limits on the amount of time") and enforcement strategies ("I use passwords on these devices") for children's technology use on a 3-point scale from 0 (not true) to 2 (very true). Items will be summed to create an overall score.
Time Frame
Change from week 0 to weeks 8 and 12
Title
Dyadic Parent-Child Interaction Coding System-Fourth Edition (DPICS-IV)
Description
The Dyadic Parent-Child Interaction Coding System-4th Ed (DPICS-IV; Eyberg et al., 2013) is a structured behavioral observation coding system assessing caregiver-child interactions. Observed parenting behaviors will be coded during a 5-min parent-child play session with a tablet with educational apps and combined into two categories of positive (praises, behavior descriptions, and reflections) and negative (questions, commands, and negative talk) verbalizations, reflecting behaviors caregivers are taught to use and avoid in PCIT. The higher the score the higher quality the parenting behavior.
Time Frame
Change from week 0 to week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
54 Months
Maximum Age & Unit of Time
66 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
eligible child who is 54 to 66 months old at Spring intake (i.e. will be entering Kindergarten after the summer)
parent-reported externalizing behavior problems on the Kiddie-Disruptive Behavior Disorder Schedule (parent report) or the Disruptive Behavior Disorder Rating Scale (teacher report) that meet criteria for a disruptive behavior disorder diagnosis
child general cognitive ability score 70 or above on the Differential Abilities Scales-II, - caregiver willing and able to attend weekly parent groups conducted in English.
Exclusion Criteria:
Families with children with major sensory impairments (e.g., deafness, blindness) or severe problems that impair mobility (e.g., cerebral palsy)are excluded.
Facility Information:
Facility Name
Florida International University
City
Miami
State/Province
Florida
ZIP/Postal Code
33199
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
A controlled access approach, using a robust system to review requests and provide secure access to de-identified data, will be utilized.
IPD Sharing Time Frame
Deidentified data for the entire database will be made available for data sharing after the main findings from the final dataset have been accepted for publication.
IPD Sharing Access Criteria
Users will be provided with the data under a data-sharing agreement which specifies that: (1) data will be used only for research purposes; (2) data will be stored confidentially and securely; and (3) data will be destroyed after analyses are completed. PI Bagner and collaborators will identify where the data will be available and how to access the data in any publications and presentations using these data.
Learn more about this trial
Adapting a Parenting Intervention to Promote Healthy Screen Time Habits in Young Children With Behavior Problems
We'll reach out to this number within 24 hrs