FOCUS Bipolar: Families Opening Conversations for Understanding Signs

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7+
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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 criteria

Qualifiers

Age: 18 years or older.

Confirmation of a lifetime Bipolar I or II diagnosis

Parent status: Has at least one biological child aged 7-21 years.

Capacity and willingness to consent: Able and willing to provide informed consent.

Disqualifiers

None

Trial design

Treatments tested in this trial

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

Treatment groups

200 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of Texas Southwestern Medical Center

Lead sponsor

The Texas Child Mental Health Care Consortium (TCMHCC)

Collaborator