Resilience in Adolescent Development

NCT ID: NCT03458936

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-17
• Study Completion Date: 2032-12-31

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.

Detailed Description

The primary objective of this initiative is identify and validate biosignatures of resilience. Specifically, the research will identify protective factors (socio-demographic, lifestyle, clinical and behavioral assessments, fluid-based biomarkers, genomics, neuroimaging, EEG, and cell-based assays) that reduce risk of developing mood and anxiety disorders in adolescents and young adults at risk for these illnesses.

Presence and severity of symptoms will be assessed over 10 years using questionnaires for symptom changes, social factors, and overall quality of life. Other outcomes generated from this study will include rate of change in quantitative measures of brain function, of depression relevant brain regions correlated with systems-levels behavior and other functional neuro-circuitry MRI measures. Rate of change of specified biochemical biomarkers will also be assessed. Integration of these measures will provide an unmatched understanding into the mechanisms of resilience and protection against depression and anxiety disorders and holds tremendous promise for identifying targets for prevention strategies.

Specific Aims of the RAD Study:

Aim 1 - Examine baseline biosignatures and independent factors (demographic, social, environmental, genetic, EEG, and fMRI) associated with resilience in at-risk adolescents and young adults.

Aim 2 - Examine changes in the biomarker factors annually for 10 years to determine for plasticity of these biomarkers.

Aim 3 - Examine the interaction between psychiatric symptoms and changes in the biopsychosocial signature.

Aim 4 - Evaluate psychological, social, and physiological correlates, from mobile based data, of mood changes to construct a model of risk and resilience to depression and mood disorders among adolescents and young adults.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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).

No interventions assigned to this group

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).

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Madhukar H. Trivedi, MD

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Madhukar H. Trivedi, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Afrida Khurshid, BA

Role: CONTACT

TRAD@UTSouthwestern.edu

(214) 998 - 5877

Sangita Sethuram, MBA, CCRP

Role: CONTACT

TRAD@UTSouthwestern.edu

(214) 648 - 4357

Facility Contacts

Afrida Khurshid, BA

Role: primary

TRAD@UTSouthwestern.edu

214-998-5877

Sangita Sethuram, MBA, CCRP

Role: backup

TRAD@UTSouthwestern.edu

214-648-0157

Other Identifiers

STU 062016-042

Identifier Type: -

Identifier Source: org_study_id