FOCUS Bipolar: Families Opening Conversations for Understanding Signs

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07622927
Status
Recruiting
Apply to this trial

Conditions

  • Bipolar Disorder (BD)
  • Bipolar Disorder Family Members
  • Bipolar Disorder I or II
  • Screening Tool

Eligibility Criteria

Sex
ALL
Age
7 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Co-design Workshop (Observational Procedure) — OTHER
    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.
  • Alpha Testing (Observational Procedure) — OTHER
    Participants will provide feedback on the initial version of the patient decision aid (short video and FAQ document).
  • Beta Testing (Observational Procedure) — OTHER
    Participants 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
    Youth participants will take screening surveys for early bipolar risk detection.

Study Details

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.

Key Dates

Start date
Mar 11, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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
  • Arm: 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

Primary Outcome Measure

Decision Aid Acceptability Score [ Time Frame: 16 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIP
UT Southwestern Medical CenterDallasTexas75390

Find similar trials in Dallas, TX

By research site
UT Southwestern Medical Center· Dallas, TX

Related Studies