Pilot Randomized Controlled Trial of Omega-3 and Individual-Family Psychoeducational Psychotherapy for Children and Adolescents With Depression.

The goal of this study is to evaluate feasibility and estimate effect sizes of omega-3 fatty acids (Ω3), individual-family psychoeducational psychotherapy (PEP), their combination, and moderating effects of maternal depression and psychosocial stressors in youth with depression. In a pilot 2 × 2 randomized controlled trial, 72 youth (ages 7-14; 57% Caucasian, 57% male) with major depression, dysthymia, or depression not otherwise specified were randomized to 12 weeks of Ω3, PEP+placebo, Ω3+PEP, or placebo. Ω3 versus placebo was double-masked. Evaluators masked to condition assessed depressive severity at baseline (randomization) and at 2, 4, 6, 9, and 12 weeks using the Children's Depression Rating Scale-Revised. Side effects were either absent or mild. PEP was administered with 74% fidelity. Remission was 77%, Ω3+PEP; 61%, PEP+placebo; 44%, Ω3; 56%, placebo. Intent-to-treat analyses found small to medium effects of combined treatment (d = .29) and Ω3 monotherapy (d = .42), but negligible effect for PEP+placebo (d < .10), all compared to placebo alone. Relative to placebo, youth with fewer social stressors responded better to Ω3 (p = .04), PEP (p = .028), and their combination (p = .035), and those with maternal depression responded better to PEP (p = .020) than did those without maternal depression. Remission rates were favorable compared to other studies of psychotherapy and comparable to an existing randomized controlled trial of Ω3; results warrant further evaluation in a larger sample. Ω3 was well tolerated. Active treatments show significantly more placebo-controlled depression improvement in the context of maternal depression and fewer stressors, suggesting that they may benefit depression with a more endogenous than environmental origin.

Predicting Therapeutic Effects of Psychodiagnostic Assessment Among Children and Adolescents Participating in Randomized Controlled Trials.

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.

Predicting enrollment in two randomized controlled trials of nonpharmacologic interventions for youth with primary mood disorders.

BACKGROUND: As recruitment and retention are often challenging in randomized controlled trials (RCTs), this study sought to identify predictors of participation (i.e., trial enrollment). METHOD: These analyses identified predictors of enrollment among 119 youth, ages 7-14, with a primary mood disorder, who screened eligible for the Omega-3 and Therapy pilot studies; 95 (79.8%) actually participated in the treatment. RESULTS: Youth who received some form of travel assistance (16.0%) almost uniformly enrolled in the treatment portion of the RCT. Youth who lived further away from the study site (p = .047) or whose primary caregiver never married (p = .01) were less likely to enroll. Of note, socioeconomic status (SES) variables (parent education and child insurance status) did not significantly predict enrollment, suggesting that study incentives or accommodations may have adequately addressed barriers commonly associated with SES. LIMITATIONS: Due to the fairly high trial enrollment rate (approximately 80%), there likely was limited power to detect some differences between groups. Generalizability may be limited to youth with a primary mood disorder diagnosis. CONCLUSIONS: Despite retaining a large proportion of the youth who screened eligible, participant self-selection is a limitation of any RCT. A silent inclusion criterion of any RCT is willingness to be randomized.

Omega-3 Fatty Acid Plasma Levels Before and After Supplementation: Correlations with Mood and Clinical Outcomes in the Omega-3 and Therapy Studies.

OBJECTIVE: To examine fatty acid profiles, their response to omega-3 fatty acid (Ω3) supplementation, and associations with clinical status and treatment response in youth with mood disorders. METHODS: In a placebo-controlled 2X2 design, 7-14 year-olds (N = 95) in parallel pilot trials (depression N = 72; bipolar N = 23) were randomly assigned to 12 weeks of Ω3 supplementation (1.4 g eicosapentaenoic acid [EPA], 0.2 g docosahexaenoic acid [DHA], and 0.27 g other Ω3 per day); psychoeducational psychotherapy (PEP); their combination; or placebo (mainly oleic and linoleic acid) alone. Blood was drawn at baseline (N = 90) and endpoint (n = 65). Fatty acid levels were expressed as percent of total plasma fatty acids. Correlational and moderator/mediator analyses were done with SPSS Statistics 23. RESULTS: At baseline: (1) DHA correlated negatively with alpha-linolenic acid (ALA) (r = -0.23, p = 0.029); (2) Arachidonic acid (AA, Ω6) correlated negatively with global functioning (r = -0.24, p = 0.022); (3) Total Ω3 correlated negatively with age (r = -0.22, p = 0.036) and diastolic blood pressure (r = -0.31, p = 0.006). Moderation: Baseline ALA moderated response to Ω3 supplementation: ALA levels above the sample mean (lower DHA) predicted significantly better placebo-controlled response (p = 0.04). Supplementation effects: Compared to placebo, 2 g Ω3 per day increased EPA blood levels sevenfold and DHA levels by half (both p < 0.001). Body weight correlated inversely with increased EPA (r = -0.52, p = 0.004) and DHA (r = -0.54, p = 0.003) and positively with clinical mood response. Mediation: EPA increase baseline-to-endpoint mediated placebo-controlled global function and depression improvement: the greater the EPA increase, the less the placebo-controlled Ω3 improvement. CONCLUSION: Ω3 supplementation at 2 g/day increases blood levels substantially, more so in smaller children. A possible U-shaped response curve should be explored.

Theory of Mind Predicts Emotion Knowledge Development in Head Start Children.

RESEARCH FINDINGS: Emotion knowledge (EK) enables children to identify emotions in themselves and others and its development facilitates emotion recognition in complex social situations. Social-cognitive processes, such as theory of mind (ToM), may contribute to developing EK by helping children realize the inherent variability associated with emotion expression across individuals and situations. The present study explored how ToM, particularly false belief understanding, in preschool predicts children's developing EK in kindergarten. Participants were 60 3- to 5-year-old Head Start children. ToM and EK measures were obtained from standardized child tasks. ToM scores were positively related to performance on an EK task in kindergarten after controlling for preschool levels of EK and verbal ability. Exploratory analyses provided preliminary evidence that ToM serves as an indirect effect between verbal ability and EK. PRACTICE OR POLICY: Early intervention programs may benefit from including lessons on ToM to help promote socio-emotional learning, specifically EK. This consideration may be the most fruitful when the targeted population is at-risk.