Table 1.
Authors | Subjects | Design | Results | |||
---|---|---|---|---|---|---|
1. Jou et al., 2005 | 20 patients, including 16 M and 4 F (mean age = 11.5 years; SD = 3.5 years). 16 subjects (80%) with AD, 2 (10%) with ASP, and 2 (10%) with PDDNOS. 10 subjects (50%) had a diagnosis of intellectual disability (ID), 4 (20%) with mild ID, 4 (20%) with moderate ID, and 2 (10%) with severe ID. Most patients (80%) were taking at least 1 concomitant medication. | OL, case series. Retrospective case review. Review of outpatient clinic registry for individuals with PDDs. ATX initiated at 18 mg/day for 7 days. ATX then titrated up to target dose of 1.2 mg/kg/day. If no acceptable clinical response, dose was increased to a maximum of 1.4 mg/kg/day as tolerated. Subjects seen on average of once per month; phone calls were conducted on weekly basis during titration period. Duration mean= 19.5 weeks (SD = 10.5 weeks; Range, 1-36 weeks). Treatment response assessed using Improvement item of Clinical Global Impressions scale (CGI-I) based on the Conners’ Parent Rating Scale (CPRS) completed by primary caretakers and other clinical information in the registry. |
End-point (EP) dose was 43.3 mg on average (SD = 18.1 mg). a) 12 subjects (60%) judged to be responders, as defined by a score of 1 or 2 on the CGI-I. b)One patient discontinued ATX because of severe mood swings. Children's Psychiatric Rating Scale (CPRS): c)Conduct: BL= 10.5; EP= 8.1 (p = 0.01). d)Hyperactivity: BL= 17.1; EP= 13.0 (p = 0.001); ES=0.89. e)Inattention: BL= 7.5; EP= 5.8 (p = 0.01) f)Learning: (BL= 7.2 ; EP= 5.6 (p = 0.01). g)Psychosomatic: BL= 0.55; EP= 0.20 (p = 0.05)* h)Anxiety: BL= 3.7; EP= 3.2 (p = 0.09) AEs: Constipation (n=6), decreased appetite (n=6), ear ringing (n=6), mood swings (n=6), and sedation (n=6)were reported. One patient who discontinued ATX because of severe mood swings. Mean weight change was 0.36 ± 2.41 kg (range, −3.18 to 9.09 kg); 5 subjects experienced weight loss, 7 weight gain, and 8 no change. |
|||
2. Arnold et al, 2006 | 16 subjects (12M, 4F) age 5-15 (mean 9.3 yr), with ASD (7 AD, 8 PDDNOS) and DSM-IV ADHD syndrome. Diagnosed by DSM criteria and ADI-R. ABC Hyperactivity subscale score 25.0±12.07. ADHD symptom mean 1.91±0.54. 6 with concomitant meds, mostly antipsychotics | Double-blind, PBO-controlled, randomized-order crossover, 6 weeks each condition, 1-week washout between. Dose 20-100 mg/day, 1.0-1.4 mg/kg/day. |
Aberrant Behavior Checklist (ABC): a)Hyperactivity (primary): ATX, BL=24.69, EP=19.31; PBO, BL=22.50, EP=22.37, p=0.04, ES=0.74 b)Irritability: ATX BL=16.00, EP=13.06; PBO BL=14.18, EP=14.13, p=0.12, ES=0.61 c)Social Withdrawal: ATX BL=8.69, EP=6.5; PBO BL=6.62, EP=7.43, p=0.01, ES=1.18 d)Stereotypic Behavior: ATX BL=7.37, EP=4.69; PBO BL=6.19, EP=6.63, p=0.08, ES=0.87 e)Inappropriate Speech: ATX BL=5.75, EP=4.87; PBO BL=4.68, EP=5.43, p=0.28, ES=0.52 DSM-IV (SNAP): f)Inattentive: ATX BL=16.06, EP=11.20; PBO BL=14.81, EP=13.63, p=0.053, ES=0.89 g)Hyperactive-Impulsive: ATX BL=17.31, EP=10.40; PBO BL=14.88, EP=14.50, p=0.005, ES=1.27 h)Oppositional defiant: ATX BL=8.81, EP=6.07; PBO BL=8.83, EP=7.25, p=0.59, ES=0.20 Repetitive Behavior Scale–R (RBS–R): i) Stereotypy: ATX BL=8.56, EP=5.37; PBO