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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05287685
Other study ID # 1R21HD104367-01A1
Secondary ID 1R21HD104367-01A
Status Completed
Phase N/A
First received
Last updated
Start date April 28, 2022
Est. completion date November 28, 2023

Study information

Verified date December 2023
Source Florida International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date November 28, 2023
Est. primary completion date November 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 54 Months to 66 Months
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Screen media adapted School Readiness Parenting Program
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.
School Readiness Parenting Program
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.

Locations

Country Name City State
United States Florida International University Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
Florida International University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from week 0 to weeks 8 and 12
Primary 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. Change from week 0 to weeks 8 and 12
Primary 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. Week 8
Primary 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. Change from week 0 to weeks 8 and 12
Primary 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. Change from week 0 to weeks 8 and 12
Primary 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. Change from week 0 to week 8
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