RecruitingNCT07622927

FOCUS Bipolar: Families Opening Conversations for Understanding Signs

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


Sponsor

University of Texas Southwestern Medical Center

Enrollment

200 participants

Start Date

Mar 11, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 7 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Alpha Testing (Observational Procedure), Beta Testing (Observational Procedure), and others for people with bipolar disorder (bd), bipolar disorder family members, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCo-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.

OTHERAlpha Testing (Observational Procedure)

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

OTHERBeta Testing (Observational Procedure)

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

OTHERYouth 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

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NCT07622927


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