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.
Age: 18 years or older.
Confirmation of a lifetime Bipolar I or II diagnosis
Parent status: Has at least one biological child aged 7-21 years.
Capacity and willingness to consent: Able and willing to provide informed consent.
None
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
Family-based
Prospective
Co-design Workshop (Observational Procedure)
Other interventionParticipants 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.
Alpha Testing (Observational Procedure)
Other interventionParticipants will provide feedback on the initial version of the patient decision aid (short video and FAQ document).
Beta Testing (Observational Procedure)
Other interventionParticipants will provide feedback on the refined version of the patient decision aid (short video and FAQ document).
Youth Screening Pathway & Brief Follow-Up Interview (Observational Procedure)
Other interventionYouth participants will take screening surveys for early bipolar risk detection.
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.
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.
Youth Screening Uptake Rate
Percentage of eligible caregivers who consent for youth mental health screening after participation in the decision-aid workflow.
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.
Time to Complete Youth Screening
Time in minutes required for youth participants to complete the assigned remote mental health screening battery.
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.
Safety Flag Rate
Percentage of screened youth whose responses trigger the study safety protocol based on pre-specified screening thresholds.
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.
Click on the lead sponsor to view all of their trials.
University of Texas Southwestern Medical Center
Lead sponsor
The Texas Child Mental Health Care Consortium (TCMHCC)
Collaborator
