NCT07394166

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Mar 2026Oct 2026

First Submitted

Initial submission to the registry

January 5, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2026

Expected
Last Updated

March 18, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 5, 2026

Last Update Submit

March 16, 2026

Conditions

Keywords

childhoodscreen timeparentinginterventionself-regulationpreschool

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline; 1-month follow up (i.e., 1 month after the last workshop).

Secondary Outcomes (3)

  • Child self-regulation (BRIEF-Preschool)

    Baseline; 1-month follow up (i.e., 1 month after the last workshop).

  • Parental Stress Scale

    Baseline; 1-month follow up (i.e., 1 month after the last workshop).

  • Perceived Stress Scale

    Baseline; 1-month follow up (i.e., 1 month after the last workshop).

Other Outcomes (1)

  • Acceptability of Workshop

    Immediately following the 3-session workshop.

Study Arms (1)

Intervention

EXPERIMENTAL

3-session, virtual group therapy

Behavioral: Brief-RSU

Interventions

Brief-RSUBEHAVIORAL

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).

Intervention

Eligibility Criteria

Age30 Months - 54 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Caregiver endorses regulatory screen use
  • Child age 30-54 months at enrollment
  • English speaking

You may not qualify if:

  • Intellectual disability or global developmental delay
  • Autism spectrum disorder
  • Child in the custody of DCF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Developmental Medicine

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Self-Control

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor of Pediatrics

Study Record Dates

First Submitted

January 5, 2026

First Posted

February 6, 2026

Study Start

March 1, 2026

Primary Completion

June 30, 2026

Study Completion (Estimated)

October 26, 2026

Last Updated

March 18, 2026

Record last verified: 2026-01

Locations