Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07622927

FOCUS Bipolar: Families Opening Conversations for Understanding Signs

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

7 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2026-03-11

Completion Date

2027-07-31

Last Updated

2026-06-03

Healthy Volunteers

Yes

Interventions

OTHER

Co-design Workshop (Observational Procedure)

Participants in the workshop will help to co-design decision aid prototypes (short video and FAQ document) focused on early mental health screening for youth with one or more biological parents impacted by BD.

OTHER

Alpha Testing (Observational Procedure)

Participants will provide feedback on the initial version of the patient decision aid (short video and FAQ document).

OTHER

Beta Testing (Observational Procedure)

Participants will provide feedback on the refined version of the patient decision aid (short video and FAQ document).

OTHER

Youth Screening Pathway & Brief Follow-Up Interview (Observational Procedure)

Youth participants will take screening surveys for early bipolar risk detection.

Locations (1)

UT Southwestern Medical Center

Dallas, Texas, United States