๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-27

FOCUS Bipolar: Families Opening Conversations for Understanding Signs (NCT07622927)

A Data-Driven Approach to Early Mental Health Screening in Offspring of Parents With Bipolar Disorder

๐ŸŸข Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: University of Texas Southwestern Medical Center

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

Bipolar disorder often runs in families, but early symptoms in youth can go unrecognized for years. This project evaluates a structured, family-centered approach to informed screening for youth ages 7-21 who have a biological parent with bipolar disorder. The main questions addressed by this project are: Whether a co-designed video decision aid improves caregiver understanding of bipolar disorder genetic risk and supports informed decisions about youth screening. Whether remote mental health screening tools are feasible and acceptable for youth with familial risk for bipolar disorder. Whether screening results can be used to identify early risk patterns and inform tailored follow-up recommendations. Participants may be involved in one or more study activities, including co-design of educational decision-aid content, feedback on decision-aid prototypes, beta testing of the decision aid, and remote youth mental health screening. The study does not assign treatment and does not change existing clinical care or clinic routines.

Who can join: Review the eligibility criteria below.

Location: UT Southwestern Medical Center โ€” Dallas, Texas

Age range: 7 Years

๐Ÿงช Interventions in This Study

  • Co-design Workshop (Observational Procedure) (OTHER)
  • Alpha Testing (Observational Procedure) (OTHER)
  • Beta Testing (Observational Procedure) (OTHER)
  • Youth Screening Pathway & Brief Follow-Up Interview (Observational Procedure) (OTHER)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • UT Southwestern Medical Center โ€” Dallas, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (214) 648-4490

Email: FOCUSBipolar@UTSouthwestern.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—