NCT07153250

Brief Summary

The investigators are doing this research to test whether parents of children ages 2-7 can better manage their child's anxiety by completing a brief, online, self-guided parent education program. One way to provide anxiety management skills to more children, and to potentially prevent worsening outcomes, is to offer online and self-guided educational programs that parents can complete without a clinician. This randomized trial will evaluate the effects of two brief, online, self-guided parent education programs designed to improve parents' understanding of anxiety and teach parents way to help their children cope with anxiety. Parents will be randomly assigned to one of the three programs. The main aim of the study is to examine whether the parent programs, compared to an educational control reduce parental accommodation of anxiety across a 1-, 4-, and 8-month follow-up period. As a secondary aim, the investigators will explore whether the parent programs reduce children's anxiety symptoms over the 8-month follow-up period. Results will inform the development of a scalable, low-cost model for promoting access to evidence-based treatment to young children.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Sep 2025

Typical duration 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 Progress38%
Sep 2025Aug 2027

First Submitted

Initial submission to the registry

August 24, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

September 29, 2025

Status Verified

August 1, 2025

Enrollment Period

1.9 years

First QC Date

August 24, 2025

Last Update Submit

September 24, 2025

Conditions

Keywords

AnxietyParentingOnline InterventionChild Mental Health

Outcome Measures

Primary Outcomes (1)

  • Change in Pediatric Accommodation Scale, Parent-Report

    The Pediatric Accommodation Scale is a parent-report of accommodation of their offspring's anxiety. Parents are asked to rate, on a 5-point scale from 0 (never) to 5 (always), the extent to which they accommodate their child's anxiety or avoidance behaviors. Total scores range from 0 to 25, with higher scores reflecting greater parental accommodation. Parents will report on their accommodation behaviors at baseline , 1-, 4-, and 8-months.

    Change over 8-month follow-up (Baseline to 1-month, 4-month, and 8-month follow-up)

Secondary Outcomes (1)

  • Change in Child Anxiety Symptoms, Parent-Report Total T-Score

    Change over 8-month follow-up (Baseline to 1-month, 4-month, and 8-month follow-up)

Study Arms (3)

Project Empower

EXPERIMENTAL

This program is a web-based, self-administered program for parents that takes about 20 minutes to complete. The program includes 5 elements based on the components of cognitive-behavioral therapy.

Behavioral: Project EMPOWER

Being Brave

EXPERIMENTAL

This program is an online, self-guided program which consists of three brief video-recorded lessons (approximately 20 minutes each) with accompanying knowledge checks and workbook on implementing parent-directed cognitive-behavioral therapy.

Behavioral: Being Brave Parent Education

Sharing Feelings

SHAM COMPARATOR

This program is an online, self-guided 20-minute program, that teaches parents about the importance of sharing feelings and about helpful versus unhelpful expression of emotion.

Behavioral: Sharing Feelings

Interventions

Project EMPOWERBEHAVIORAL

Project EMPOWER is a web-based, self-administered program for parents that takes about 20 minutes to complete.

Project Empower

Being Brave Parent Education is an online, self-guided program which consists of three brief video-recorded lessons (approximately 20 minutes each) with accompanying knowledge checks and workbook on implementing parent-directed cognitive-behavioral therapy.

Being Brave

A self-guided 20-minute educational control, that teaches parents about the importance of sharing feelings and about helpful versus unhelpful expression of emotion.

Sharing Feelings

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents will be eligible to participate if:
  • Their child is between the age of 2 and 7 years-old
  • Their child scores in the elevated range on an age-approrpiate anxiety screening measure
  • Parents are English-speaking
  • Parents are over the age of 18 years old

You may not qualify if:

  • Parents will be excluded if:
  • (1) Their child shows symptoms of suicidal or homicidal ideation, psychosis, or primary severe mood or behavior disorder (i.e., if treatment for another disorder other than anxiety is indicate prior to treatment for anxiety)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Eligible participants will be randomized (1:1:1 allocation ratio) to receive a three-session program with videos and a workbook or one of two single-session programs with activities. One of the three programs is considered a control condition, but all are education. All parents will repeat baseline evaluation measures 1- and 4-months post baseline. Those in the active groups will also repeat measures at 8-months. Those initially randomized to the control program can be re-randomized after 4 months to either of the active program and will complete subsequent 1- and 4-month follow-up measures post re-randomization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychology

Study Record Dates

First Submitted

August 24, 2025

First Posted

September 3, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

September 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations