FOCUS Bipolar: Families Opening Conversations for Understanding Signs

Overview

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.

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.