AnxietyAPSUNCT06977178
Adverse Adolescent Pathways to Substance Use
A study testing Trier Social Stress Test in people with Anxiety and Adolescent Development, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: This 5-year R01 study will elucidate the role of maturational change across adolescence in neural connectivity and physiological stress responses in the relationship between anxiety and adverse pathways to substance use (APSU). Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Adolescent Development, Substance Use
- What is being tested?
- Trier Social Stress Test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2024to 30 Jun 2030
- 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 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female
- 12-14 years old,
- Report symptoms of anxiety
- Understand and sign an assent, and parents will sign a permission and a consent document in English
- Meets study hearing and vision requirements
- Substance use naïve
Who cannot join
- Has any foreign metal objects or implants as determined by the safety questionnaires (e.g., bone screws, shunts or body piercing that can't be removed, etc.)
- Has been diagnosed with psychosis or a severe emotional disturbance.
- Has used alcohol, tobacco, or marijuana more than 3 times.
- Is pregnant. Girls who self-report pregnancy may not participate in the stress evaluation or the MRI scan.
- Is taking any medications that directly alter cardiovascular function (e.g., propranolol or other beta blockers).
- Any current or lifetime treatment with antipsychotic medication.
Show all 10Show fewer
- Has had a head injury that resulted in a loss of consciousness for more than 5 minutes.
- Is planning to get non-removable metal braces.
- Impaired intellectual functioning (full-scale intelligence quotient <70).
- Past or current history of a clinically significant central nervous system that could confound brain imaging evaluations.
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
The University of North Carolina at Chapel Hill School of Medicine
Chapel Hill, North Carolina, 27599
Aysenil Belger, PhD, aysenil.belger@unc.edu
Aysenil Belger, PhD
About this study
Purpose: This 5-year R01 study will elucidate the role of maturational change across adolescence in neural connectivity and physiological stress responses in the relationship between anxiety and adverse pathways to substance use (APSU). Participants: Children (N=200) aged 12-14 with symptoms of anxiety and their legal caregiver will be recruited from clinical and community sources. Procedures: Youth participants will complete several questionnaires and interviews, undergo neuroimaging while performing cognitive tasks, and have their heart rate and skin conductance monitored during a mildly stressful task. Caregivers will complete several questionnaires.
Read the detailed description
The conceptual model proposes that the relationship between anxiety symptomatology and Adverse Patterns of Substance Use (APSU: age of onset, cumulative exposure, severity, and polydrug use) is a function of acute stress reactivity that is underpinned by specific neurobiological and neurocognitive factors measurable at a drug- and alcohol-naïve baseline. Youth at high risk for APSU will be over-sampled using parent and child-reported screeners that include items relating to emotion dysregulation, behavioral impulsivity, susceptibility to peer pressure, friends' conduct problems, and other risk-relevant characteristics to define a high-APSU-risk prodrome. Risk status will be measured as a continuous trait using well-tested thresholds for high and low risk for APSU, and the recruitment strategy will ensure sufficient variability on this axis. This approach ensures a sufficient number of youth will initiate and escalate SU within the time frame of the study, allowing the investigators to assess precursors APSU in high risk youth as a function of anxiety symptomatology and acute stress reactivity, using feasible and adequately powered methods.
To test hypotheses, the investigators will prospectively assess acute stress responsivity, anxiety symptoms, specific neural connectivity patterns, and APSU in a sample of 180 substance-naïve youth beginning in early adolescence (age 12-14, Tanner Stage >3) and two additional 12 month waves of data collection. Participants will complete an acute stress task outside the scanner with psychophysiological monitoring and a resting and performance based MRI session using impulsivity (fronto-striatal-thalamic circuitry), negative valence (threat circuitry), and attention bias (shifting from threat to frontal circuitry) tasks. At each wave, all surveys, cognitive tests, stress physiological, clinical and neuroimaging measures will be assessed. A final online exit survey in year 5 will be conducted simultaneously for all participants to evaluate clinical symptoms and end-point APSU.
The proposed prospective, longitudinal design is novel, creative, and timely. Brain imaging studies of this type are typically quite small, often due to cost limitations, and are only able to accurately model a small subset of factors and covariates. The investigators plan to evaluate the complexity of the problem with targeted variables that will be well-defined in the sample and tracked over time in relation to APSU in an atypically large sample for neuroimaging. This design will enable within- and between-subject comparisons that prospectively: (1) characterize substance use pathways (e.g., nature and extent of use over time) in the context of neurobiological and neurocognitive mechanisms associated with physiological responses to acute stress that underlie anxiety symptoms, (2) tracks developmental change in these processes, and (3) differentiates between potentially distinctive neural pathways that influence progression to APSU.
- Conditions
- Anxiety, Adolescent Development, Substance Use
- Being tested
- Trier Social Stress Test
- Medical subject headings
- Anxiety Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trier Social Stress TestBehavioural
Psychosocial stress procedure; 5 minutes of public speaking (preceded by 5 minutes of preparation) and 5 minutes of mental arithmetic.
| Study group | Role | What they receive |
|---|---|---|
| Trier Social Stress Test (TSST) | Experimental | The Trier Social Stress Test for Children (TSST-C) is a social stressor involving story telling in front of two neutral judges, preparation time and a cognitive stressor involving mental arithmetic-counting backward from 1023 by 13s. It is used to elicit physiological stress responses. The TSST-C is administered in 4 parts: an anticipatory stress phase (5 min to prepare the speech); the speech task (5 min), the arithmetic task (5 min), and the recovery phase (up through 40 min post-task). Receives: Behavioral: Trier Social Stress Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction time during the functional magnetic resonance imaging (FMRI) Stop Signal Task
The Stop Signal Task is a measure of inhibitory control. Participants are presented with a right or left arrow and instructed to press one of two buttons corresponding with each arrow after it is presented. However, on certain trials, there is an up facing arrow immediately following the presentation of a left or right arrow, and participants are instructed to not press any buttons if they see an up arrow. The task measures the mean go reaction time to evaluate the participant's ability to inhibit when the up arrow is presented, with faster reaction times (measured in milliseconds) meaning lower inhibition.
Measured: baseline, 12-months, 24-months
Percent signal change during the FMRI Stop Signal Task
Neural activation during the Stop Signal Task is measured through determining the percent signal change from baseline FMRI resting state to neural activation during the Stop Signal Task, particularly in the front-striatal-thalamic regions. Higher percent signal change would indicate higher levels of activation during the task. Percent signal change ranges between 1% to 5%.
Measured: baseline, 12-months, 24-months
Percent signal change activation during the No-stimuli, Predictable-stimuli, and Unpredictable-stimuli (NPU) task
In the NPU task, participants are presented with fearful and neutral faces, with the fearful face presentation being sometimes cued with another associated visual stimuli immediately beforehand, and sometimes uncued and therefore unpredicted. This task measures cued anticipation of threat. The regions of interest are the intra-limbic regions, bed nucleus of the stria terminalis (BNST), and the amygdala. Higher percent signal change in these regions would indicate higher levels of activation during the task. Percent signal change ranges between 1% to 5%.
Measured: baseline, 12-months, 24-months
Percent signal change during the Attentional Load Paradigm (ALP) task
In the ALP task, participants complete a letter search task while being presented with peripheral distractor letters on top of both fearful and neutral faces to evaluate the impact of perceptual load on the neural response to fearful vs neutral face distractors. The percent signal change will be specifically analyzed in the parietal and frontal cortices. Higher percent signal change in these regions would indicate higher levels of activation during the task. In addition, the ability to shift from affective-limbic to cognitive-pre-frontal cortex to complete the task will be evaluated as a key indicator of neural maturity. Percent signal change ranges between 1% to 5%.
