Actively Recruiting
A Data-Driven Approach to Early Mental Health Screening in Offspring of Parents With Bipolar Disorder
Led by University of Texas Southwestern Medical Center · Updated on 2026-06-03
200
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
T
The Texas Child Mental Health Care Consortium (TCMHCC)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a family-centered approach to early mental health screening for youth aged 7 to 21 who have a biological parent diagnosed with bipolar disorder. This study aims to develop and test a video decision aid to help caregivers understand genetic risks and make informed screening decisions. It also assesses whether remote screening tools are feasible and acceptable and whether screening results can guide personalized follow-up care. Participants may take part in various activities, including co-designing the educational decision aid, providing feedback on prototypes, beta testing the decision aid, and completing remote mental health screenings. The screening combines fixed prodromal symptom items with computerized adaptive tests to identify early risk patterns. The study does not assign treatments or alter existing clinical care. During the study, participants provide input through workshops and interviews, complete questionnaires, and for youth, take screening surveys to detect early signs of bipolar disorder risk. Researchers will measure caregiver understanding and decision aid usability, youth screening uptake and completion rates, and feedback from both youth and caregivers. The study also monitors safety flags and risk categories, aiming to establish a scalable model for early psychiatric risk detection in youth with familial bipolar disorder history.
CONDITIONS
Brief Title
FOCUS Bipolar: Families Opening Conversations for Understanding Signs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older who have a lifetime diagnosis of Bipolar I or II and have at least one biological child aged 7-21 years
- Adults aged 18 years or older who are primary caregivers responsible for a child aged 7-21 with a biological parent diagnosed with Bipolar I or II
- Youth aged 7-21 years without bipolar disorder who have at least one biological parent with a lifetime diagnosis of Bipolar I or II
- Ability and willingness to provide informed consent or assent as appropriate
- Ability to comply with study procedures such as co-design sessions, interviews, assessments
- Ability to read, speak, and understand English
You will not qualify if you...
- Unable to provide informed consent due to cognitive impairment or language barriers
- Experiencing acute psychiatric instability at enrollment, such as acute psychosis or acute suicidality without stabilization
- Medical or psychiatric conditions that pose undue risk or interfere with standard clinical care as judged by the study clinicians
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Up to 16 months
Participants engage in workshops and provide feedback to help co-design and refine a decision aid for early mental health screening.
Multiple sessions depending on participant role
Duration - Up to 16 months
Youth participants complete screening surveys for early bipolar risk detection followed by a brief follow-up interview to discuss results and next steps.
1 to 2 visits depending on screening results
Trial Site Locations
Total: 1 location
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
K
Karabi Nandy, Ph.D.
K
Karabi Nandy, Ph.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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