FOCUS Bipolar: Families Opening Conversations for Understanding Signs
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-d
| Condition(s) | Bipolar Disorder (BD), Bipolar Disorder I or II, Bipolar Disorder Family Members, Screening Tool |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 educat |
| Who can participate | Inclusion Criteria for Group A - Parent with Bipolar Disorder: 1. Age: 18 years or older. 2. Confirmation of a lifetime Bipolar I or II diagnosis 3. Parent status: Has at least one biological child aged 7-21 years. 4. Capacity and willingness to consent: Able and willing to provide informed consent. 5. Study participation: Able to comply with study procedures (e.g., co-design sessions, interviews, assessments). 6. Language: Able to read, speak, and understand English. Inclusion Criteria for Group B - Adult Caregiver: 1. Age: 18 years or older. 2. 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. 3. Capacity |
| Ages | 7 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University of Texas Southwestern Medical Center |
| Locations | Dallas, Texas, United States |
| Start date | 2026-03-11 |
| NCT ID | NCT07622927 |
| Official listing | https://clinicaltrials.gov/study/NCT07622927 |