RECRUITING

Adverse Adolescent Pathways to Substance Use

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Conditions

AnxietyAdolescent DevelopmentSubstance Use

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Adverse Adolescent Pathways to Substance Use

Quick Facts

Study Start:2024-02-20
Study Completion:2030-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06977178

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 14 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Male or female
  2. * 12-14 years old,
  3. * Report symptoms of anxiety
  4. * Understand and sign an assent, and parents will sign a permission and a consent document in English
  5. * Meets study hearing and vision requirements
  6. * Substance use naïve
  1. * 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.)
  2. * Has been diagnosed with psychosis or a severe emotional disturbance.
  3. * Has used alcohol, tobacco, or marijuana more than 3 times.
  4. * Is pregnant. Girls who self-report pregnancy may not participate in the stress evaluation or the MRI scan.
  5. * Is taking any medications that directly alter cardiovascular function (e.g., propranolol or other beta blockers).
  6. * Any current or lifetime treatment with antipsychotic medication.
  7. * Has had a head injury that resulted in a loss of consciousness for more than 5 minutes.
  8. * Is planning to get non-removable metal braces.
  9. * Impaired intellectual functioning (full-scale intelligence quotient \<70).
  10. * Past or current history of a clinically significant central nervous system that could confound brain imaging evaluations.

Contacts and Locations

Study Contact

Aysenil Belger, PhD
CONTACT
(919)-260-9822‬
aysenil.belger@unc.edu

Principal Investigator

Aysenil Belger, PhD
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

The University of North Carolina at Chapel Hill School of Medicine
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Aysenil Belger, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-20
Study Completion Date2030-06-30

Study Record Updates

Study Start Date2024-02-20
Study Completion Date2030-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Anxiety
  • Adolescent Development
  • Substance Use