Recruiting

Observational Study

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06977178

Conditions

Anxiety

Adolescent Development

Substance Use

Eligibility Criteria

Sex: All

Age: 12 - 14

Healthy Volunteers: Accepted

Interventions

Trier Social Stress Test

Study Details

Brief 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). 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.

Conditions

Anxiety

Adolescent Development

Substance Use

Study ID

NCT06977178

Start date

Feb 20, 2024

Status verified date

Oct, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 14

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

180 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Trier Social Stress Test (TSST)

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).

Interventions

Trier Social Stress Test

Psychosocial stress procedure; 5 minutes of public speaking (preceded by 5 minutes of preparation) and 5 minutes of mental arithmetic.

Primary outcome measure

  • Reaction time during the functional magnetic resonance imaging (FMRI) Stop Signal Task [ Time Frame: baseline, 12-months, 24-months ]
  • Percent signal change during the FMRI Stop Signal Task [ Time Frame: baseline, 12-months, 24-months ]
  • Percent signal change activation during the No-stimuli, Predictable-stimuli, and Unpredictable-stimuli (NPU) task [ Time Frame: baseline, 12-months, 24-months ]
  • Percent signal change during the Attentional Load Paradigm (ALP) task [ Time Frame: baseline, 12-months, 24-months ]
  • Percent signal change during Emotional Face N-Back (EFNBack) [ Time Frame: 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) [ Time Frame: at baseline, 12-month and 24-month ]
  • Endocrine (cortisol) measures during a psychosocial stressful task (Trier Social Stress Test - TSST) [ Time Frame: at baseline, 12-month and 24-month ]
  • Assessment of Liability and Exposure to Substance Use and Antisocial Behavior, Revised (ALEXSA-R) [ Time Frame: at baseline, 12-month and 24-month ]
  • Neurocognitive testing and executive functioning through NIH Toolbox [ Time Frame: at baseline, 12-month and 24-month ]
  • Multidimensional Anxiety Scale for Children 2 (MASC2) [ Time Frame: at baseline, 12-month and 24-month ]
  • State-Trait Anxiety Inventory for Children (STAI-C) [ Time Frame: at baseline, 12-month and 24-month ]
  • Tobacco Alcohol and Drug Use Survey [ Time Frame: 12-month and 24-month ]

Central Contacts and Locations

Central contacts

Aysenil Belger, PhD

(919)-260-9822‬aysenil.belger@unc.edu

Locations

The University of North Carolina at Chapel Hill School of Medicine

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Aysenil Belger, PhD

aysenil.belger@unc.edu

Principal Investigator:

Aysenil Belger, PhD

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Nov 3, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.