FOCUS Bipolar: Understanding Bipolar Disorder Risk in Families

This study, called FOCUS Bipolar, is looking at ways to help families understand the risk of bipolar disorder (a mental health condition causing extreme mood swings) in children and teenagers. It's an observational study, meaning researchers will watch and learn, not give new treatments. They are testing a family-centered approach to screening youth aged 7-21 who have a biological parent with bipolar disorder. The study will involve creating and testing a video and FAQ document to help parents make informed decisions about screening. Researchers want to see if these tools help parents understand genetic risk and if remote screening for youth is practical and accepted. They also want to identify early risk patterns. About 200 people are expected to join. The study is currently unclear on its recruitment status.

Study design
This is an observational study involving approximately 200 participants. It includes co-design workshops and testing of decision aid prototypes.
What's involved
You might participate in workshops to help design educational materials, or provide feedback on video and FAQ documents. Youth participants will take screening surveys.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes like decision aid acceptability and usability, and youth screening uptake rate, at 16 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07622927

FOCUS Bipolar: Families Opening Conversations for Understanding Signs

Recruiting
Not specifiedAges 7+Observational
University of Texas Southwestern Medical Center
~200 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:Co-design Workshop (Observational Procedure)Alpha Testing (Observational Procedure)Beta Testing (Observational Procedure)Youth Screening Pathway & Brief Follow-Up Interview (Observational Procedure)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Decision Aid Acceptability Score
Measured over 16 Months
+3 more outcomes measured
Bipolar Disorder (BD)
Bipolar Disorder I or II
Bipolar Disorder Family Members
Screening Tool
1 sites across 1 states
Texas1
  • Karabi Nandy, PhD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

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  • Decision Aid Acceptability Score16 Months

    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.

  • Decision Aid Usability Score16 Months

    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.

  • Youth Screening Uptake Rate16 Months

    Percentage of eligible caregivers who consent for youth mental health screening after participation in the decision-aid workflow.

  • Youth Screening Completion Rate16 Months

    Percentage of youth participants who complete the assigned remote mental health screening battery after consent or permission and assent, as applicable.