FOCUS Bipolar: Families Opening Conversations for Understanding Signs
FOCUS Bipolar
A Data-Driven Approach to Early Mental Health Screening in Offspring of Parents With Bipolar Disorder
1 other identifier
observational
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2026
CompletedStudy Start
First participant enrolled
March 11, 2026
CompletedFirst Posted
Study publicly available on registry
June 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
June 3, 2026
May 1, 2026
1.3 years
February 21, 2026
May 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Decision Aid Acceptability Score
Mean participant rating of decision aid acceptability using study-specific Likert-type items assessing clarity, balance, trustworthiness, and usefulness. Items are rated from 1 to 5, with 1 indicating strongly disagree and 5 indicating strongly agree. Higher scores indicate greater acceptability.
16 Months
Decision Aid Usability Score
Description: Mean participant rating of decision aid usability using study-specific Likert-type items assessing ease of navigation, visual clarity, and overall satisfaction. Items are rated from 1 to 5, with 1 indicating strongly disagree and 5 indicating strongly agree. Higher scores indicate greater usability.
16 Months
Youth Screening Uptake Rate
Percentage of eligible caregivers who consent for youth mental health screening after participation in the decision-aid workflow.
16 Months
Youth Screening Completion Rate
Percentage of youth participants who complete the assigned remote mental health screening battery after consent or permission and assent, as applicable.
16 Months
Secondary Outcomes (4)
Time to Complete Youth Screening
16 Months
Youth and Caregiver Post-Screening Feedback Score
16 Months
Safety Flag Rate
16 Months
Risk Stratification Category Distribution
16 Months
Study Arms (3)
Group A - Parent with Bipolar Disorder
Parents (age 18 or older) who have ever been diagnosed with bipolar disorder and have a biological child between the ages of 7-21
Group B - Adult Caregiver
Caregivers (age 18 or older) who are primarily responsible for a child between the ages of 7-21 whose biological parent has a lifetime diagnosis of bipolar disorder
Group C - At-Risk Youth
Youth (ages 7-21) without bipolar disorder, but has at least 1 biological parent with a lifetime diagnosis of bipolar disorder
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.
Eligibility Criteria
The following groups are being targeted for this observational study: 1. Parents (age 18 or older) who have ever been diagnosed with bipolar disorder and have a biological child between the ages of 7-21 2. Caregivers (age 18 or older) who are primarily responsible for a child between the ages of 7-21 whose biological parent has a lifetime diagnosis of bipolar disorder 3. Youth (ages 7-21) without bipolar disorder, but has at least 1 biological parent with a lifetime diagnosis of bipolar disorder
You may qualify if:
- 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
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karabi Nandy, PhD
University of Texas Southwestern Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- FAMILY BASED
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Biostatistics & Psychiatry
Study Record Dates
First Submitted
February 21, 2026
First Posted
June 3, 2026
Study Start
March 11, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
June 3, 2026
Record last verified: 2026-05