KEY3 (Early Intervention for Youth at High Risk for the Development of Bipolar Disorder)

Principal Investigator: Tina Goldstein, PhD

Co-Investigators: Ellen Frank PhD, Boris Birmaher MD

The KEY study was funded by the National Institute of Mental Health (NIMH).

This study is no longer recruiting.

The most potent risk factor for the development of bipolar disorder is a first-degree family member with the illness. Thus, offspring of parents with bipolar disorder are a particularly high-risk group. It is well-established that poor sleep regulation is associated with the onset of depressive and manic episodes among individuals with a biological vulnerability to mood disorder. The proposed study aims to address this core disturbance that we argue puts at-risk youth at even greater risk for development of bipolar disorder—sleep and social rhythm disruption. We had previously conducted 2 treatment development/pilot trials (see Goldstein et al., 2014) to demonstrate the feasibility and acceptability of Interpersonal and Social Rhythm Therapy (IPSRT), an empirically-supported treatment for adults with bipolar disorder that helps patients stabilize sleep/wake cycles and daily routines, for at-risk adolescents. In KEY3, we conducted a pilot randomized trial of the intervention. Data collection for the KEY2 study was completed in May 2015, and data analyses are currently underway.