Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:01 AM
Study NCT ID:
NCT07394166
Status:
RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balancing Emotions and Electronics: A Pilot Intervention for Preschoolers
Sponsor:
Boston Children's Hospital
Organization:
Study Overview
Official Title:
Brief Tech-Parenting for Regulatory Screen Use in Young Children: A Pilot Study
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEE
Brief Summary:
This study is testing a brief, virtual therapy for caregivers of preschool children. The goal is to reduce use of screen time to regulate young children's emotions and boredom, i.e. "regulatory screen use" (RSU). We expect that RSU negatively impacts young children's ability to cope with emotions and boredom. Thus, reducing RSU should improve children's self-regulation. The intervention will include three, 60-minute group sessions with caregivers, and remote data collection at three time points (pre-intervention, post-intervention, and 1-month follow-up).
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: