Anxiety DisordersNCT03093376
Neurally Targeted Interventions to Reduce Early Childhood Anxiety
A study of Anxiety Disorders, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 48 to 83 months
- Conditions the study is for
- Anxiety Disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2017to 29 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 83 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 4.0 and 6.99 years
- Child has current anxiety symptoms
- Parent/caregiver is English-speaking.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Effortful Control Camp
- Keywords
- Anxiety, Effortful Control, Preschool, ERN
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effortful Control CampBehavioural
Also called EC 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Effortful Control Camp |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: approximately 10 weeks
Secondary outcomes (1)
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.
Measured: approximately 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start30 Mar 2017
- Primary completion6 Mar 2020
- Study completion29 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Child participants receive effortful control (EC) training.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan State University, One Mind Institute
- Responsible party
- Principal investigator, Kate D. Fitzgerald, University of Michigan
- Investigators
- Kate D Fitzgerald, MD, Principal investigator, University of MichiganMaria Muzik, MD, Principal investigator, University of MichiganKate Rosenblum, PhD, Principal investigator, University of MichiganJason Moser, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093376
- Sponsor's protocol ID
- HUM00117593
- Status last verified
- Aug 2021
- First submitted
- 30 Jan 2017
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35708131
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurally Targeted Interventions to Reduce Early Childhood Anxiety
- ClinicalTrials.gov ID
- NCT03093376
- Acronym / sponsor ID
- HUM00117593
- Conditions
- Anxiety Disorders
- Keywords
- Anxiety, Effortful Control, Preschool, ERN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Michigan State University, One Mind Institute
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 29 Oct 2020 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Child participants receive effortful control (EC) training.
| Arm | Type | Receives |
|---|---|---|
| Effortful Control Camp | Experimental | Behavioral: Effortful Control CampChildren 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. |
Who may qualify
- Ages
- 48 to 83 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children between 4.0 and 6.99 years
- Child has current anxiety symptoms
- Parent/caregiver is English-speaking.
Key exclusion criteria (8 listed)
- Child cannot be currently taking medications that affect central nervous system functioning.
- No history of:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effortful Control CampAlso: EC CampAn 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. | Behavioural | Effortful Control Camp |
Primary outcome
Change from Baseline Error Related Negativity (ERN) at Post-Intervention
Time frame: approximately 10 weeks
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
Time frame: approximately 10 weeks
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.
1 secondary outcome
Change in Anxiety Symptoms
Time frame: approximately 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Derived from this study: PubMed 35708131Schroder 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate D Fitzgerald, MD principal investigator
University of Michigan
Maria Muzik, MD principal investigator
University of Michigan
Kate Rosenblum, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Anxiety Disorders, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Error Related Negativity (ERN) at Post-Intervention (time frame: approximately 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03093376, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.