FOCUS Bipolar: Families Opening Conversations for Understanding Signs
A Data-Driven Approach to Early Mental Health Screening in Offspring of Parents With Bipolar Disorder
University of Texas Southwestern Medical Center
200 participants
Mar 11, 2026
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
Inclusion Criteria27
- 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.
- 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:
- Phase 1 (co-design) and Phase 2A (alpha testing): 13-18 years
- Phase 2B (beta testing): 13-18 years
- Phase 3 (screening): 7-21 years
- Diagnosis status: Must not have a current diagnosis of Bipolar I or II disorder.
- Parental diagnosis: Has at least 1 biological parent with a lifetime, clinician-confirmed Bipolar I or II diagnosis (as defined in Groups A and B).
- Consent/Assent:
- For youth aged 18-21: Able and willing to provide informed consent (verbal)
- For youth aged 7-21: Parent/guardian/LAR able and willing to provide informed consent (verbal) and youth able to provide assent (verbal)
- Participant ability: Able and willing to participate in study activities (e.g., co-design discussions, questionnaires, or screening assessments.
- Language: English sufficient to comprehend study procedures and materials.
- Criteria for Exclusion of Participants
- A potential participant will NOT be eligible for participation in this study if any of the following criteria are met:
- 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
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Interventions
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.
Participants will provide feedback on the initial version of the patient decision aid (short video and FAQ document).
Participants will provide feedback on the refined version of the patient decision aid (short video and FAQ document).
Youth participants will take screening surveys for early bipolar risk detection.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07622927