BL=7.00, EP=6.56, p=0.11, ES=0.19 j) Self-injury: ATX BL=1.25, EP=1.88 PBO BL=2.13, EP=2.38, p=0.29, ES=0.65 k) Compulsions: ATX BL=4.25, EP=3.19; PBO BL=3.93, EP=4.13, p=0.07, ES=1.10 l) Rituals: ATX BL=10.50, EP=7.88; PBO BL=9.43, EP=9.31, p=0.13, ES=0.23 m) Restrictive ATX BL=4.06, EP=4.25; PBO BL=3.81, EP=4.13, p=0.75, ES=0.04 n) Total score: ATX BL=53.12, EP=43.50; PBO BL=49.06, EP=45.00, p=0.57, ES=0.09 Responders (CGI-I of 1-2, plus 25% improv't on ABC-Hyperactivity): ATX, 57% vs. placebo, 25%. Mean EP ATX dose= 44.2 mg/day. AEs: Heart Rate: ATX BL=88.5, EP=92.4; PBO BL=92.4, EP=84.1, p=0.005, ES=0.83 AEs higher for ATX than PBO: Nausea/vomiting/upset stomach (100% vs. 31%; p= .006); Fatigue (75% vs. 44%; p= .004) Racing heart (25% vs. 0%; p= .048) Appetite suppression (75% vs. 50%) Irritability (88% vs. 81%) One dropout on ATX; hospitalized for aggressive rage. Cognition: No effects on (a) Continuous Performance Task, (b) Match-To-Sample Task, or (c) Analogue Classroom Task. |
|||
3. Posey et al., 2006 | 17 enrolled, 16 analyzed; ages 6-14 years (mean=7.7±2.2); 7 AD, 7 ASP, 2 PDDNOS; 3 F, 13 M; non-verbal IQ 70-121 (M=93.9±18); no concomitant psychotropics during trial (2-4 weeks free prior to baseline); no medical conditions & no comorbid psychiatric disorders; ADI-R- & ADOS-confirmed diagnosis. | OL, uncontrolled; structured titration in first 3 wks. of 8-week trial (0.5 mg/kg/day-0.8 mg/kg/day to 1.2 mg/kg/day). If CGI-Improvement in week 4 <much improved, then dose to 1.4 mg/kg/day; flexibility to adjust dose down to decrease adverse effects (AEs). Outcomes: CGI, SNAP-IV & ABC 2-weekly; SRS, VABS, ADOS pre/post; CPT baseline, 4 & 8. | a)13 subjects completed 8 weeks, 12 (75%) considered responders. b)Weight decreased mean of 0.8 kg (p = 0.0006) c)CGI-Severity (CGI-S) BL= 5.1; EP= 3.9 (p = 0.0007) SNAP-IV Total d)Teachers BL= 29.6; EP= 12.8 (p <0.0001), ES=1.4 e)Parents BL= 44.4; EP= 22.6 (p <0.0001), ES=1.9 ABC Teachers f)Irritability: BL=8.8; EP= 2.4 (p=0.01, ns) g)Social Withdrawal: BL=10.3; EP= 5.3 (p=0.05, ns), ES=0.8 h)Stereotypic Behavior: BL= 6.5; EP= 4.3 (p=0.03, ns), ES=0.4 h)Hyperactivity: BL= 18.2; EP= 8.4 (p=0.004), ES=1.0 i)Inappropriate Speech: BL= 8.8; EP= 2.4 (p=0.01, ns), ES=0.9 Parents j) Irritability: BL= 14.3; EP= 8.5 (p=0.03, ns), ES=0.7 k) Social Withdrawal: BL= 13.0; EP= 8.6 (p=0.003), ES=0.8 l) Stereotypy: BL= 5.6; EP= 2.4 (p <0.0001), ES=1.1 m) Hyperactivity: BL= 28.4; EP= 14.2 (p <0.0001), ES=1.9 n) Inappropriate Speech: BL= 4.1; EP= 1.8 (p <0.0001), ES=1.0 SRS: 0) BL= 110.2; EP= 92.7 (p=0.005, ns), ES=0.9 VABS: p) Communication: BL= 67.7; EP= 66.4 (p=0.71, ns) q) Daily Living Skills: BL= 46.8; EP= 43.3 (p=0.70, ns) r) Motor Development: BL= 62.8; EP= 59.5 (p=0.76, ns) s) Adaptive Behavior Composite: BL= 54.4; EP= 5.3 (p=0.94, ns) t) Maladaptive Part 1: BL= 21.9; EP= 15.2 (p=0.0003), ES=1.0 u) Maladaptive Part 2: BL= 8.1; EP= 4.8 (p=0.003), ES=1.4 AEs: 1 subject withdrew (week 6) due to increased irritability, 1 after experiencing irritability, blunted affect, and nausea at lowest dose. No significant differences from BL to EP on CPT or ADOS raw scores. |
|||
