Neurally Targeted Interventions to Reduce Early Childhood Anxiety
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anxiety Disorders
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Child participants may be randomized to effortful control (EC) training or wait list. If wait list is assigned, children will receive EC training materials after completing pre- and post-wait list assessments.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 4883 years
- Gender
- Both males and females
Description
4.3.20 Update: Recruitment is ongoing. Enrollment and interactions are temporarily paused due to COVID-19. This is not a suspension of IRB approval. This experiment will randomize child participants with clinical to subclinical anxiety across two conditions to test the effects of a piloted effortful...
4.3.20 Update: Recruitment is ongoing. Enrollment and interactions are temporarily paused due to COVID-19. This is not a suspension of IRB approval. This experiment will randomize child participants with clinical to subclinical anxiety across two conditions to test the effects of a piloted effortful control (EC) training intervention. Up to 40 preschool age children (4-6.99 years) with clinical to subclinical anxiety symptoms will complete either a camp-like EC training (n=20) or a waitlist control (n=20). Before and after the active and control conditions (time 1 and time 2, respectively), an EEG-based measure, the error-related negativity (ERN), will be collected while children play a simple computer game. The ERN indexes neural mechanisms underlying EC. Other measures to be collected before and after the EC training include a blink reflex known as the fear potentiated startle (FPS); laboratory-assessed EC and fear behaviors; and, clinically assessed anxiety symptoms. The EC intervention or "EC camp" will occur over several sessions spread across 2 or more weeks. Times are chosen to maximize child focus and energy as well as convenience for families. EC camp is comprised of short, game-like exercises that teach effortful control skills (e.g., response inhibition, selective attention, set shifting skills). Wait list participants will be given a set of written materials (adapted from the EC camp protocol) to complete at home with their caregivers after the post-wait list assessment. Primary analyses will test for group mean differences in ERN and FPS changes (i.e. from time 1 to time 2) among children assigned to EC training compared to those in the control condition. Secondary analyses will test relationship of changes in neurophysiological targets with change in EC and Fear behaviors and change in anxiety severity. This study hopes to examine the mechanistic plausibility of a precise, neuroscientifically-derived treatment for childhood anxiety, promoting developmental trajectories towards health and away from chronic illness.
Tracking Information
- NCT #
- NCT03093376
- Collaborators
- Michigan State University
- One Mind Institute
- Investigators
- Principal Investigator: Kate D Fitzgerald, MD University of Michigan Principal Investigator: Maria Muzik, MD University of Michigan Principal Investigator: Kate Rosenblum, PhD University of Michigan Principal Investigator: Jason Moser, PhD Michigan State University