Purpose: This report characterizes children enrolled to date (enrollment ends 5/31/14) in two NIH-funded trials examining omega3 fatty acids (Ω3) and individual family psychoeducational psychotherapy (IF-PEP) in treating children aged 7 to 14 with depression or bipolar disorder-not otherwise specified.
Methods: 385 families have been prescreened. 205 were eligible for face-to-face screens, 141 attended, 94 (66.6%) were eligible (64 for OATS-D, 31 for OATS-B). Exclusions: not meeting study criteria (39, 41%), unable to swallow pills (7, 5%) or started medications (1). Referral sources were: 34.6%, advertisements; 25.6%, clinicians; 16.7%, behavioral health intake at local children's hospital; 6.5%, word of mouth; 5.1%, school; 3.9%, parallel study; and 7.6%, miscellaneous.
Results: Demographics were widely dispersed–Combined family income: 26.9%, <$20,000; 41%, $20,000 to $60,000; 12.8%, $60,000 to $100,000; and 16.7%, >$100,000. Primary caregiver education: 18%, ≤ high school education; 25.6%, some college; 43.6%, associate's/bachelor's degree; 11.5%, graduate or professional training. Primary insurance status: 60%, private insurance; 36%, Medicaid; 4%, self-pay. Family history of mood disorder symptoms was common (depression, 89.7%; mania, 52.6%). Children had multiple comorbidities (number of diagnoses=4.0±1.2, range: 1 – 6). Families had pursued 1.7 (±1.4) outpatient treatments and had tried 1.6 (±2.0) psychotropic medications for their children, 4% had ≥ 1 prior psychiatric hospitalization. Health problems included: 38.6%, stomachache; 24.4%, decreased appetite; 20.5%, increased appetite; 20.5%, nausea/vomiting; 16.8%, constipation; and 9%, diarrhea. Children had average height (65%), BMI and weight (69%). Children were randomized into a 12-week trial, with ¼ receiving IF-PEP and Ω3; ¼ receiving IF-PEP and placebo; ¼ receiving active monitoring and Ω3; and ¼ receiving active monitoring and placebo. Rate of study drop-out were lowest for those in combined treatment (n=3) and highest for those in Ω3 and active monitoring (n=6).
Conclusion: Nonpharmacologic intervention was of interest to a wide range of families.
Contact: Mary Fristad, mary.fristad@osumc.edu
