Clinical trial NCT03093376: Neurally Targeted Interventions to Reduce Early Childhood Anxiety
Official title: Neurally Targeted Interventions to Reduce Early Childhood Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Keywords: Anxiety
Effortful Control
Preschool
ERN
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Michigan State University
name: One Mind Institute
First posted: 2017-03-28
Enrollment: 48
Sex: ALL
Minimum age (years): 48
Maximum age (years): 83
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Child participants receive effortful control (EC) training.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 8.4.21 Update: In late 2020, funding for a larger version of this study was received. Although originally intended to include randomization between active EC training and a waitlist control, this original pilot study was only able to collect data for the active EC training condition. The larger study (NCT04960813) recruits children to participate in a protocol with both the original EC training and an active play-based comparison group.

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 examined child participants with clinical to subclinical anxiety 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 were sought to complete a camp-like EC training (up to n=40). Before and after the intervention (time 1 and time 2, respectively), an EEG-based measure, the error-related negativity (ERN), was collected while children play a simple computer game. The ERN indexes neural mechanisms underlying EC. Other measures collected before and after the EC training included a blink reflex known as the fear potentiated startle (FPS); laboratory-assessed EC and fear behaviors; and, clinically assessed anxiety symptoms. Originally, the study was designed to include randomization between the EC training and a waitlist control; however, due to limited personnel and financial constraints, a decision was made to focus enrollment on the EC training.

The EC intervention or "EC camp" occurred over several sessions spread across 2 or more weeks. Times were chosen to maximize child focus and energy as well as convenience for families. EC camp was comprised of short, game-like exercises that teach effortful control skills (e.g., response inhibition, selective attention, set shifting skills).

As originally planned, primary analyses tested for group mean differences in ERN and FPS changes (i.e. from time 1 to time 2) among children assigned to EC training. Secondary analyses tested relationship of changes in neurophysiological targets with change in EC and Fear behaviors and change in anxiety severity.

This study was designed to examine the mechanistic plausibility of a precise, neuroscientifically-derived treatment for childhood anxiety, promoting developmental trajectories towards health and away from chronic illness.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Error Related Negativity (ERN) at Post-Intervention
timeFrame: approximately 10 weeks
measure: Change from Baseline Fear Potentiated Startle (FPS) at Post-Intervention
timeFrame: approximately 10 weeks
Secondary outcomes:
measure: Change in Anxiety Symptoms
timeFrame: approximately 10 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Kate D Fitzgerald, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Maria Muzik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Kate Rosenblum, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan State University
name: Jason Moser, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schroder HS, Ip KI, Hruschak JL, Horbatch F, Hall M, Liu Y, Mannella K, Muzik M, Rosenblum KL, Moser JS, Fitzgerald KD. Targeting cognitive control to reduce anxiety in very young children: A proof of concept study. Depress Anxiety. 2022 Aug;39(8-9):646-656. doi: 10.1002/da.23270. Epub 2022 Jun 16.