4. Troost et al., 2006 | 12 children, ages 6-17 years (M=10.22, SD=2.82); with investigator-assigned diagnosis of ASD and high levels of parent-rated ADHD symptoms; 7 with autistic disorder, 4 with PDD-NOS, 1 with Asperger's Disorder; 4 with “average IQ,” 8 with “borderline IQ” | OL (10 weeks); semi-structured titration, with target dose of 1.2 mg/kg/day. Single daily dose in the morning or twice-daily divided dose. | Seven study completers, 10 with ≥ 6 weeks of participation. a)Primary: ADHD Rating Scale–Parent Rating (investigator completed): BL= 40.33; EP= 22.42; ES=2.3 Conners’ Parent Rating Scale–Revised: b)Oppositional: BL= 9.17; EP= 8.17 N.S. c)Cognitive Problems: BL= 12.42; EP= 9.33 (p= 0.05), ES= 0.66 d)Hyperactivity: BL= 9.83; EP= 6.67 (p= 0.05), ES= 0.65 e)ADHD Index: BL= 24.25; EP= 18.67 (p= 0.05), ES= 0.63 Aberrant Behavior Checklist f)Irritability: BL= 15.83; EP= 14.50 NS g)Social Withdrawal: BL= 8.92; EP= 7.17 NS h)Stereotypic Behavior: : BL= 3.42; EP= 2.58 NS i)Hyperactivity/Noncomp. : BL= 23.58; EP= 18.67 (p= 0.07), ES= 0.44 j) Inappropriate Speech: BL= 3.33; EP= 3.75 NS AEs: Five of the 12 subjects discontinued due to AEs: nausea (n=1), anxiety (n=1), aggression/agitation (n=1), nausea/vomiting (n=1), and loss of appetite/weight loss (3.3 kg) (n=1). Most common AEs were anorexia (n = 10), irritability (n = 9), sleeping problems (n = 7). |
|||
5. Tang et al., 2009 | 13-year-old boy, with ADHD Inattentive type; Wechsler Intelligence Scale for Children FS IQ= 66. No substance abuse. | N/A: Case report. Patient was initially treated with OROS methylphenidate, which was discontinued because of severe headache. Patient was slowly titrated up to 60 mg ATX over 4 weeks. |
AEs: Patient became suspicious, complained of being followed by strangers, heard voices talking about him. After discontinuance of ATX, all psychotic symptoms remitted. | |||
6. Fernández – Jaén et al., 2010 | 48 youth (32 boys, 16 girls), mean age = 8.8 years (range = 5 – 19 years). All subjects had ID (IQ < 62) and ADHD (DSM-IV-TR criteria). 4 subjects excluded due to nonadherence with protocol (2 because of missed appointments; 2 because they failed to “follow the methodology for monitoring treatment efficacy”). | 16-week, OL, prospective study. Approximate dose of 0.4 mg/kg/day during the Week 1, 0.8 mg/kg/day during Week 2, and 1.2 mg/kg/day at 3rd week (mean EP dose = 1.22; S.D. = 0.19 max. dose of 60 mg/day), single dose taken at breakfast. Assessed at BL and at 16 weeks on CGI-S, ADHD-RS-IV (Parents & Teachers); Conners’ Rating scale (short version; Parents & Teachers), at Week 16 on CGI-I. |
a) CGI-S: Mean scores statistically significant between BL and EP (BL = 5.31; EP= 4.13 (p < 0.001); ES=1.4 b) CGI-I: Of the 45 Ss who finished 16-week treatment period, 22 (49%) much improved or very much improved; 14 (31%) minimally improved; no change in 7 (16%); 1 (2%) minimally worse; 1 (2%) much worse. ADHD-RS-IV Parent ratings c)Inattention: BL= 19.50; EP= 13.4 (p <0.001) d)Hyperactivity-Impulsiveness: BL= 16.72; EP= 11.67 (p <0.001); ES=1.3 e)Total: BL= 36.22; EP= 25.07 (p <0.001) Teacher ratings f)Inattention: BL= 16.21; EP= 11.04 (<0.001) g)Hyperactivity-Impulsiveness: BL= 12.95; EP= 8.52 (p <0.001) h)Total: BL= 29.17; EP= 19.56 (p <0.001). Conners’ Rating Scale Parent ratings i)Inattention: BL= 11.02; EP= 7.94 (p <0.001) j) Hyperactivity: BL= 9.52; EP= 6.63 (p <0.001); ES= 1.1 k) Conduct Problem: BL= 11.75; EP= 8.88 (p<0.001); l) Total : BL= 32.30; EP= 23.47 (p <0.001) Teacher ratings m) Inattention: BL= 10.25; EP= 6.95 (p <0.001) n) Hyperactivity: BL= 8.15; EP= 5.50 (p 0.001) o) Behavior Issues:† BL= 9.45; EP= 6.05 (p<0.001) p) Total: BL= 27.85; EP= 18.50 (p <0.001) q) No association of age, sex, history of neuroleptic use, or methylphenidate use with ATX response. AEs: 15/48 (31%) presented with AEs. three of 48 (6%) were unable to complete titration due to excessive irritability; 12 of 48 (25%) exhibited one or more of the following: sleepiness (n=6, 12%), irritability (n=4, 8%), GI discomfort (n=3, 7%), anorexia (n=1, 2%). |
|||
7. Charnsil, 2011 | 12 children, ages 7-17 years (M=10.67, SD=2.96); with diagnosis of ASD based on investigator-completed CARS and DSM-IV-TR criteria. Sample characterized as having severe autistic disorder. ADHD based upon parent completed ABC, but no minimum cutoff reported. | OL: dose titration to 1.2 mg/kg. (given in morning, starting at 0.25 mg/kg/day and increased every 4-5 days by .3-.4 mg/kg/day as tolerated. 10-week trial and 1-month follow-up safety check. Measures; ABC by parent at baseline, Week 6 and Week 10. CGI-I by nurse at Week 10. Safety measures of weekly vitals and weight. Definition of response: 25% decrease on ABC-Hyperactivity subscale and CGI-I of 1 or 2. Eight of 12 subjects taking risperidone [plus fluoxetine (n=1), valproate (n=2) or diphenhydramine (n=1)] prior to and during the study. |
Average daily dose= 0.98 mg/kg/day (0.8-1.2 mg//kg/day). Three S's could only tolerate 0.8 mg/kg/day. .Three S's withdrew due to adverse effects (abdominal discomfort, irritable mood) during the first 2 weeks. Nine S's completed the study. a)CGI-I by study nurse: Much/Very much improved, n=5; 3 Mimimally improved, n=3; No change, n=1. (However, authors “concluded that atomoxetine was inefficient in reducing attention deficit in hyperactive symptoms” in these subjects due to lack of statistically significant improvement on the ABC-I and ABC-H subscales.. ABC Parent ratings: b)Irritability BL=27.11; EP=24.33 (p= .33), ES= .095 c)Social Withdrawal BL=23.44; EP=24.56 (p= .82), ES= .044 d)Stereotypic Behavior BL=11.78; EP=13.11 (p= .76), ES= .097 e)Hyperactivity BL=33.89; EP=31.78 (p= .34), ES= .29 f)Inappropriate Speech BL=3.11; EP=2.78 (p= .22), ES= .032 AEs: 11 subjects had AEs: decreased appetite (n=5), insomnia (n=3), moodiness (n=3); irritability (n=2); abdominal discomfort (n=1); diarrhea (n=1). |
|||
8. Mazzone et al., 2011 | 55 youth (53 male; 2 female), ages 5-15 years (mean = 9.9; SD = 2.4) with ADHD symptoms. 53 (96%) were Combined Type, 2 (4%) were Hyperactive/Impulsive Type based on DSM-IV-TR and ≥ 6 inattention and/or hyperactivity/impulsivity items rated “pretty much” on SNAP-IV. IQ ranged from 43-117 (mean = 80.6, SD = 18.6) (17 had ID). 