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

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.

Study Overview

• Status: Recruiting
• Conditions: Bipolar Disorder Family Members; Bipolar Disorder (BD); Bipolar Disorder I or II; Screening Tool
• Intervention / Treatment: Other: Co-design Workshop (Observational Procedure); Other: Alpha Testing (Observational Procedure); Other: Beta Testing (Observational Procedure); Other: Youth Screening Pathway & Brief Follow-Up Interview (Observational Procedure)

Detailed Description

Background and Rationale:

Bipolar disorder (BD), characterized by acute mood fluctuations between manic and depressive states, affects approximately 5.7 million adults each year in the United States and is the fourth leading cause of disability among those aged 10-24 worldwide. BD is estimated to inflict an annual economic burden of $195 billion in the United States alone. Despite its high prevalence and significant impact on both disability and the economy, BD is typically diagnosed 11-17 years after symptom emergence. This results in delayed intervention, increased morbidity, and an elevated suicide risk.

While the etiology of BD is unknown, there is substantial evidence suggesting that it is associated with genetic, epigenetic, and neurochemical factors. Heritability is well established. A child who has a biological parent with BD is at a 15-30% risk of developing the disorder, and the risk increases to 50-75% when both parents are affected. This familial risk is widely recognized and presents a compelling opportunity for preventive measures, particularly during the prodromal phase, prior to the realization of full diagnostic criteria.

Purpose:

The purpose of this research is to develop and evaluate a stakeholder-informed, scalable screening approach in a pilot feasibility study for early identification of mental health risk in youth (ages 7-21) who have a biological parent with bipolar disorder (BD). Despite well-documented genetic risk, there is currently no established protocol to support family-initiated screening in this high-risk group.

Objectives:

1. Develop and refine a brief, co-designed video decision aid (DA) to support BD-affected adults or caregivers in making informed choices about screening their children.
2. Evaluate the decision aid's effectiveness in improving knowledge, reducing decisional conflict, and increasing willingness to screen among caregivers.
3. Conduct pilot mental health screenings of at-risk youth using a hybrid model combining fixed prodromal symptom items and the Computerized Adaptive Test for Mental Health (CAT-MH®) and Kiddie Computerized Adaptive Test for Mental Health (K-CAT-MH®) adaptive screeners.
4. Create and evaluate a structured follow-up framework that stratifies screening results by risk and links them to relevant next steps in care.

Hypothesis:

The hypothesis is that a family-centered, stakeholder-designed decision aid will encourage a significant portion of BD-affected adults or caregivers to consent to their children's screening and that adaptive screening will find youth with early symptom patterns that might benefit from further monitoring or risk-stratified follow-up. The goal is not to identify all at-risk youth, but rather to assess the feasibility, acceptability, and preliminary yield of this family-informed screening model.

This hypothesis is supported by evidence that early symptoms such as mood instability, anxiety, and behavioral dysregulation often precede the onset of full syndromal BD, particularly in youth with a biological parent diagnosed with BD. However, existing early identification models are largely clinician-driven, and families often lack tools to guide screening decisions. Decision aids, which are widely used in other areas of healthcare, have been shown to improve decision quality, reduce decisional conflict, and increase knowledge - particularly in situations involving uncertainty or personal values. There is strong evidence that decision-making informed by stakeholders enhances the relevance, uptake, and ethical alignment of initiatives, particularly when engaging families on sensitive or stigmatized clinical topics. Finally, recent research has shown that remote, adaptive mental health screening is feasible in high-risk youth populations. These results collectively substantiate the rationale for the piloting of a novel, family-centered approach that integrates stakeholder-informed decision assistance with adaptive screening and structured follow-up.

Overarching Study Goal:

The long-term goal of this work is to generate a scalable, evidence-based model for early detection of psychiatric risk in youth with a familial history of BD. By fostering informed caregiver engagement and incorporating risk-stratified follow-up recommendations, this project establishes the foundation for future practice guidelines that transition the field from reactive diagnosis to preventive mental health care. This approach is comparable to those employed in other heritable conditions, such as cancer and heart disease.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Karabi Nandy, Ph.D.; Phone Number: 214-648-4490; Email: FOCUSBipolar@UTSouthwestern.edu
• Study Contact Backup: Name: Karabi Nandy, Ph.D.; Phone Number: 214-648-9551; Email: FOCUSBipolar@UTSouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern Medical Center
      • Contact: Karabi Nandy, Ph.D.; Phone Number: 214-648-9551; Email: FOCUSBipolar@UTSouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Co-design Workshop (Observational Procedure); 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.; Other: Alpha Testing (Observational Procedure); Participants will provide feedback on the initial version of the patient decision aid (short video and FAQ document).; Other: Beta Testing (Observational Procedure); Participants will provide feedback on the refined version of the patient decision aid (short video and FAQ document).
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	Other: Co-design Workshop (Observational Procedure); 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.; Other: Alpha Testing (Observational Procedure); Participants will provide feedback on the initial version of the patient decision aid (short video and FAQ document).; Other: Beta Testing (Observational Procedure); Participants will provide feedback on the refined version of the patient decision aid (short video and FAQ document).
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	Other: Co-design Workshop (Observational Procedure); 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.; Other: Alpha Testing (Observational Procedure); Participants will provide feedback on the initial version of the patient decision aid (short video and FAQ document).; Other: Beta Testing (Observational Procedure); Participants will provide feedback on the refined version of the patient decision aid (short video and FAQ document).; Other: Youth Screening Pathway & Brief Follow-Up Interview (Observational Procedure); Youth participants will take screening surveys for early bipolar risk detection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Complete Youth Screening	Time in minutes required for youth participants to complete the assigned remote mental health screening battery.	16 Months
Youth and Caregiver Post-Screening Feedback Score	Mean post-screening feedback score from youth and caregiver surveys assessing clarity, comfort, perceived burden, and usefulness of the screening process. Items are rated from 1 to 5, with 1 indicating strongly disagree and 5 indicating strongly agree. Higher scores indicate more favorable feedback.	16 Months
Safety Flag Rate	Percentage of screened youth whose responses trigger the study safety protocol based on pre-specified screening thresholds.	16 Months
Risk Stratification Category Distribution	Percentage of screened youth assigned to each pre-specified risk category based on the fixed-item and adaptive screening algorithm. Categories may include low, moderate, or elevated risk.	16 Months

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: The Texas Child Mental Health Care Consortium (TCMHCC)
• Investigators: Principal Investigator: Karabi Nandy, PhD, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: February 21, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: bipolar disorder; bipolar I; bipolar II; bipolar disorder screening
• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Mental Disorders; Mood Disorders; Bipolar Disorder
• Other Study ID Numbers: STU20251974

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No