Actively Recruiting
Early Intervention for Youth at High Risk for Bipolar Disorder
Led by University of Pittsburgh · Updated on 2026-01-28
120
Participants Needed
1
Research Sites
295 weeks
Total Duration
On this page
Sponsors
U
University of Pittsburgh
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Investigators will conduct a confirmatory efficacy trial of Interpersonal and Social Rhythm Therapy (IPSRT) delivered via telehealth for offspring of bipolar parents (OBP; age 12-18, n=120) at elevated risk for BP onset via risk calculator score. All participants receive a baseline clinical assessment of psychiatric symptoms and sleep disturbance (via objective and subjective methods), followed by a feedback session. Youth are then randomized to receive 8 sessions of IPSRT or a manualized Healthy Lifestyle Behaviors Program (HL) delivered via secure videoconference. As clinically indicated, youth are offered Community Treatment Referral (CTR) for any psychiatric symptoms/disorders identified at intake. Primary outcome domains over 18 months include mania and affective lability. Investigators will also further investigate the hypothesized mechanism underlying IPSRT (i.e., sleep/circadian disruption) across levels of analysis, and the contribution of interpersonal stress to sleep/circadian disruptions. Application of Implementation Science methods throughout maximizes ultimate scalability and feasibility if efficacious. Investigators will also examine whether passive cellphone sensing may serve as a portable, cost-effective measure of mechanisms and outcomes to enhance ultimate dissemination.
CONDITIONS
Official Title
Early Intervention for Youth at High Risk for Bipolar Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12-18 years
- A parent with a diagnosis of bipolar disorder type I or II
- Baseline Risk Calculator score greater than 0.05
- Able and willing to give informed consent or assent
You will not qualify if you...
- A lifetime diagnosis of bipolar disorder type I or II
- Current unstabilized psychiatric symptoms
- Evidence of developmental disorder or central nervous system disorder
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nicole Arnold
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
N
Nicole Arnold, MA
CONTACT
P
Pamala Pyle
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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