FOCUS Bipolar: Families Opening Conversations for Understanding Signs

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.

Conditions

• Bipolar Disorder (BD)
• Bipolar Disorder I or II
• Bipolar Disorder Family Members
• Screening Tool

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.

Sponsors & Collaborators

• The Texas Child Mental Health Care Consortium (TCMHCC)

  collaborator UNKNOWN

• University of Texas Southwestern Medical Center

  lead OTHER

Principal Investigators

• Karabi Nandy, PhD · University of Texas Southwestern Medical Center

Eligibility

Min Age

7 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-03-11

Primary Completion

2027-06-30

Completion

2027-07-31

Countries

• United States

Study Locations