Measured: baseline, 12-months, 24-months
Percent signal change during Emotional Face N-Back (EFNBack)
In the EFNBack task, participants are shown images of emotionally salient (happy and fearful) and neutral faces as well as images of neutral places. Participants are instructed to determine whether each picture presented is a "Match" or a "No match". In the 0-back, low load condition, the "match" occurs when the picture presented is the same as a fixed target picture presented at the beginning. In the 2-back, high load condition, the "match" occurs when the picture presented is the same as the one shown two pictures ago. This task evaluates working memory and emotional regulation, as well as the percent signal change of the prefrontal cortex (PFC), amygdala, and anterior cingulate cortex (ACC), with higher percent signal change in these regions indicating higher levels of activation during the task. Percent signal change ranges between 1% to 5%.
Measured: baseline, 12-months, 24-months
Sympathetic and Parasympathetic nervous system ECG activation or heart rate variability (HRV) during a psychosocial stressful task (Trier Social Stress Test - TSST)
The Trier Social Stress Test for Children (TSST-C) -- a social stressor involving story telling in front of two neutral judges, preparation time and a cognitive stressor involving mental arithmetic-counting backward from 1023 by 13s -- is used to elicit physiological stress responses. The combination of stressors offers high levels of social-evaluative threat. The TSST-C will be administered in 4 parts: an anticipatory stress phase (5 min to prepare the speech); the speech task (5 min), the arithmetic task (5 min), and the recovery phase (up through 40 min post-task). For a five minute baseline period, and for the duration of the task, heart rate is measured to determine baseline resting state and HRV. HRV is the difference in the milliseconds between each heart beat. The higher the HRV, the more the nervous system is activated during the task. The level of HRV indicates the participant's nervous system response to stress.
Measured: at baseline, 12-month and 24-month
Endocrine (cortisol) measures during a psychosocial stressful task (Trier Social Stress Test - TSST)
The Trier Social Stress Test for Children (TSST-C) -- a social stressor involving story telling in front of two neutral judges, preparation time and a cognitive stressor involving mental arithmetic-counting backward from 1023 by 13s-- is used to elicit physiological stress responses. The combination of these stressors offers elements of uncontrollability and high levels of social-evaluative threat. The TSST-C will be administered in 4 parts: an anticipatory stress phase (5 min to prepare the speech); the speech task (5 min), the arithmetic task (5 min), and the recovery phase (up through 40 min post-task). At rest, cortisol is collected through a saliva sample of passive drool. Then cortisol will be collected in 15 minute intervals for the duration of the task and recovery time. The higher the cortisol is found to be, the higher the stress response to the task.
Measured: at baseline, 12-month and 24-month
Assessment of Liability and Exposure to Substance Use and Antisocial Behavior, Revised (ALEXSA-R)
The Assessment of Liability and Exposure to Substance use and Antisocial behavior, Revised (ALEXSA-R) is a system of youth-report measures of risks, resiliencies, risky health behavior. The youth-report Youth Risk Index (YRI) which is part of the ALEXSA-R will be used to screen for participants who are at high and low risk for early- to mid-adolescent problematic substance use. The YRI screening tool is designed for well-child visits to identify at-risk youths and refer them for prevention. The higher the YRI score (range 0-3) the higher the youth risk level.
Measured: at baseline, 12-month and 24-month
Neurocognitive testing and executive functioning through NIH Toolbox
Neurodevelopmental maturity and cognitive functioning will be evaluated with NIH Cognitive Toolbox - Child Computerized performance tasks. These tasks test decision making, impulsivity, working memory, and attention. There is a memory task involving remembering the sequence of words, there is an inhibitory task involving pressing only certain buttons, and an attention task involving determining which pictures match and which do not. Each task produces a t score, with higher scores indicating higher performance on each task.
Measured: at baseline, 12-month and 24-month
Multidimensional Anxiety Scale for Children 2 (MASC2)
The MASC2 is a comprehensive assessment of anxiety. It is a self-report scale for youth ages 8-19 with 50 items. It measures symptom severity, as well as range of symptoms across possible anxiety disorders and produces a t score which represents anxiety severity. This score can range from less than 40 (a low score) to above 70 (a high score).
