Risk AssessmentRADNCT03458936
Resilience in Adolescent Development
An observational study of Risk Assessment and Resilience, Psychological, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Assessment, Resilience, Psychological, Depression
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2016to Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants will be males or females between ages 10 and 24 who have provided informed consent.
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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).
- Meets any exclusion criteria as part of the main RAD study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Keywords
- Depression, Adolescence, Resilience, Risk Factor, Biomarker
- Medical subject headings
- Depression, Mood Disorders, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 Years
Secondary outcomes (7)
Functioning (MRI)
Comparison of Longitudinal changes in functioning as measured by Magnetic Resonance Imaging (MRI) in participants without a mood disorder.
Measured: 10 Years
Functioning (EEG)
Comparison of Longitudinal changes in functioning as measured by quantitative electroencephalography (EEG) in participants without a mood disorder.
Measured: 10 Years
Biomarkers (Proteomic Methods)
Comparison of longitudinal changes in fluid-based biomarkers as measured by proteomic methods in participants without a mood disorder.
Measured: 10 Years
Biomarkers (Metabolomics Methods)
Comparison of longitudinal changes in fluid-based biomarkers as measured by metabolomics methods in participants without a mood disorder.
Measured: 10 Years
Biomarkers (Transcriptomic Methods)
Comparison of longitudinal changes in fluid-based biomarkers as measured by transcriptomic methods in participants without a mood disorder.
Measured: 10 Years
Biomarkers (Genomic Methods)
Comparison of longitudinal changes in fluid-based biomarkers as measured by genomic methods in participants without a mood disorder.
Measured: 10 Years
Biomarkers (Epigenomic Methods)
Comparison of longitudinal changes in fluid-based biomarkers as measured by epigenomic methods in participants without a mood disorder.
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start17 Aug 2016
- Primary completionDec 2031 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center
- Investigators
- Madhukar H. Trivedi, MD, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458936
- Sponsor's protocol ID
- STU 062016-042
- Acronym
- RAD
- Status last verified
- Sep 2026
- First submitted
- 5 Apr 2017
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience in Adolescent Development
- ClinicalTrials.gov ID
- NCT03458936
- Acronym / sponsor ID
- RAD / STU 062016-042
- Conditions
- Risk Assessment, Resilience, Psychological, Depression, Mood Disorders, Anxiety Disorders, Mental Health
- Keywords
- Depression, Adolescence, Resilience, Risk Factor, Biomarker
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 17 Aug 2016 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 8 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 10 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants will be males or females between ages 10 and 24 who have provided informed consent.
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Depression Severity
Time frame: 10 Years
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
7 secondary outcomes
Functioning (MRI)
Time frame: 10 Years
Functioning (EEG)
Time frame: 10 Years
Biomarkers (Proteomic Methods)
Time frame: 10 Years
Biomarkers (Metabolomics Methods)
Time frame: 10 Years
Biomarkers (Transcriptomic Methods)
Time frame: 10 Years
Biomarkers (Genomic Methods)
Time frame: 10 Years
Biomarkers (Epigenomic Methods)
Time frame: 10 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Risk Assessment
Not yet recruitingObservational study
Assessing the Incidence of Transplant Associated Thrombotic Microangiopathy (TA-TMA) in Adult Patients Undergoing Allogeneic Stem Cell Transplant (SCT)
Transplant Associated Microangiopathy TAM, Transplant Complication
RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
Recruiting
Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)
Cardiovascular Diseases (CVD), Metabolic Syndrome
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Recruiting
Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhukar H. Trivedi, MD principal investigator
UT Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Risk Assessment and Resilience, Psychological, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Severity (time frame: 10 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.