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Early mental health screening for children of parents with bipolar disorder

Tests a family-centered screening approach for youth with a bipolar parent.

Key facts

Who runs it
University of Texas Southwestern Medical Center
Where
Dallas, United StatesSee the site
Trial code
Registry title
FOCUS Bipolar: Families Opening Conversations for Understanding Signs
Status
Recruiting
People taking part
200 people, planned
Started
11 Mar 2026
Expected to end
31 Jul 2027
Type of study
Observational, 3 groups
Treatments tested
  • Co-design Workshop (Observational Procedure)
  • Alpha Testing (Observational Procedure)
  • Beta Testing (Observational Procedure)
  • Youth Screening Pathway & Brief Follow-Up Interview (Observational Procedure)
Record updated
3 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for families affected by bipolar disorder: parents with bipolar I or II, their adult caregivers, and children and young people with a parent who has it.

Age
Parents and caregivers: 18 years or older. Youth: 13-18 years in the design and testing phases, 7-21 years in the screening phase.
Sex
All sexes can join.
Disease stage
Parents must have a lifetime bipolar I or II diagnosis confirmed by a clinician. Youth must not currently have bipolar I or II.

Main reasons for not taking part

  • Cannot give informed consent because of cognitive impairment or language barriers
  • Acute psychiatric instability at enrolment, such as acute psychosis or acute suicidality without stabilization
  • A medical or psychiatric condition that the study doctor judges would put the person at undue risk or interfere with standard care
  • Youth who currently have a bipolar I or II diagnosis
  • Cannot read, speak and understand English

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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; 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:
  • Unable to provide informed consent due to cognitive impairment or language barriers
  • Experiencing acute psychiatric instability at enrollment (e.g., acute psychosis or acute suicidality without stabilization)
  • 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

Where in United States

  • UT Southwestern Medical CenterDallas, United StatesContact: Karabi Nandy, Ph.D.Taking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 3 groups in the trial

  • 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

    Treatment: Co-design Workshop (Observational Procedure), Alpha Testing (Observational Procedure), and Beta Testing (Observational Procedure)

  • 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

    Treatment: Co-design Workshop (Observational Procedure), Alpha Testing (Observational Procedure), and Beta Testing (Observational Procedure)

  • 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

    Treatment: Co-design Workshop (Observational Procedure), Alpha Testing (Observational Procedure), Beta Testing (Observational Procedure), and Youth Screening Pathway & Brief Follow-Up Interview (Observational Procedure)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Data-Driven Approach to Early Mental Health Screening in Offspring of Parents With Bipolar Disorder
Plain-language title
Early mental health screening for children of parents with bipolar disorderGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
3 June 2026