FOCUS Bipolar: Families Opening Conversations for Understanding Signs
Recruiting · NCT07622927 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Texas Southwestern Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
Inclusion criteria
- for Group A - Parent with Bipolar Disorder:
- 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.
- Inclusion Criteria for Group B - Adult Caregiver:
- 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.
- Inclusion Criteria for Group C - At-Risk Youth:
- 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
Where it is running
1 location listed across 1 US state.
- UT Southwestern Medical Center - Dallas, Texas, United States