Adverse Adolescent Pathways to Substance Use
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-14
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Trier Social Stress Test
BehavioralPsychosocial stress procedure; 5 minutes of public speaking (preceded by 5 minutes of preparation) and 5 minutes of mental arithmetic.
Treatment groups
180 Participants
are divided into 1 treatment groupGroup A: Trier Social Stress Test (TSST)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline, 12-months, 24-months2
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%.
Time frame
baseline, 12-months, 24-months3
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%.
Time frame
baseline, 12-months, 24-months4
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%.
Time frame
baseline, 12-months, 24-monthsSecondary outcomes
1
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.
Time frame
at baseline, 12-month and 24-month2
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.
Time frame
at baseline, 12-month and 24-monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
RTI International
Collaborator
Source ClinicalTrials.gov