Measured: at baseline, 12-month and 24-month
State-Trait Anxiety Inventory for Children (STAI-C)
The STAI-C is a measure with two sub-surveys, with each one having 20 items each. The State measure assesses current anxiety at the moment of assessment, with a higher score meaning higher current anxiety. The Trait measure assesses level of anxiety severity in general as a trait of the participant, with a higher score meaning higher overall anxiety. The range in scores is between 20-80 for each sub-survey.
Measured: at baseline, 12-month and 24-month
Tobacco Alcohol and Drug Use Survey
Self-report survey to assess the frequency of use of multiple drugs: e.g., tobacco, alcohol, marijuana, cocaine, methamphetamine, opioids, etc. as the primary initial tool to assess what substances have been used by participants. This measure produces the number of days in the past year that the participant has used a substance as well as how recently the participant has used a substance.
Measured: 12-month and 24-month
Secondary outcomes (2)
Age
Participant age is used as a secondary outcome to determine the impact of age on the primary outcome measures. Participant age falls in the range of 12-17.
Measured: at baseline, 12-month and 24-month
Adverse Life Experiences
The Adverse Life Experiences Scale (ALES) is used to assess experiences of adversity, abuse, neglect, and threat. It will be used as a secondary outcome to determine the impact of adverse life experiences on the primary outcome measures. The number of adverse experiences reported by each participant is totaled, with the higher number of experiences meaning a higher level of adversity.
Measured: at baseline, 12-month and 24-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start20 Feb 2024
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The Trier Social Stress Test for Children (TSST-C 61)-- a social stressor involving story telling in front of two neutral judges, preparation time and a cognitive stressor involving mental arithmetic-counting backward from 1023 by 13s--will be used to elicit physiological stress responses.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), RTI International
- Responsible party
- Sponsor
- Investigators
- Aysenil Belger, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977178
- Sponsor's protocol ID
- 23-1572
- Other IDs
- 5R01DA057312-02
- Acronym
- APSU
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As part of the federal funding for this grant, participant's de-identified data will be uploaded to the NIMH data archive. The NIH-funded research data repository aims to accelerate progress in clinical research through data sharing, data harmonization, and the reporting of research results. It also serves as a scientific community platform and portal to multiple other research repositories, allowing for aggregation and secondary analysis of data. NDA is a data repository run by the National Institute of Mental Health (NIMH) that allows researchers studying mental health problems to collect and share de-identified information with each other.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Adolescent Pathways to Substance Use
- ClinicalTrials.gov ID
- NCT06977178
- Acronym / sponsor ID
- APSU / 23-1572
- Conditions
- Anxiety, Adolescent Development, Substance Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), RTI International
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 18 May 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.
Purpose: This 5-year R01 study will elucidate the role of maturational change across adolescence in neural connectivity and physiological stress responses in the relationship between anxiety and adverse pathways to substance use (APSU). Participants: Children (N=200) aged 12-14 with symptoms of anxiety and their legal caregiver will be recruited from clinical and community sources. Procedures: Youth participants will complete several questionnaires and interviews, undergo neuroimaging while performing cognitive tasks, and have their heart rate and skin conductance monitored during a mildly stressful task. Caregivers will complete several questionnaires.
Detailed description
The conceptual model proposes that the relationship between anxiety symptomatology and Adverse Patterns of Substance Use (APSU: age of onset, cumulative exposure, severity, and polydrug use) is a function of acute stress reactivity that is underpinned by specific neurobiological and neurocognitive factors measurable at a drug- and alcohol-naïve baseline. Youth at high risk for APSU will be over-sampled using parent and child-reported screeners that include items relating to emotion dysregulation, behavioral impulsivity, susceptibility to peer pressure, friends' conduct problems, and other risk-relevant characteristics to define a high-APSU-risk prodrome. Risk status will be measured as a continuous trait using well-tested thresholds for high and low risk for APSU, and the recruitment strategy will ensure sufficient variability on this axis. This approach ensures a sufficient number of youth will initiate and escalate SU within the time frame of the study, allowing the investigators to assess precursors APSU in high risk youth as a function of anxiety symptomatology and acute stress reactivity, using feasible and adequately powered methods.
To test hypotheses, the investigators will prospectively assess acute stress responsivity, anxiety symptoms, specific neural connectivity patterns, and APSU in a sample of 180 substance-naïve youth beginning in early adolescence (age 12-14, Tanner Stage >3) and two additional 12 month waves of data collection. Participants will complete an acute stress task outside the scanner with psychophysiological monitoring and a resting and performance based MRI session using impulsivity (fronto-striatal-thalamic circuitry), negative valence (threat circuitry), and attention bias (shifting from threat to frontal circuitry) tasks. At each wave, all surveys, cognitive tests, stress physiological, clinical and neuroimaging measures will be assessed. A final online exit survey in year 5 will be conducted simultaneously for all participants to evaluate clinical symptoms and end-point APSU.
The proposed prospective, longitudinal design is novel, creative, and timely. Brain imaging studies of this type are typically quite small, often due to cost limitations, and are only able to accurately model a small subset of factors and covariates. The investigators plan to evaluate the complexity of the problem with targeted variables that will be well-defined in the sample and tracked over time in relation to APSU in an atypically large sample for neuroimaging. This design will enable within- and between-subject comparisons that prospectively: (1) characterize substance use pathways (e.g., nature and extent of use over time) in the context of neurobiological and neurocognitive mechanisms associated with physiological responses to acute stress that underlie anxiety symptoms, (2) tracks developmental change in these processes, and (3) differentiates between potentially distinctive neural pathways that influence progression to APSU.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The Trier Social Stress Test for Children (TSST-C 61)-- a social stressor involving story telling in front of two neutral judges, preparation time and a cognitive stressor involving mental arithmetic-counting backward from 1023 by 13s--will be used to elicit physiological stress responses.
| Arm | Type | Receives |
|---|---|---|
| Trier Social Stress Test (TSST) | Experimental | Behavioral: Trier Social Stress TestThe Trier Social Stress Test for Children (TSST-C) is a social stressor involving story telling in front of two neutral judges, preparation time and a cognitive stressor involving mental arithmetic-counting backward from 1023 by 13s. It is used to elicit physiological stress responses. The TSST-C is administered in 4 parts: an anticipatory stress phase (5 min to prepare the speech); the speech task (5 min), the arithmetic task (5 min), and the recovery phase (up through 40 min post-task). |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female
- 12-14 years old,
- Report symptoms of anxiety
- Understand and sign an assent, and parents will sign a permission and a consent document in English
- Meets study hearing and vision requirements
Key exclusion criteria (10 listed)
- Has any foreign metal objects or implants as determined by the safety questionnaires (e.g., bone screws, shunts or body piercing that can't be removed, etc.)
- Has been diagnosed with psychosis or a severe emotional disturbance.
- Has used alcohol, tobacco, or marijuana more than 3 times.
- Is pregnant. Girls who self-report pregnancy may not participate in the stress evaluation or the MRI scan.
- Is taking any medications that directly alter cardiovascular function (e.g., propranolol or other beta blockers).
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 |
|---|---|---|
| Trier Social Stress TestPsychosocial stress procedure; 5 minutes of public speaking (preceded by 5 minutes of preparation) and 5 minutes of mental arithmetic. | Behavioural | Trier Social Stress Test (TSST) |
Primary outcome
Reaction time during the functional magnetic resonance imaging (FMRI) Stop Signal Task
Time frame: baseline, 12-months, 24-months
The Stop Signal Task is a measure of inhibitory control. Participants are presented with a right or left arrow and instructed to press one of two buttons corresponding with each arrow after it is presented. However, on certain trials, there is an up facing arrow immediately following the presentation of a left or right arrow, and participants are instructed to not press any buttons if they see an up arrow. The task measures the mean go reaction time to evaluate the participant's ability to inhibit when the up arrow is presented, with faster reaction times (measured in milliseconds) meaning lower inhibition.
Percent signal change during the FMRI Stop Signal Task
Time frame: baseline, 12-months, 24-months
Neural activation during the Stop Signal Task is measured through determining the percent signal change from baseline FMRI resting state to neural activation during the Stop Signal Task, particularly in the front-striatal-thalamic regions. Higher percent signal change would indicate higher levels of activation during the task. Percent signal change ranges between 1% to 5%.
