Neurally Targeted Interventions to Reduce Early Childhood Anxiety

NCT03093376 | Completed

• 1 other identifier: HUM00117593
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Keywords

Anxiety; Effortful Control; Preschool; ERN

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Error Related Negativity (ERN) at Post-Intervention

  Error-related negativity (ERN) is assessed through the "Zoo task", a "Go/No-Go" paradigm assessing effortful control. Children view a series of animals on a computer screen and are asked to press a button when a new animal appears (Go trials), unless the animal is an orangutan (i.e., inhibit button response, No-Go trials). The task includes 8 blocks, each containing 30 unique animals (Go trials) and 10 orangutans (No-Go trials) in random order. Event related potentials (ERP; direct responses to stimuli measured using electroencephalography) will be examined from fronto-central recording sites time-locked to error and correct response. Differentiation between these trial types is the primary ERN measure, but ERN in error trials will also be considered, as well as ERPs in correct trials. The number of No-Go errors and response times (RTs) to Go trials will also be considered in analyses, as performance can affect ERN amplitude.

  approximately 10 weeks

• Change from Baseline Fear Potentiated Startle (FPS) at Post-Intervention

  Preschool participants watch age appropriate film clips (four fearful, four neutral, and four happy clips). White noise bursts are presented at varying time points to elicit the startle eyeblink response (FPS), recorded from two electrodes under the left eye.

  approximately 10 weeks

Secondary Outcomes (1)

• Change in Anxiety Symptoms

  approximately 10 weeks

Study Arms (1)

Effortful Control Camp

EXPERIMENTAL

Children will participate in an interactive, child-friendly "camp" comprised of short, game-like exercises to teach inhibitory and attentional control, as well as visuospatial and working memory skills.

Behavioral: Effortful Control Camp

Interventions

Effortful Control Camp BEHAVIORAL

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.

Also known as: EC Camp

Effortful Control Camp

Eligibility Criteria

• Age: 48 Months - 83 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between 4.0 and 6.99 years
• Child has current anxiety symptoms
• Parent/caregiver is English-speaking.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Michigan State University: collaborator
• One Mind Institute: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 35708131 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Child participants receive effortful control (EC) training.

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: March 28, 2017
• Study Start: March 30, 2017
• Primary Completion: March 6, 2020
• Study Completion: October 29, 2020
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)