Bipolar Disorder (BPD) Clinical Trials

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A Data-Driven Approach to Early Mental Health Screening in Offspring of Parents With Bipolar Disorder

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Healthy Volunteers: t
View:

• 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.

• Study participation: Able to comply with study procedures (e.g., co-design sessions, interviews, assessments).

• Language: Able to read, speak, and understand English.

• Age: 18 years or older.

• 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.

• Capacity and willingness to consent: Able and willing to provide informed consent.

• Study participation: Able to comply with study procedures (e.g., co-design sessions, interviews, assessments).

• Language: Able to read, speak, and understand English.

• Age:

‣ Phase 1 (co-design) and Phase 2A (alpha testing): 13-18 years

⁃ Phase 2B (beta testing): 13-18 years

⁃ Phase 3 (screening): 7-21 years

• Diagnosis status: Must not have a current diagnosis of Bipolar I or II disorder.

• 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).

• Consent/Assent:

‣ For youth aged 18-21: Able and willing to provide informed consent (verbal)

⁃ For youth aged 7-21: Parent/guardian/LAR able and willing to provide informed consent (verbal) and youth able to provide assent (verbal)

• Participant ability: Able and willing to participate in study activities (e.g., co-design discussions, questionnaires, or screening assessments.

• Language: English sufficient to comprehend study procedures and materials.

Locations
United States
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Karabi Nandy, Ph.D.
FOCUSBipolar@UTSouthwestern.edu
214-648-4490
Backup
Karabi Nandy, Ph.D.
FOCUSBipolar@UTSouthwestern.edu
214-648-9551
Time Frame
Start Date: 2026-03-11
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 200
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: The Texas Child Mental Health Care Consortium (TCMHCC)
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov