Depression, AnxietyNCT07296939
Youth Emotional and Behavioral Treatment Study
A study testing Cognitive Behavioral Therapy in people with Depression, Anxiety, run by Florida State University at 1 site in United States.
Trial summary
This study aims to characterize key mechanisms underlying the development, maintenance, and treatment of severe irritability in a clinically heterogeneous sample of school-aged youth. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 4-17 years
- (a) a principal diagnosis of an anxiety or mood disorder per DSM-5 criteria, OR (b) parent report of clinically impairing irritability, emotional dysregulation, and/or disruptive behavior in youth
- Child and parent must be able to complete consent documents, assessments, and participate in treatment in English without a translator
- At least one parent must be available and willing to participant in both phases.
Who cannot join
- Gross neurological, sensory, or motor impairment
- History of seizure disorder, psychosis, or organic brain syndrome
- Conditions requiring acute intervention, e.g., active suicidality
- Non-English speaking child or parent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Florida State University
Tallahassee, Florida, 32304
Harmon Youth Lab, 8506458724, harmonylab@psy.fsu.edu
About this study
Official title: Psychological Assessment and Treatment of Youth Emotional and Behavioral Dysregulation
This study aims to characterize key mechanisms underlying the development, maintenance, and treatment of severe irritability in a clinically heterogeneous sample of school-aged youth.
Read the detailed description
Severe irritability in youth is associated with significant functional impairment and occurs across diagnostic categories. This study aims to characterize key mechanisms underlying the development, maintenance, and treatment of severe irritability in a clinically heterogeneous sample of school-aged youth. Participants will complete (a) a comprehensive, multimodal assessment - including diagnostic interviews, multi-informant behavioral ratings, and neurophysiological tasks - to evaluate core cognitive, behavioral, and psychosocial factors, and (b) evidence-based treatment (e.g., cognitive behavioral therapy). Repeated assessments throughout the study period will be used to evaluate study outcomes.
- Conditions
- Depression, Anxiety
- Being tested
- Cognitive Behavioral Therapy
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Participants will receive evidence-based treatment designed to address a wide range of emotional disorders.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impressions - Improvement Scale
Clinician-rated assessment of overall clinical change, with scores ranging from 1 (very much improved) to 7 (very much worse).
Measured: Post-treatment (up to 28 weeks from baseline)
Affective Reactivity Index
Youth- and caregiver-reported measure of irritability, with total scores ranging from 0 to 12; higher scores indicate greater symptom severity.
Measured: Baseline to post-treatment (up to 28 weeks)
Secondary outcomes (4)
Behavior Assessment System for Children
Youth- and caregiver-reported measure of behavioral and emotional functioning; T-scores of 70 or higher indicate clinically significant symptoms.
Measured: Baseline to post-treatment (up to 28 weeks)
Stop-Signal
Computerized task assessing inhibitory control in youth participants; longer stop-signal reaction times reflect slower inhibitory control.
Measured: Baseline to post-treatment (up to 28 weeks)
Global-Local
Computerized task assessing set-shifting in youth participants; longer reaction times indicate poorer performance.
Measured: Baseline to post-treatment (up to 28 weeks)
Letter Updating
Computerized task assessing working memory updating in youth participants; higher scores indicate better updating abilities.
Measured: Baseline to post-treatment (up to 28 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start7 May 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe 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
- Standard evidence-based intervention based on child's primary diagnosis.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Sherelle Harmon, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296939
- Sponsor's protocol ID
- STUDY00005777
- Other IDs
- U54CA267730
- Status last verified
- Jan 2026
- First submitted
- 12 Dec 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Assessment and Treatment of Youth Emotional and Behavioral Dysregulation
- ClinicalTrials.gov ID
- NCT07296939
- Acronym / sponsor ID
- STUDY00005777
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 May 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 22 Dec 2025 (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.
This study aims to characterize key mechanisms underlying the development, maintenance, and treatment of severe irritability in a clinically heterogeneous sample of school-aged youth.
Detailed description
Severe irritability in youth is associated with significant functional impairment and occurs across diagnostic categories. This study aims to characterize key mechanisms underlying the development, maintenance, and treatment of severe irritability in a clinically heterogeneous sample of school-aged youth. Participants will complete (a) a comprehensive, multimodal assessment - including diagnostic interviews, multi-informant behavioral ratings, and neurophysiological tasks - to evaluate core cognitive, behavioral, and psychosocial factors, and (b) evidence-based treatment (e.g., cognitive behavioral therapy). Repeated assessments throughout the study period will be used to evaluate study outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Standard evidence-based intervention based on child's primary diagnosis.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Cognitive Behavioral Therapy |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children between the ages of 4-17 years
- (a) a principal diagnosis of an anxiety or mood disorder per DSM-5 criteria, OR (b) parent report of clinically impairing irritability, emotional dysregulation, and/or disruptive behavior in youth
- Child and parent must be able to complete consent documents, assessments, and participate in treatment in English without a translator
- At least one parent must be available and willing to participant in both phases.
Key exclusion criteria (4 listed)
- Gross neurological, sensory, or motor impairment
- History of seizure disorder, psychosis, or organic brain syndrome
- Conditions requiring acute intervention, e.g., active suicidality
- Non-English speaking child or parent
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 |
|---|---|---|
| Cognitive Behavioral TherapyParticipants will receive evidence-based treatment designed to address a wide range of emotional disorders. | Behavioural | Treatment Group |
Primary outcome
Clinical Global Impressions - Improvement Scale
Time frame: Post-treatment (up to 28 weeks from baseline)
Clinician-rated assessment of overall clinical change, with scores ranging from 1 (very much improved) to 7 (very much worse).
Affective Reactivity Index
Time frame: Baseline to post-treatment (up to 28 weeks)
Youth- and caregiver-reported measure of irritability, with total scores ranging from 0 to 12; higher scores indicate greater symptom severity.
4 secondary outcomes
Behavior Assessment System for Children
Time frame: Baseline to post-treatment (up to 28 weeks)
Stop-Signal
Time frame: Baseline to post-treatment (up to 28 weeks)
Global-Local
Time frame: Baseline to post-treatment (up to 28 weeks)
Letter Updating
Time frame: Baseline to post-treatment (up to 28 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Depression, Anxiety, run by Florida State University 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 14 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherelle Harmon, PhD (18506458724, harmonylab@psy.fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impressions - Improvement Scale (time frame: Post-treatment (up to 28 weeks from baseline)). 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?
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 14 May 2026.