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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH136102 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This project will examine how multiple biological measures from the brain and the body's stress response system contribute to anhedonia (the loss of pleasure) in adolescence. The goal of this project is to see if it is possible to combine these biological measures to describe different patterns of activity in the brain and body that adolescents may have in response to stress.
The main question this study aims to answer is whether different patterns of activity in the brain and body are related to whether adolescents develop anhedonia and how high or low levels of anhedonia are over time.
This study will enroll 192 adolescents who are between 13 and 15 years. Adolescents will complete tasks three times: at the beginning of the study, 10 months after that, and then 10 months after that. In total, they will be part of the study for 20 months. At each time, adolescents will complete surveys, provide samples of spit to measure hormones and provide pictures of their brain to measure brain activity, participate in mildly stressful tasks, and complete different activities that measure how they think. The investigators will also ask each adolescent's parent or legal guardian to answer some surveys about themselves and their child.
Participants will complete tasks at 3 timepoints (Baseline, 10-Months, and 20-Months). Some tasks will be in-person, while others will be virtual.
The assessments being administered at all three timepoints are:
Additionally, the following will be administered at each respective timepoint:
Baseline Assessment (Month 0):
Self-Report, Remote Questionnaires: demographic survey, address history survey, Protocol for Responding to & Assessing Patients' Assets, Risks & Experiences (PRAPARE), Pediatric Adverse Childhood Experiences and Related Life-events Screener (PEARLS) Cognitive (researcher administered, conducted in-person: Wechsler Abbreviated Scale of Intelligence Second Version (WASI-II) Psychological interview: Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS)
Time 2 (10-Months) Juvenile Victimization Questionnaire (JVQ) (self-report, completed remotely)
Time 3 (20-Months) Psychological interview: Abbreviated Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adolescent Teenagers | Experimental | Participants aged 13-15 (approximately Tanner pubertal stage 2-4) at study entry. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montreal Imaging Stress Task | Behavioral | Psychosocial stress procedure consisting of completing sections of mental arithmetic that are 5.5 minutes in length, during which the individual receives neutral and negative evaluative feedback about their performance relative to their peers. |
| Measure | Description | Time Frame |
|---|---|---|
| Anhedonia as assessed by the SHAPS | The Snaith-Hamilton Pleasure Scale (SHAPS) is a 14-item measure used to assess anhedonia. Each item has four answer responses: "strongly agree" (1 point), "agree" (2 points), "disagree" (3 points), and "strongly disagree" (4 points). The sum of these responses is taken to find the total score, which ranges from 0-56 with higher scores indicating more overall anhedonia. | Baseline, 10-months, 20-months |
| Percent signal change during the MIST | During the MIST, research participants complete mental arithmetic with the intermittent reception of neutral and negative evaluative feedback. The percent signal change of the fronto-limbic region of the brain will be analyzed during the MIST task. Higher percent signal change in these regions would indicate higher levels of activation when stressed. Percent signal change ranges between 1% to 5%. | Baseline, 10-Months, 20-Months |
| Endocrine (cortisol) response during the 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 is used to elicit physiological stress responses. The combination of stressors offers high levels of social-evaluative threat. Cortisol is collected through a saliva sample of passive drool a total of 5 times throughout the visit at 15-minute intervals. The higher the cortisol is found to be, the higher the stress response to the task. | Baseline, 10-Months, 20-Months |
| Endocrine (cortisol) response during the MIST | During the MIST, research participants complete mental arithmetic with the intermittent reception of neutral and negative evaluative feedback. Cortisol is collected through a saliva sample collected via cotton swab a total of 6 times throughout the visit at 15-minute intervals. The higher the cortisol is found to be, the higher the stress response to the task. | Baseline, 10-Months, 20-Months |
| Measure | Description | Time Frame |
|---|---|---|
| Anhedonia as assessed by the ACIPS | The Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS) assesses the ability to experience social pleasure. It contains 17-items scored on a 6-point Likert scale ranging from "very false for me" (1) to "very true for me" (6). The sum of these responses is taken to find the total score, which ranges from 17-102 with higher scores indicating lower capacity to experience or anticipate social pleasure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | Contact | (919) 351-5201 | staars@unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Aysenil Belger, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Danielle Roubinov, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
In accordance with National Institute of Mental Health (NIMH) policy, all individual-level data will be shared through the NIMH National Data Archive (NDA).
The data will be available to the public after the conclusion of the study and the publication of the manuscripts.
Access to the data is limited to individuals who meet the following data access eligibility criteria as described on the NIMH NDA website:
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| ID | Term |
|---|---|
| D059445 | Anhedonia |
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D011581 | Psychological Tests |
| ID | Term |
|---|---|
| D004191 | Behavioral Disciplines and Activities |
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| Trier Social Stress Test for Children | Behavioral | Psychosocial stress procedure in which the individual tells a story for 5 minutes in front of two neutral judges and performs mental arithmetic in front of the judges for 5 minutes. |
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| 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 is used to elicit physiological stress responses. The combination of stressors offers high levels of social-evaluative threat. Throughout the task, heart rate is measured to determine baseline resting state and HRV. HRV is the difference in the milliseconds between each heartbeat. 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. | Baseline, 10-Months, 20-Months |
| Baseline, 10-months, 20-months |
| Anhedonia as assessed by the TEPS | The Temporal Experience of Pleasure Scale (TEPS) is an 18-item measure used to assess anhedonia. It is scored on a 6-point Likert scale ranging from "very false for me" (1) to "very true for me" (6). The sum of these responses is taken to find the total score, which ranges from 18-108 with higher scores indicating more overall anhedonia. | Baseline, 10-months, 20-months |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |