- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07394166
Balancing Emotions and Electronics: A Pilot Intervention for Preschoolers (BEE)
Brief Tech-Parenting for Regulatory Screen Use in Young Children: A Pilot Study
Study Overview
Detailed Description
Project Aims / Hypotheses. This intervention study aims to refine and test a brief, caregiver delivered therapeutic program targeting the problematic use of screen time to regulate young children's emotions and boredom, i.e. "regulatory screen use" (RSU). RSU is a candidate mechanism for the negative impacts of screen time on children's mental health; therefore, this proposal addresses the growing public health concern related to pervasive digital media use. Our group has already developed an effective brief tech-parenting program for school-age children; the current study will expand this intervention to target RSU in young children.
Aim 1: Develop and test the acceptability and feasibility of a brief tech-parenting intervention targeting RSU (Brief-RSU) with caregivers of 30 children ages 30-54 months. Hypothesis 1: We expect that Brief-RSU will be highly acceptable and feasible, as evidenced by high retention rates and positive caregiver feedback.
Aim 2: Determine the efficacy of Brief-RSU on caregiver and child outcomes. We expect that Brief-RSU will increase adaptive caregiving (e.g., emotion coaching; reduction in RSU) from pre to post (Hypothesis 2a) and significantly improve child emotion and behavior regulation (Hypothesis 2b).
Background. Significant concern among scientists and the public has emerged over the last decade regarding the adverse effects of screen media activity on child development, including poor sleep, reduced educational achievement, greater behavior problems, inattention, and anxiety. Despite this widespread concern, clinical recommendations on child digital media management are currently lacking, primarily due to gaps in our knowledge base. Existing research predominantly relies on simplistic screen media measures, such as total screen time, that do not consider the context and function of screen media use. Altogether, there is an urgent need to expand what is known about the mechanisms by which digital media negatively impact child development in order to provide effective and evidence-based recommendations to caregivers, clinicians, and policymakers.
Regulatory screen use (RSU), which describes the use of screen media to calm or occupy children at home and in public, has already been shown to be highly prevalent and associate with poor child outcomes. For example, a longitudinal study of more than 400 preschoolers found that higher RSU at baseline predicted worse executive functioning in girls and more emotional reactivity in boys 6 months later. Further, a study of 200 preschool-age children found concurrent associations between RSU, empathy, and emotional control. We propose that RSU affects psychosocial development by depriving children of critical opportunities to practice self-regulation skills. The proposed study will be the first to test whether a brief, caregiver-focused intervention can reduce RSU, while also strengthening adaptive parenting and child emotional well-being.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Virginia Peisch, PhD
- Phone Number: 617-355-0725
- Email: virginia.peisch@childrens.harvard.edu
Study Contact Backup
- Name: Anne B Arnett, PhD
- Email: ArnettLab@childrens.harvard.edu
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Recruiting
- Developmental Medicine
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Contact:
- Virginia Peisch, phd
- Phone Number: 617-355-6000
- Email: virginia.peisch@childrens.harvard.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Caregiver endorses regulatory screen use
- Child age 30-54 months at enrollment
- English speaking
Exclusion Criteria:
- Intellectual disability or global developmental delay
- Autism spectrum disorder
- Child in the custody of DCF
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
3-session, virtual group therapy
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Brief-RSU Intervention: The Brief-RSU intervention consists of three, 60-minute sessions, outlined in Table 1.
Brief-RSU aims to reduce RSU while increasing adaptive caregiver tools.
Treatment targets include: 1) psychoeducation, 2) scheduling screen time to consistent times, 3) "planning ahead" for times when RSU is likely to occur, and 4) teaching the RULER approach[9, 10] to strengthen caregiver socialization of child emotion regulation (replacement behavior).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Regulatory Screen Use (RSU)
Time Frame: Baseline; 1-month follow up (i.e., 1 month after the last workshop).
|
Caregiver reported frequency of using screen time and non-screen time strategies to regulate a child's emotions.
For example, the caregiver is asked how frequently they use screens (e.g., iPad; smartphone) to help keep their child calm when they are expected to sit still (e.g., at a restaurant).
Seven different situations/settings are assessed (e.g., sibling conflict; at church or doctor's office).
|
Baseline; 1-month follow up (i.e., 1 month after the last workshop).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child self-regulation (BRIEF-Preschool)
Time Frame: Baseline; 1-month follow up (i.e., 1 month after the last workshop).
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Caregiver report on an age- and gender-normed questionnaire assessing child emotional and behavioral regulation.
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Baseline; 1-month follow up (i.e., 1 month after the last workshop).
|
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Parental Stress Scale
Time Frame: Baseline; 1-month follow up (i.e., 1 month after the last workshop).
|
Caregiver self-report of confidence and stress related to parenting.
The caregiver is asked to select one option (1=strongly disagree; 5=strongly agree) on questions related to their experience parenting.
There is a total of 18 questions.
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Baseline; 1-month follow up (i.e., 1 month after the last workshop).
|
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Perceived Stress Scale
Time Frame: Baseline; 1-month follow up (i.e., 1 month after the last workshop).
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Caregiver self-report of general stress and well-being.
The caregiver is asked to select one response option (0=never; 4=very often) that best describes their current level of perceived stress.
There is a total of 10 questions.
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Baseline; 1-month follow up (i.e., 1 month after the last workshop).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of Workshop
Time Frame: Immediately following the 3-session workshop.
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After completion of the three workshops on RSU, participant will be asked to provide feedback on how helpful the workshop curriculum was and how much they learned (managing child screen time; regulating their child's emotions).
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Immediately following the 3-session workshop.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P00052998
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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