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Neurally Targeted Interventions to Reduce Early Childhood Anxiety

NCT03093376 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-08-12

No results posted yet for this study

Summary

Clinically significant anxiety affects up to 20% of preschool-aged children and often fails to respond to currently available treatments. Emerging science suggests that increasing brain capacity for "effortful control" (EC) may help anxious children to regulate emotion and behavior to improve outcomes. Thus, in the proposed study, children will be trained on EC tasks (including selective attention, response inhibition, etc.) to increase capacity for effortful control (EC) over fear behaviors. To determine whether EC training improves brain capacity to regulate fear, investigators will assess neurophysiological and behavioral indices of effortful control and fear reactivity before and after this training.

Conditions

  • Anxiety Disorders

Interventions

BEHAVIORAL

Effortful Control Camp

An interactive, child-friendly "camp". Effortful control (EC) camp is comprised of short, game-like exercises taught by "camp counselors" to groups of approximately 4-6 children. In total, 12 different exercises that teach inhibitory and attentional control, as well as visuospatial and working memory skills, will be administered. Tasks will allow for "scaffolding" (Halperin et al, 2013), or incremental increases in difficulty of the games over time. EC camp will occur over 4 mornings from 9AM to 12PM, on two consecutive weekends.

Sponsors & Collaborators

Principal Investigators

  • Kate D Fitzgerald, MD · University of Michigan

  • Maria Muzik, MD · University of Michigan

  • Kate Rosenblum, PhD · University of Michigan

  • Jason Moser, PhD · Michigan State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
48 Months
Max Age
83 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-30
Primary Completion
2020-03-06
Completion
2020-10-29

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03093376 on ClinicalTrials.gov