FOCUS Bipolar: Families Opening Conversations for Understanding Signs
Purpose
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.
Conditions
- Bipolar Disorder (BD)
- Bipolar Disorder I or II
- Bipolar Disorder Family Members
- Screening Tool
Eligibility
- Eligible Ages
- Over 7 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Criteria
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 Design
- Phase
- Study Type
- Observational
- Observational Model
- Family-Based
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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 |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Texas Southwestern Medical Center
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.