Percent signal change activation during the No-stimuli, Predictable-stimuli, and Unpredictable-stimuli (NPU) task
Time frame: baseline, 12-months, 24-months
In the NPU task, participants are presented with fearful and neutral faces, with the fearful face presentation being sometimes cued with another associated visual stimuli immediately beforehand, and sometimes uncued and therefore unpredicted. This task measures cued anticipation of threat. The regions of interest are the intra-limbic regions, bed nucleus of the stria terminalis (BNST), and the amygdala. Higher percent signal change in these regions would indicate higher levels of activation during the task. Percent signal change ranges between 1% to 5%.
Percent signal change during the Attentional Load Paradigm (ALP) task
Time frame: baseline, 12-months, 24-months
In the ALP task, participants complete a letter search task while being presented with peripheral distractor letters on top of both fearful and neutral faces to evaluate the impact of perceptual load on the neural response to fearful vs neutral face distractors. The percent signal change will be specifically analyzed in the parietal and frontal cortices. Higher percent signal change in these regions would indicate higher levels of activation during the task. In addition, the ability to shift from affective-limbic to cognitive-pre-frontal cortex to complete the task will be evaluated as a key indicator of neural maturity. Percent signal change ranges between 1% to 5%.
Percent signal change during Emotional Face N-Back (EFNBack)
Time frame: baseline, 12-months, 24-months
In the EFNBack task, participants are shown images of emotionally salient (happy and fearful) and neutral faces as well as images of neutral places. Participants are instructed to determine whether each picture presented is a "Match" or a "No match". In the 0-back, low load condition, the "match" occurs when the picture presented is the same as a fixed target picture presented at the beginning. In the 2-back, high load condition, the "match" occurs when the picture presented is the same as the one shown two pictures ago. This task evaluates working memory and emotional regulation, as well as the percent signal change of the prefrontal cortex (PFC), amygdala, and anterior cingulate cortex (ACC), with higher percent signal change in these regions indicating higher levels of activation during the task. Percent signal change ranges between 1% to 5%.
Sympathetic and Parasympathetic nervous system ECG activation or heart rate variability (HRV) during a psychosocial stressful task (Trier Social Stress Test - TSST)
Time frame: at baseline, 12-month and 24-month
The Trier Social Stress Test for Children (TSST-C) -- a social stressor involving story telling in front of two neutral judges, preparation time and a cognitive stressor involving mental arithmetic-counting backward from 1023 by 13s -- is used to elicit physiological stress responses. The combination of stressors offers high levels of social-evaluative threat. The TSST-C will be administered in 4 parts: an anticipatory stress phase (5 min to prepare the speech); the speech task (5 min), the arithmetic task (5 min), and the recovery phase (up through 40 min post-task). For a five minute baseline period, and for the duration of the task, heart rate is measured to determine baseline resting state and HRV. HRV is the difference in the milliseconds between each heart beat. The higher the HRV, the more the nervous system is activated during the task. The level of HRV indicates the participant's nervous system response to stress.
Endocrine (cortisol) measures during a psychosocial stressful task (Trier Social Stress Test - TSST)
Time frame: at baseline, 12-month and 24-month
The Trier Social Stress Test for Children (TSST-C) -- a social stressor involving story telling in front of two neutral judges, preparation time and a cognitive stressor involving mental arithmetic-counting backward from 1023 by 13s-- is used to elicit physiological stress responses. The combination of these stressors offers elements of uncontrollability and high levels of social-evaluative threat. The TSST-C will be administered in 4 parts: an anticipatory stress phase (5 min to prepare the speech); the speech task (5 min), the arithmetic task (5 min), and the recovery phase (up through 40 min post-task). At rest, cortisol is collected through a saliva sample of passive drool. Then cortisol will be collected in 15 minute intervals for the duration of the task and recovery time. The higher the cortisol is found to be, the higher the stress response to the task.
