ClinicalTrials.gg
Active, not recruitingNCT03458936RADUpdated Sep 15, 2026

Resilience in Adolescent Development

An observational study in Risk Assessment, Resilience, Psychological and Depression, sponsored by University of Texas Southwestern Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 10 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by University of Texas Southwestern Medical Center · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
10 Years to 24 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 47 studies in Depression by University of Texas Southwestern Medical Center — 6 open to participants now, 9 under way, none of them phase 3. Depression · University of Texas Southwestern Medical Center.

Planned enrollment
4th of 10
1,500 · median 744
Started
2016
with 4 others
Observational
10 of 47
2 open now
Registered
26th of 47
by date

Among the 47 studies in Depression by University of Texas Southwestern Medical Center, this one is the 4th largest by planned enrollment of the 10 observational ones that give a count, is one of 5 that started in 2016, is one of 10 observational ones, and was the 26th registered.

Depression

8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.

Browse Depression studies →

Open to participants now

6 of the 47 studies in Depression by University of Texas Southwestern Medical Center are open now, in 1 country. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.

This study: 10 Years to 24 Years · all sexes · healthy volunteers too.

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02

Study 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.

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.

03

Conditions studied

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

Keywords

  • Depression
  • Adolescence
  • Resilience
  • Risk Factor
  • Biomarker
04

Who can participate

Ages eligible
10 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

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 ; 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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).

06

What researchers measure

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

    Time frame: 10 Years

Secondary outcomes

  1. Functioning (MRI)

    Comparison of Longitudinal changes in functioning as measured by Magnetic Resonance Imaging (MRI) in participants without a mood disorder.

    Time frame: 10 Years

  2. Functioning (EEG)

    Comparison of Longitudinal changes in functioning as measured by quantitative electroencephalography (EEG) in participants without a mood disorder.

    Time frame: 10 Years

  3. Biomarkers (Proteomic Methods)

    Comparison of longitudinal changes in fluid-based biomarkers as measured by proteomic methods in participants without a mood disorder.

    Time frame: 10 Years

  4. Biomarkers (Metabolomics Methods)

    Comparison of longitudinal changes in fluid-based biomarkers as measured by metabolomics methods in participants without a mood disorder.

    Time frame: 10 Years

  5. Biomarkers (Transcriptomic Methods)

    Comparison of longitudinal changes in fluid-based biomarkers as measured by transcriptomic methods in participants without a mood disorder.

    Time frame: 10 Years

  6. Biomarkers (Genomic Methods)

    Comparison of longitudinal changes in fluid-based biomarkers as measured by genomic methods in participants without a mood disorder.

    Time frame: 10 Years

  7. Biomarkers (Epigenomic Methods)

    Comparison of longitudinal changes in fluid-based biomarkers as measured by epigenomic methods in participants without a mood disorder.

    Time frame: 10 Years

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2016 (actual). Primary completion is estimated for Dec 2031, 184 months after the start.

Of 460 non-industry observational studies under Depression, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 63. This study's planned 184 months is above that.

Counting every sponsor, half of 493 studies reached it within 32 months; a quarter within 13 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 5, 2017
First posted
Mar 8, 2018
StartActual
Aug 17, 2016
Primary completionEst.
Dec 2031
CompletionEst.
Dec 2032
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03458936
Responsible party
Madhukar H. Trivedi, MD (Professor of Psychiatry, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Mar 8, 2018
Start date
Aug 17, 2016
Primary completion
Dec 2031 (estimated)
Completion
Dec 2032 (estimated)
Last update
Sep 15, 2026

Study contacts

Madhukar H. Trivedi, MD
principal investigator · UT Southwestern

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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