Understanding resilience in adolescents and young adults at risk for mood disorders

Resilience in Adolescent Development

This study is looking at how young people aged 10-24 can build resilience against mood and anxiety disorders by tracking their mental health and various life factors over ten years.

Quick facts

• Study type: Observational
• Enrollment: 1500 (estimated)
• Ages: 10 Years to 24 Years
• Sex: All
• Sponsor: University of Texas Southwestern Medical Center (other)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT03458936 on ClinicalTrials.gov

What this trial studies

This observational study follows a cohort of 2,500 participants aged 10-24 over a 10-year period to explore the factors contributing to resilience against mood and anxiety disorders. It aims to identify and validate biosignatures of resilience by assessing a wide range of socio-demographic, lifestyle, clinical, psychological, and neurobiological factors. Participants will undergo assessments up to four times a year, including questionnaires and neuroimaging, to track changes in their mental health and resilience. The study is non-invasive and does not involve any treatments or interventions.

Who should consider this trial

Good fit: Ideal candidates are youth aged 10-24 who are at risk for mood disorders due to personal or family history.

Not a fit: Patients who do not fall within the specified age range or do not have a relevant risk factor for mood disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and prevention strategies for mood and anxiety disorders in at-risk youth.

How similar studies have performed: While the approach of identifying biosignatures of resilience is innovative, similar studies have shown promise in understanding mental health risk factors.

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.

Where this trial is running

Dallas, Texas

• UT Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Madhukar H. Trivedi, MD — UT Southwestern
• Study coordinator: Afrida Khurshid, BA

Conditions: Risk Assessment, Resilience, Psychological, Depression, Mood Disorders, Anxiety Disorders, Mental Health, Adolescence, Resilience