Assessment of Liability and Exposure to Substance Use and Antisocial Behavior, Revised (ALEXSA-R)
Time frame: at baseline, 12-month and 24-month
The Assessment of Liability and Exposure to Substance use and Antisocial behavior, Revised (ALEXSA-R) is a system of youth-report measures of risks, resiliencies, risky health behavior. The youth-report Youth Risk Index (YRI) which is part of the ALEXSA-R will be used to screen for participants who are at high and low risk for early- to mid-adolescent problematic substance use. The YRI screening tool is designed for well-child visits to identify at-risk youths and refer them for prevention. The higher the YRI score (range 0-3) the higher the youth risk level.
Neurocognitive testing and executive functioning through NIH Toolbox
Time frame: at baseline, 12-month and 24-month
Neurodevelopmental maturity and cognitive functioning will be evaluated with NIH Cognitive Toolbox - Child Computerized performance tasks. These tasks test decision making, impulsivity, working memory, and attention. There is a memory task involving remembering the sequence of words, there is an inhibitory task involving pressing only certain buttons, and an attention task involving determining which pictures match and which do not. Each task produces a t score, with higher scores indicating higher performance on each task.
Multidimensional Anxiety Scale for Children 2 (MASC2)
Time frame: at baseline, 12-month and 24-month
The MASC2 is a comprehensive assessment of anxiety. It is a self-report scale for youth ages 8-19 with 50 items. It measures symptom severity, as well as range of symptoms across possible anxiety disorders and produces a t score which represents anxiety severity. This score can range from less than 40 (a low score) to above 70 (a high score).
State-Trait Anxiety Inventory for Children (STAI-C)
Time frame: at baseline, 12-month and 24-month
The STAI-C is a measure with two sub-surveys, with each one having 20 items each. The State measure assesses current anxiety at the moment of assessment, with a higher score meaning higher current anxiety. The Trait measure assesses level of anxiety severity in general as a trait of the participant, with a higher score meaning higher overall anxiety. The range in scores is between 20-80 for each sub-survey.
Tobacco Alcohol and Drug Use Survey
Time frame: 12-month and 24-month
Self-report survey to assess the frequency of use of multiple drugs: e.g., tobacco, alcohol, marijuana, cocaine, methamphetamine, opioids, etc. as the primary initial tool to assess what substances have been used by participants. This measure produces the number of days in the past year that the participant has used a substance as well as how recently the participant has used a substance.
2 secondary outcomes
Age
Time frame: at baseline, 12-month and 24-month
Adverse Life Experiences
Time frame: at baseline, 12-month and 24-month
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 18 May 2025.
- Individual participant dataSharing planned: Yes. As part of the federal funding for this grant, participant's de-identified data will be uploaded to the NIMH data archive. The NIH-funded research data repository aims to accelerate progress in clinical research through data sharing, data harmonization, and the reporting of research results. It also serves as a scientific community platform and portal to multiple other research repositories, allowing for aggregation and secondary analysis of data. NDA is a data repository run by the National Institute of Mental Health (NIMH) that allows researchers studying mental health problems to collect and share de-identified information with each other.
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Anxiety Symptoms, Anxiety Disorders
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Not yet recruiting
AI-Based CBT Chatbot for Adolescent Social Anxiety
AI-CBT Intervention Group, Waitlist Control Group
Not yet recruitingObservational study
Music Therapy and Sedation for Pain and Anxiety During Oocyte Retrieval
ANXIETY
Active, not recruiting
Relaxation Techniques and Pilates for Menopause Symptoms
Women Over 40 Years of Age in the Perimenopausal or Menopausal Stage, Presenting With Associated Symptoms
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.
Aysenil Belger, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trier Social Stress Test in people with Anxiety and Adolescent Development, run by University of North Carolina, Chapel Hill 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 6 inclusion and 10 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 18 May 2025. 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 Aysenil Belger, PhD ((919)-260-9822, aysenil.belger@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction time during the functional magnetic resonance imaging (FMRI) Stop Signal Task (time frame: baseline, 12-months, 24-months). The study lists 12 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 18 May 2025.