FOCUS Bipolar: Families Opening Conversations for Understanding Signs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational effort aims to co-design and pilot a decision-aid and remote screening pathway for youth aged 7-21 with a biological parent diagnosed with bipolar disorder. It includes workshops to develop educational content, alpha and beta testing of the decision aid, and a remote youth screening process with brief follow-up interviews. The study focuses on feasibility, acceptability, and the practicality of using screening results to guide tailored follow-up recommendations. No treatment is assigned, and participation involves informational and evaluative activities rather than therapeutic interventions.

Why it matters

Who can join: the full rules

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 and willingness to consent: Able and willing to provide informed consent.
4. Study participation: Able to comply with study procedures (e.g., co-design sessions, interviews, assessments).
5. Language: Able to read, speak, and understand English.

Inclusion Criteria for Group C - At-Risk Youth:

1. Age:

   1. Phase 1 (co-design) and Phase 2A (alpha testing): 13-18 years
   2. Phase 2B (beta testing): 13-18 years
   3. Phase 3 (screening): 7-21 years
2. Diagnosis status: Must not have a current diagnosis of Bipolar I or II disorder.
3. 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).
4. Consent/Assent:

   1. For youth aged 18-21: Able and willing to provide informed consent (verbal)
   2. For youth aged 7-21: Parent/guardian/LAR able and willing to provide informed consent (verbal) and youth able to provide assent (verbal)
5. Participant ability: Able and willing to participate in study activities (e.g., co-design discussions, questionnaires, or screening assessments.
6. 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:

1. Unable to provide informed consent due to cognitive impairment or language barriers
2. Experiencing acute psychiatric instability at enrollment (e.g., acute psychosis or acute suicidality without stabilization)
3. 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's running

• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Karabi Nandy, PhD — University of Texas Southwestern Medical Center
• Study coordinator: Karabi Nandy, Ph.D.
• Email: FOCUSBipolar@UTSouthwestern.edu
• Phone: 214-648-4490

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.