RECRUITING

Resilience in Adolescent Development

Talk to us

Conditions

Risk AssessmentResilience, PsychologicalDepressionMood DisordersAnxiety DisordersMental HealthAdolescenceResilienceRisk FactorBiomarker

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Resilience in Adolescent Development

Quick Facts

Study Start:2016-08-17
Study Completion:2032-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03458936

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 24 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Youth aged 10-24, male and female of all races and ethnicity.
  2. 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. 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. 4. Ability to complete clinical evaluations and neuropsychological testing.
  5. 5. Belong to one of the following groups:
  6. 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.
  7. 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).
  1. 1. Individuals who are unable to provide informed consent or assent.
  2. 2. Participants who are non-English speaking.
  3. 3. Individuals with any of the following psychotic features: Mood Disorder with psychotic features, schizophrenia, schizoaffective disorder, or other psychotic disorder.
  4. 4. (participants who develop depression during the longitudinal follow-up will continue in the study).
  5. 5. A PHQ-9 score of 10 or greater.
  6. 6. Individuals who are unable to provide a stable home address and contact information.
  7. 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.
  8. 1. A lifetime or a current history of a mood disorder based upon a semi-structured diagnostic interview.
  9. 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).
  10. 3. Meets any exclusion criteria as part of the main RAD study.

Contacts and Locations

Study Contact

Afrida Khurshid
CONTACT
214.998.5877
Afrida.Khurshid@UTSouthwestern.edu
Sangita Sethuram, MBA, CCRP
CONTACT
214-648-4357
TRAD@UTSouthwestern.edu

Principal Investigator

Madhukar H. Trivedi, MD
PRINCIPAL_INVESTIGATOR
UT Southwestern

Study Locations (Sites)

UT Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Madhukar H. Trivedi, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-08-17
Study Completion Date2032-12

Study Record Updates

Study Start Date2016-08-17
Study Completion Date2032-12

Terms related to this study

Keywords Provided by Researchers

  • Depression
  • Adolescence
  • Resilience
  • Risk Factor
  • Biomarker

Additional Relevant MeSH Terms

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