Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2026-01-01 @ 11:26 AM
Study NCT ID:
NCT07153250
Status:
RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Parent Education for Child Anxiety
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Evaluating the Effects of Self-Guided Interventions for Parents of Young Children With Anxiety
Status:
RECRUITING
Status Verified Date:
2025-08
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:
None
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.
Detailed Description:
Anxiety disorders are very common in children, affecting as many as 30% by adolescence. Even 10% of preschool-age children are already affected. These disorders cause distress and can interfere with academic, social, and family functioning. There are very effective treatments for anxiety disorders, but, on average, kids suffer for four years between onset of their anxiety symptoms and proper diagnosis and treatment. Young children often do not receive treatment because pediatricians, parents, and teachers do not realize that treatment can benefit them and because there is a shortage of providers trained to provide mental health care to young children. Given the importance of early intervention, the investigators are interested in whether parents can learn to better manage their child's anxiety by completing a brief, online, and self-guided parent education program.
Parents will be randomized to one of three self-guided education programs: A three-session program with videos and a workbook and two single-session programs with activities. The programs teach parents how to promote brave behaviors in their child (rather than allowing the child to avoid situations that make them nervous). One of the three programs is considered a control condition, but all are education, and parents will not know whether they are in the control condition until after the 4-month evaluation when they will have the chance to be reassigned to one of the other conditions. The investigators predict that parents who receive one of the active programs, compared to the control, will report greater reductions in parental accommodation across 1-, 4-, and 8-month follow-up. As a secondary hypothesis, the investigators predict that children of parents who receive an active program will show improvements in anxiety symptoms across the 8 month study period.
Because the intervention strategies proposed are brief and easy-to-use, they could be easily implemented as part of routine practice, in much the same way as early intervention for other common childhood health conditions.
Parents will be randomized to one of three self-guided education programs: A three-session program with videos and a workbook and two single-session programs with activities. The programs teach parents how to promote brave behaviors in their child (rather than allowing the child to avoid situations that make them nervous). One of the three programs is considered a control condition, but all are education, and parents will not know whether they are in the control condition until after the 4-month evaluation when they will have the chance to be reassigned to one of the other conditions. The investigators predict that parents who receive one of the active programs, compared to the control, will report greater reductions in parental accommodation across 1-, 4-, and 8-month follow-up. As a secondary hypothesis, the investigators predict that children of parents who receive an active program will show improvements in anxiety symptoms across the 8 month study period.
Because the intervention strategies proposed are brief and easy-to-use, they could be easily implemented as part of routine practice, in much the same way as early intervention for other common childhood health conditions.
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?: