New screening approach could help kids at risk for bipolar disorder
NCT ID NCT07622927
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a new way to help families decide if their children should be screened for early signs of mental health problems. The children are ages 7 to 21 and have a parent with bipolar disorder. The researchers are creating a video and FAQ to help parents understand the risks and make informed choices. They will also test if remote screening is practical and acceptable for these families.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to better tools for early detection of mental health issues in children at risk for bipolar disorder, potentially allowing for earlier support and intervention.
- What could go wrong
- This is an early-stage observational study focused on developing and testing screening tools, not a treatment trial. The results may not directly improve outcomes, and the screening tools may not be widely adopted or effective in all settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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
- Ages
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7 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UT Southwestern Medical Center
RECRUITINGDallas, Texas, 75390, United States
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