Clinical Trial

FOCUS Bipolar: Families Opening Conversations for Understanding Signs

Study acronym: FOCUS Bipolar
Recruiting
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Summary
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.
Trial Details
NCT Number NCT07622927
Lead Sponsor University of Texas Southwestern Medical Center
Collaborators: The Texas Child Mental Health Care Consortium (TCMHCC)
Conditions Bipolar Disorder (BD), Bipolar Disorder I or II, Bipolar Disorder Family Members, Screening Tool
Enrollment 200 participants
Start Date 2026-03-11
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-03