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Active Not Recruiting
NCT03458936
Resilience in Adolescent Development
Conditions: Risk Assessment, Resilience, Psychological, Depression, Mood Disorders, Anxiety Disorders, Mental Health
Sex: All
Ages: 10 Years – 24 Years
Healthy volunteers: Yes
Enrollment: 1500
Sponsor: University of Texas Southwestern Medical Center
Location: UT Southwestern Medical Center Dallas Texas
Summary
RAD is a 10-year natural history, longitudinal, prospective assessment study of a cohort of 2,500 participants (ages 10-24 years) that will help uncover the socio-demographic, lifestyle, clinical, psychological, and neurobiological factors that contribute to resilience among children, adolescents, and young adults at-risk for mood and anxiety disorders. As this is an exploratory study, we will assess a comprehensive panel of carefully selected participant specific parameters, including socio-demographic, life habits, clinical, biological, behavioral, neurophysiological, and neuroimaging. The study is designed to observe and collect factors associated with resilience in a non-invasive fashion; no interventions or treatments will be conducted during the project. Assessments will be conducted up to 4 times per year for up to 10 years, as well as a baseline visit. Study visits will be conducted in person whenever feasible but may be completed by phone/mail/computer, if an in-person visit is not possible.
Eligibility Criteria
Inclusion Criteria:
1. Youth aged 10-24, male and female of all races and ethnicity.
2. Able to speak, read, and understand English. However, the parent(s)/guardian(s)/legally authorized representatives (LAR) may either speak English or Spanish as the consenting process can be conducted bilingually.
3. Adults aged 18 and older must be able to provide written informed consent; for youth younger than age 18, parent(s)/guardian(s)/LAR must provide written informed consent, and the youth must provide written informed assent.
4. Ability to complete clinical evaluations and neuropsychological testing.
5. Belong to one of the following groups:
1. Individual at risk for a Mood Disorder: defined as either: a) Personal history (anxiety disorder, conduct disorder, substance use disorder, etc.) of a mental health disorder that is a not a mood disorder, OR b) No current or past mood disorder, but individual with Biological Family history (ex. mother, father, siblings, uncles, aunts, etc.) of mood disorder, substance use disorder, suicide deaths or attempts, or other mental health disorder.
2. Healthy Individual: defined as having no psychiatric diagnoses (no history of mood disorders and having no relative with a history of a mood disorder).
Exclusion Criteria:
1. Individuals who are unable to provide informed consent or assent.
2. Participants who are non-English speaking.
3. Individuals with any of the following psychotic features: Mood Disorder with psychotic features, schizophrenia, schizoaffective disorder, or other psychotic disorder.
4. (participants who develop depression during the longitudinal follow-up will continue in the study).
5. A PHQ-9 score of 10 or greater.
6. Individuals who are unable to provide a stable home address and contact information.
7. Has any condition for which, in the opinion of the investigator or designee, study participation would not be in their best interest (including but not limited to cognitive impairment, unstable general medical condition, intoxication, active psychosis) or that could prevent, limit, or confound the protocol-specified assessments.
Exclusion for Healthy Controls
1. A lifetime or a current history of a mood disorder based upon a semi-structured diagnostic interview.
2. Personal (anxiety disorder, conduct disorder, substance use disorder, etc.) history of a mental health disorder that is not a mood disorder, or Biological Family (ex. mother, father, siblings, uncles, aunts, etc.) with history of mood disorder, substance use disorder, suicide deaths or attempts or other mental health disorder. (May participate in the RAD study as a non-healthy control).
3. Meets any exclusion criteria as part of the main RAD study.
Source: ClinicalTrials.gov (NCT03458936). StuddyBuddy aggregates publicly available trial information.