FOCUS Bipolar: Families Opening Conversations for Understanding Signs
United States200 participantsStarted 2026-03-11
Plain-language 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.
Who can participate
Age range
7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Study participation: Able to comply with study procedures (e.g., co-design sessions, interviews, assessments).
. Language: Able to read, speak, and understand English.
. Age: 18 years or older.
. Caregiver status: The adult primarily responsible for the daily care and/or medical decisions for ≥ 6 months for a child aged 7-21 years whose biological parent has a lifetime, clinician-confirmed diagnosis of Bipolar I or II disorder.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Decision Aid Acceptability Score
Timeframe: 16 Months
2
Decision Aid Usability Score
Timeframe: 16 Months
3
Youth Screening Uptake Rate
Timeframe: 16 Months
4
Youth Screening Completion Rate
Timeframe: 16 Months
Trial details
NCT IDNCT07622927
SponsorUniversity of Texas Southwestern Medical Center
. Unable to provide informed consent due to cognitive impairment or language barriers
. Experiencing acute psychiatric instability at enrollment (e.g., acute psychosis or acute suicidality without stabilization)
. Has a medical or psychiatric condition that, in the judgment of the Principal Investigator or study clinician, would place undue risk on the individual or interfere with standard clinical care