Neurally Targeted Interventions to Reduce Early Childhood Anxiety
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

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.
    

Intervention name(s): Effortful Control Camp
Intervention type(s): Behavioral
Intervention description(s): 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.
Other intervention name(s): EC Camp
Intervention model: Single Group Assignment
Intervention model description: Child participants receive effortful control (EC) training.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anxiety; Effortful Control; Preschool; ERN