Neurally Targeted Interventions to Reduce Early Childhood Anxiety



Status:Recruiting
Conditions:Anxiety
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:7/22/2018
Start Date:March 30, 2017
End Date:December 2019
Contact:Jessica Hruschak, BA
Email:jlhrus@med.umich.edu
Phone:734-232-0205

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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.

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 4 mornings (Saturday and Sunday over two
consecutive weekends) from 9AM to 12PM. These times were 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). Of the 40 participants enrolled in the study, 20 will be
randomized to receive the EC training intervention and 20 to wait list control. 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.

Inclusion Criteria:

- Children between 4.0 and 6.99 years

- Child has current anxiety symptoms

- Parent/caregiver is English-speaking.

Exclusion Criteria:

- Child cannot be currently taking medications that affect central nervous system
functioning.

- No history of:

- Head injury

- Serious medical or neurological illness

- Post-Traumatic Stress Disorder

- Neurodevelopmental delay

- Autism spectrum disorder (ASD)

- Intellectual disability
We found this trial at
1
site
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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