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Neurally Targeted Interventions to Reduce Early Childhood Anxiety

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Effortful Control Camp
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Anxiety, Effortful Control, Preschool, ERN

Eligibility Criteria

48 Months - 83 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Effortful Control Camp

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in Anxiety Symptoms
Assessed using the Spence Anxiety Scale for Preschoolers (Spence, Rapee, McDonald, & Ingram, 2001). This 34-item parent-report scale provides an overall measure of child anxiety.

Full Information

First Posted
January 30, 2017
Last Updated
August 4, 2021
Sponsor
University of Michigan
Collaborators
Michigan State University, One Mind Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03093376
Brief Title
Neurally Targeted Interventions to Reduce Early Childhood Anxiety
Official Title
Neurally Targeted Interventions to Reduce Early Childhood Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
March 6, 2020 (Actual)
Study Completion Date
October 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Michigan State University, One Mind Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Anxiety, Effortful Control, Preschool, ERN

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Child participants receive effortful control (EC) training.
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Effortful Control Camp
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Effortful Control Camp
Other Intervention Name(s)
EC Camp
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Error Related Negativity (ERN) at Post-Intervention
Description
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.
Time Frame
approximately 10 weeks
Title
Change from Baseline Fear Potentiated Startle (FPS) at Post-Intervention
Description
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.
Time Frame
approximately 10 weeks
Secondary Outcome Measure Information:
Title
Change in Anxiety Symptoms
Description
Assessed using the Spence Anxiety Scale for Preschoolers (Spence, Rapee, McDonald, & Ingram, 2001). This 34-item parent-report scale provides an overall measure of child anxiety.
Time Frame
approximately 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
48 Months
Maximum Age & Unit of Time
83 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate D Fitzgerald, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Muzik, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kate Rosenblum, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jason Moser, PhD
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35708131
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.
Results Reference
derived

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Neurally Targeted Interventions to Reduce Early Childhood Anxiety

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