Behavior ProblemNCT05287685
Adapting a Parenting Intervention to Promote Healthy Screen Time Habits in Young Children With Behavior Problems
A study testing Screen media adapted School Readiness Parenting Program and School Readiness Parenting Program in people with Behavior Problem and Parenting, run by Florida International University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 54 to 66 monthsHealthy volunteers can take part
- Conditions the study is for
- Behavior Problem, Parenting
- What is being tested?
- Screen media adapted School Readiness Parenting Program and School Readiness Parenting Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2022to 28 Nov 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 54 to 66 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Families with children with major sensory impairments (e.g., deafness, blindness) or severe problems that impair mobility (e.g., cerebral palsy)are excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
Official title: Adapting a Parenting Intervention to Promote Healthy Screen Time Habits in Young Children With Externalizing Behavior Problems
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.
Read the 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.
- Conditions
- Behavior Problem, Parenting
- Being tested
- Screen media adapted School Readiness Parenting Program, School Readiness Parenting Program
- Keywords
- child screen media use; behavior; parenting
- Medical subject headings
- Mental Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screen media adapted School Readiness Parenting ProgramBehavioural
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Screen media adapted School Readiness Parenting Program | Experimental | Screen media adapted School Readiness Parenting Program (Once weekly session of 1.5 hours for 8 weeks) Receives: Behavioral: Screen media adapted School Readiness Parenting Program |
| Original School Readiness Parenting Program | Active comparator | Original School Readiness Parenting Program (Once weekly session of 1.5 hours for 8 weeks) Receives: Behavioral: School Readiness Parenting Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Screen Media Use (Time)
Child screen media use will be measured 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 weekend day.
Measured: Change from baseline (week 0) to posttest (week 8) and follow-up (week 16)
Child Screen Media Use (Proportion Educational)
The proportion of child screen media use that parents report is educational.
Measured: Change from baseline (week 0) to posttest (week 8) and follow-up (week 16)
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. The minimum value is 0 and the maximum is 50, with higher scores indicating better satisfaction.
Measured: Posttest (Week 8)
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 were reverse scored and averaged to create the overall scale score, with higher scores meaning better perceived efficacy.
Measured: Change from baseline (week 0) to posttest (week 8) and follow-up (week 16).
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 averaged to create an overall score, with higher scores meaning more limit setting.
Measured: Change from baseline (week 0) to posttest (week 8) and follow-up (week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start28 Apr 2022
- Primary completion28 Nov 2023
- Study completion28 Nov 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 Behavior ProblemStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287685
- Sponsor's protocol ID
- 1R21HD104367-01A1
- Other IDs
- 1R21HD104367-01A1
- Status last verified
- Nov 2024
- First submitted
- 22 Feb 2022
- Last updated
- 15 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A controlled access approach, using a robust system to review requests and provide secure access to de-identified data, will be utilized.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting a Parenting Intervention to Promote Healthy Screen Time Habits in Young Children With Externalizing Behavior Problems
- ClinicalTrials.gov ID
- NCT05287685
- Acronym / sponsor ID
- 1R21HD104367-01A1
- Conditions
- Behavior Problem, Parenting
- Keywords
- child screen media use; behavior; parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Posted 15 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screen media adapted School Readiness Parenting Program | Experimental | Behavioral: Screen media adapted School Readiness Parenting ProgramScreen media adapted School Readiness Parenting Program (Once weekly session of 1.5 hours for 8 weeks) |
| Original School Readiness Parenting Program | Active comparator | Behavioral: School Readiness Parenting ProgramOriginal School Readiness Parenting Program (Once weekly session of 1.5 hours for 8 weeks) |
Who may qualify
- Ages
- 54 to 66 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Families with children with major sensory impairments (e.g., deafness, blindness) or severe problems that impair mobility (e.g., cerebral palsy)are excluded.
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 |
|---|---|---|
| Screen media adapted School Readiness Parenting ProgramFor 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. | Behavioural | Screen media adapted School Readiness Parenting Program |
| School Readiness Parenting ProgramThe 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. | Behavioural | Original School Readiness Parenting Program |
Primary outcome
Child Screen Media Use (Time)
Time frame: Change from baseline (week 0) to posttest (week 8) and follow-up (week 16)
Child screen media use will be measured 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 weekend day.
Child Screen Media Use (Proportion Educational)
Time frame: Change from baseline (week 0) to posttest (week 8) and follow-up (week 16)
The proportion of child screen media use that parents report is educational.
Treatment Attitude Inventory (TAI)
Time frame: Posttest (Week 8)
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. The minimum value is 0 and the maximum is 50, with higher scores indicating better satisfaction.
Perceived Parental Efficacy Scale
Time frame: Change from baseline (week 0) to posttest (week 8) and follow-up (week 16).
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 were reverse scored and averaged to create the overall scale score, with higher scores meaning better perceived efficacy.
Technology-related Parenting Scale
Time frame: Change from baseline (week 0) to posttest (week 8) and follow-up (week 16)
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 averaged to create an overall score, with higher scores meaning more limit setting.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. A controlled access approach, using a robust system to review requests and provide secure access to de-identified data, will be utilized.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screen media adapted School Readiness Parenting Program and School Readiness Parenting Program in people with Behavior Problem and Parenting, run by Florida International University 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 3 inclusion and 1 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 15 Nov 2024. 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 15 Nov 2024). 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?
Child Screen Media Use (Time) (time frame: Change from baseline (week 0) to posttest (week 8) and follow-up (week 16)). The study lists 5 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 15 Nov 2024.