Screen Media UseBEENCT07394166
Balancing Emotions and Electronics: A Pilot Intervention for Preschoolers
A study testing Brief-RSU in people with Screen Media Use, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 54 monthsHealthy volunteers can take part
- Conditions the study is for
- Screen Media Use
- What is being tested?
- Brief-RSU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 26 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 54 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Caregiver endorses regulatory screen use
- Child age 30-54 months at enrollment
- English speaking
Who cannot join
- Intellectual disability or global developmental delay
- Autism spectrum disorder
- Child in the custody of DCF
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Tech-Parenting for Regulatory Screen Use in Young Children: A Pilot Study
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).
Read the 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.
- Conditions
- Screen Media Use
- Being tested
- Brief-RSU
- Keywords
- childhood, screen time, parenting, intervention, self-regulation, preschool
- Medical subject headings
- Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief-RSUBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 3-session, virtual group therapy Receives: Behavioral: Brief-RSU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regulatory Screen Use (RSU)
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).
Measured: Baseline; 1-month follow up (i.e., 1 month after the last workshop).
Secondary outcomes (3)
Child self-regulation (BRIEF-Preschool)
Caregiver report on an age- and gender-normed questionnaire assessing child emotional and behavioral regulation.
Measured: Baseline; 1-month follow up (i.e., 1 month after the last workshop).
Parental Stress Scale
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.
Measured: Baseline; 1-month follow up (i.e., 1 month after the last workshop).
Perceived Stress Scale
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.
Measured: Baseline; 1-month follow up (i.e., 1 month after the last workshop).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Mar 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion26 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Screen Media UseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginia Peisch, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394166
- Sponsor's protocol ID
- P00052998
- Acronym
- BEE
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Limited IPD will be shared upon reasonable request from the researcher.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Tech-Parenting for Regulatory Screen Use in Young Children: A Pilot Study
- ClinicalTrials.gov ID
- NCT07394166
- Acronym / sponsor ID
- BEE / P00052998
- Conditions
- Screen Media Use
- Keywords
- childhood, screen time, parenting, intervention, self-regulation, preschool
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 26 Oct 2026 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Brief-RSU3-session, virtual group therapy |
Who may qualify
- Ages
- 30 to 54 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Caregiver endorses regulatory screen use
- Child age 30-54 months at enrollment
- English speaking
Key exclusion criteria (3 listed)
- Intellectual disability or global developmental delay
- Autism spectrum disorder
- Child in the custody of DCF
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 |
|---|---|---|
| Brief-RSUBrief-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). | Behavioural | Intervention |
Primary outcome
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).
3 secondary outcomes
Child self-regulation (BRIEF-Preschool)
Time frame: Baseline; 1-month follow up (i.e., 1 month after the last workshop).
Parental Stress Scale
Time frame: Baseline; 1-month follow up (i.e., 1 month after the last workshop).
Perceived Stress Scale
Time frame: Baseline; 1-month follow up (i.e., 1 month after the last workshop).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided. Limited IPD will be shared upon reasonable request from the researcher.
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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 Brief-RSU in people with Screen Media Use, run by Boston Children's Hospital 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 3 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Regulatory Screen Use (RSU) (time frame: Baseline; 1-month follow up (i.e., 1 month after the last workshop).). 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 10 Sep 2026.