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

Abstract

Objective 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). Method Ninety-five youth (56.8% male, 61.1% white) aged 7–14 with mood disorders completed screening and baseline assessments (including Clinical Global Impressions-Improvement [CGI-I], Children’s Depression Rating Scale-Revised [CDRS-R], Young Mania Rating Scale [YMRS]), then were randomized into a 12-week trial of omega-3, PEP, their combination, or placebo. Results Between screening and randomization, 35.8% minimally improved (CGI-I=3), 12.6% much improved (CGI-I<3), totaling 48.4% improved. Caregiver post-secondary education (p = .018), absence of attention-deficit/hyperactivity disorder (p = .027), and lower screen depression severity (p = .034) were associated with CGI-Improvement. Caregiver post-secondary education (p = .020) and absence of a disruptive behavior diagnosis (p = .038) were associated with depression severity improvement. Pre-randomization improvement moderated treatment outcomes: among youth who improved pre-randomization, those who received PEP (alone or with omega-3) had more favorable placebo-controlled depression trajectories due to a lack of placebo response. Conclusions This open-label trial of psychodiagnostic assessment provides suggestive evidence that psychodiagnostic assessment is beneficial, especially for those with depression and without externalizing disorders. Pre-randomization 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.

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

“…Although at screen all youths’ depression symptom severity fell within the clinical range (CDRS-R range= 40-76), at baseline, participants demonstrated mild depressive symptoms as indicated by mean CDRS-R scores of 42, just above the standard clinical cutoff for this measure of depressive severity. Initial assessment procedures appear to have impacted improvement (Young et al, in press). Nevertheless, this pilot study is unique in having tested the separate and combined impact of a nutritional intervention with a family-based psychosocial intervention.…”

“…Baseline assessments were scheduled at least one week later at a time convenient for eligible families, averaging 3.5 ± 1.8 weeks after the screening assessment (range = 0.9 – 8.0; see Young, et al, in press for further details). Following the baseline assessment, eligible youth were randomized into one of four treatment arms: PEP+Ω3, n = 17; Ω3 monotherapy, n = 18; PEP+placebo (PBO), n = 19; or PBO alone, n = 18.…”

Body weight affects ω-3 polyunsaturated fatty acid (PUFA) accumulation in youth following supplementation in post-hoc analyses of a randomized controlled trial

“…(See Fig 1 for recruitment and selection flow chart). [27] Body parameter measurements and fasting blood samples were collected at the University Medical Center.…”

Is evidence‐based treatment helping my patient? Utilizing modified Brinley plots to measure clinical change.

“…Figure 11, for example, demonstrates how modified Brinley plots can be used to depict session-by-session changes in treatment outcome, as well as to compare multiple patients within the same graph. Finally, though all youth met study criteria with regard to symptom scores, many youth demonstrated significant improvement from the screening assessment alone (see Young et al, 2016); since the current analyses utilized baseline rather than screening data as the pretreatment scores, our ability to depict clinically significant change in the modified Brinley plots may have been limited by a floor effect. Patient B, in contrast, did not see any reliable or clinically significant change in his symptom scores during the 5 weeks of treatment.…”

“…Notably, this is less of a limitation when considering the session-by-session tracking of outcome measures, as every participant's score on the x-axis is fixed (pretreatment score) which creates a separate "line" of data for each individual. Finally, though all youth met study criteria with regard to symptom scores, many youth demonstrated significant improvement from the screening assessment alone (see Young et al, 2016); since the current analyses utilized baseline rather than screening data as the pretreatment scores, our ability to depict clinically significant change in the modified Brinley plots may have been limited by a floor effect.…”