Neurally Targeted Interventions to Reduce Early Childhood Anxiety

NCT ID: NCT03093376

Last Updated: 2021-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-30
• Study Completion Date: 2020-10-29

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.

Conditions

Anxiety Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Effortful Control Camp

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.

Group Type: EXPERIMENTAL

Effortful Control Camp

Intervention Type: 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.

Interventions

Effortful Control Camp

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

EC Camp

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

• Minimum Eligible Age: 48 Months
• Maximum Eligible Age: 83 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michigan State University

OTHER

Sponsor Role: collaborator

One Mind Institute

UNKNOWN

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Kate D. Fitzgerald

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kate D Fitzgerald, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Maria Muzik, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Kate Rosenblum, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Jason Moser, PhD

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35708131 (View on PubMed)

Other Identifiers

HUM00117593

Identifier Type: -

Identifier Source: org_study_id