A Data-Driven Approach to Early Mental Health Screening in Offspring of Parents With Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
Background and Rationale:
Bipolar disorder (BD), characterized by acute mood fluctuations between manic and depressive states, affects approximately 5.7 million adults each year in the United States and is the fourth leading cause of disability among those aged 10-24 worldwide. BD is estimated to inflict an annual economic burden of $195 billion in the United States alone. Despite its high prevalence and significant impact on both disability and the economy, BD is typically diagnosed 11-17 years after symptom emergence. This results in delayed intervention, increased morbidity, and an elevated suicide risk.
While the etiology of BD is unknown, there is substantial evidence suggesting that it is associated with genetic, epigenetic, and neurochemical factors. Heritability is well established. A child who has a biological parent with BD is at a 15-30% risk of developing the disorder, and the risk increases to 50-75% when both parents are affected. This familial risk is widely recognized and presents a compelling opportunity for preventive measures, particularly during the prodromal phase, prior to the realization of full diagnostic criteria.
Purpose:
The purpose of this research is to develop and evaluate a stakeholder-informed, scalable screening approach in a pilot feasibility study for early identification of mental health risk in youth (ages 7-21) who have a biological parent with bipolar disorder (BD). Despite well-documented genetic risk, there is currently no established protocol to support family-initiated screening in this high-risk group.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Group A - Parent with Bipolar Disorder:
- •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.
- •Inclusion Criteria for Group B - Adult Caregiver:
- •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.
- •Inclusion Criteria for Group C - At-Risk Youth:
- •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
排除标准
- 未提供
研究者
Karabi Nandy
Professor of Biostatistics & Psychiatry
University of Texas Southwestern Medical Center