Abstract
This study explored predictors of improvement after completing a psychodiagnostic screening assessment but before randomization among youth who participated in two pilot randomized controlled trials of omega-3 supplementation and Individual-Family Psychoeducational Psychotherapy (PEP). Ninety-five youth (56.8% male, 61.1% White) ages 7–14 with mood disorders completed screening and baseline assessments (including Clinical Global Impressions–Improvement [CGI-I], Children’s Depression Rating Scale–Revised, Young Mania Rating Scale), then were randomized into a 12-week trial of omega-3, PEP, their combination, or placebo. Between screening and randomization, 35.8% minimally improved (CGI-I = 3), 12.6% much improved (CGI-I < 3), totaling 48.4% improved. Caregiver postsecondary education (p = .018), absence of attention-deficit/hyperactivity disorder (p = .027), and lower screen depression severity (p = .034) were associated with CGI-I. Caregiver postsecondary education (p = .020) and absence of a disruptive behavior diagnosis (p = .038) were associated with depression severity improvement. Prerandomization improvement moderated treatment outcomes: Among youth who improved prerandomization, those who received PEP (alone or with omega-3) had more favorable placebo-controlled depression trajectories due to a lack of placebo response. This open-label trial of psychodiagnostic assessment provides suggestive evidence that psychodiagnostic assessment is beneficial, especially for those with depression and without externalizing disorders. Prerandomization improvement is associated with better placebo-controlled treatment response. Future research should test alternative hypotheses for change and determine if less intensive (shorter and/or automated) assessments would provide comparable results.
ACKNOWLEDGMENTS
We thank the staff who collected data and provided therapy; the families who participated; and OmegaBrite, who provided study capsules.
Declaration of Interest
Dr. Arnold received research funding from Curemark, Forest, Lilly, Neuropharm, Novartis, Noven, Shire, and YoungLiving (as well as NIH and Autism Speaks) and has consulted with or been on advisory boards for Arbor, Gowlings, Neuropharm, Novartis, Noven, Organon, Otsuka, Pfizer, Roche, Seaside Therapeutics, Sigma Tau, Shire, Tris Pharma, and Waypoint; Dr. Arnold received travel support from Noven. Dr. Fristad receives royalties from Guilford Press, American Psychiatric Press, and Child & Family Psychological Services. She has received honoraria from Physicians Postgraduate Press and the American Occupational Therapy Association.
FUNDING
This research was supported by awards from the National Institute of Mental Health (R34 MH090148 and R34 MH85875); the content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.