Resilience in Adolescent Development

NCT03458936 | Active Not Recruiting

• 1 other identifier: STU 062016-042
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Risk Assessment; Resilience, Psychological; Depression; Mood Disorders; Anxiety Disorders; Mental Health

Keywords

Depression; Adolescence; Resilience; Risk Factor; Biomarker

Outcome Measures

Primary Outcomes (1)

• Depression Severity

  Longitudinal changes in depression presence and severity of participants without a mood disorder on Patient Health Questionnaire (PHQ-9). Interpretation of Total Scores: 0-4: Minimal depression or no depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20-27: Severe depression

  10 Years

Secondary Outcomes (7)

• Functioning (MRI)

  10 Years

• Functioning (EEG)

  10 Years

• Biomarkers (Proteomic Methods)

  10 Years

• Biomarkers (Metabolomics Methods)

  10 Years

• Biomarkers (Transcriptomic Methods)

  10 Years

Study Arms (2)

Individual at risk for a Mood Disorder

Youth aged 10-24, male and female of all races and ethnicity with either: a) 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 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.

Healthy Individual

Youth aged 10-24, male and female of all races and ethnicity with no psychiatric diagnoses (no history of mood disorders and having no relative with a history of a mood disorder).

Eligibility Criteria

• Age: 10 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Participants will be males or females between ages 10 and 24 who have provided informed consent.

You may qualify if:

• Youth aged 10-24, male and female of all races and ethnicity.
• 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.
• 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.
• Ability to complete clinical evaluations and neuropsychological testing.
• Belong to one of the following groups:
• 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.
• Healthy Individual: defined as having no psychiatric diagnoses (no history of mood disorders and having no relative with a history of a mood disorder).

You may not qualify if:

• Individuals who are unable to provide informed consent or assent.
• Participants who are non-English speaking.
• Individuals with any of the following psychotic features: Mood Disorder with psychotic features, schizophrenia, schizoaffective disorder, or other psychotic disorder.
• (participants who develop depression during the longitudinal follow-up will continue in the study).
• A PHQ-9 score of 10 or greater.
• Individuals who are unable to provide a stable home address and contact information.
• 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.
• A lifetime or a current history of a mood disorder based upon a semi-structured diagnostic interview.
• 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).

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Urine, Saliva, Stool

MeSH Terms

Conditions

Depression; Mood Disorders; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Study Officials

• Madhukar H. Trivedi, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: March 8, 2018
• Study Start: August 17, 2016
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2032
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

US (1)