49% of subjects had ODD. No comorbid ASD, anxiety or mood disorder. No prior history of medication | OL, retrospective case review, of variable duration, using medical records for all child/adolescent patients given ATX over 3½-year period. ATX initiated at 0.5 mg/kg/day, and increased based on response. Treatment duration was 1-168 weeks (mean = 57.3 weeks; SD = 39.45). Treatment outcome based on CGI–Improvement (CGI-I) and CGI–Severity (CGI-S). Final dose ranged from 0.32 to 1.76 mg/kg/day (mean= 1.28; SD = 0.39). | a)CGI-I was correlated with full IQ (r= −0.68, p < 0.01), Verbal IQ (r = −0.61, p < 0.01), and Performance IQ (r = −0.69, p < 0.01). b)CGI-I of 1 or 2 more likely in IQ≥85 group (20 of 26 subjects; 76.9%) than in IQ < 85 group (6 of 29 subjects; 20.7%), Fisher's exact test p < 0.001). c)Smaller response rate in ID (IQ < 70): only 1 in 17 responders; χ2 = 14.59; p < 0.01) compared to subjects with IQ >70. d)No difference between IQ subgroups in mean duration of treatment or dose. e)AEs: loss of appetite (n=13); abdominal pain (n=12); nausea (n=7); weight loss (n=4); vomiting (n=3); sleepiness (n=2); paraesthesia (n=1); and myadrasis (n=1). f)Discontinuance: 20 subjects stopped treatment due to no response or reservations about medication. |
|||
9. Zeiner, Gjevik, & Weidle (2011) | 14 subjects, ages 7-17 years (M=11.6 ± 3.5); with ASD and ADHD symptoms; 2 had AD, 8 had ASP; 4 PDDNOS; diagnosed with DSM-IV criteria alone. | OL; intent-to-treat (ITT) design; titration started at 0.5 mg/kg/day with upper limit of 1.4 mg/kg/day; 10-week trial; assessments every 14 days; statistical analyses= Wilcoxon Signed Ranks test |
Clinician-completed AD/HD-RS a)Inattention: BL= 21.00; EP= 14.79 (p = 0.003); ES=1.1 b)Hyp/Imp: BL= 16.43; EP= 10.36 (p = 0.001). Teacher-completed AD/HD-RS c)Inattention: BL= 16.00; EP= 12.80 (p = 0.012) d)Hyp/Imp: BL=10.46; EP= 6.90 (N.S.). Response rate e)Seven of 14 participants (50%) classified as clinical responders AEs f)Significant increase in heart rate from BL to EP 77.6±6.5 to 84.7± 7.3, p=0.03; nausea (n=5); headache (n=5); stomach ache (n=3); irritability (n=3); drowsiness (n=3); dizziness (n=2); compulsive behavior (n-1) |
|||
10. Harfter-kamp et al., 2012 | 102 enrolled, 97 analyzed; ages 6-17(ATX-mean=9.9, SD=2.7, range=6-16; PBO-mean=10.0, SD=2.9, range=6-17); 58 AD, 5 ASP, 32 PDDNOS, 2 No ASD; 83 M, 14 F; IQ 61-138; diagnoses confirmed through clinical assessment and ADI-R; IQ≥60, comorbidity was allowed except for psychosis or bipolar, no other psychoactive medications allowed | Double-blind, PBO-controlled design, structured titration in first 3 wks. of 8-week trial (0.5 mg/kg/day to 0.8 mg/kg/day to 1.2 mg/kg/day), ITT design. |
ADHD-RS (LOCF ANOVA)** a)Total score: ATX, BL=40.7, EP=31.2; PBO, BL=38.6, EP=38.3 (p<.001); ES=.93 b)Inattention: ATX, BL=20.7, EP=17.0; PBO, BL=20.6, EP=19.9 (p=.002) c)Hyperactivity/impulsivity: ATX, BL=20.0, EP=14.2; PBO, BL=17.9, EP=18.4 (p=.001); ES=1.0 CTRS-R:S Scores (LOCF ANCOVA) a)Oppositional: ATX, BL=4.1, EP=3.2; PBO, BL=3.6, EP=3.7 (p=.37) b)Hyperactivity: †† ATX-BL=8.8, EP=6.8; PBO-BL=8.2, EP=8.8 (p=.024) c)Cognitive/Attention: ATX, BL=6.8, EP=5.1; PBO, BL=4.8, EP=5.8 (p=.18) d)ADHD: ATX, BL=18.5, EP=15.1; PBO, BL=18.1, EP=17.8 (p=.077) CGI Much/Very much improved: ATX: n=9, PBO: n=4; Minimally improved: ATX: n=12, PBO, n=6; No change/Worse: ATX: n=22, PBO: n=36 AEs (Sig. differences listed first) ATX and PBO, respectively: Nausea: 14 vs. 4, p=.009 Decreased appetite: 13 vs. 3, p=.006 Early morning awakening: 5 vs. 0, p=.027 Headache: 12 vs. 9, p=.47 Fatigue: 11 vs. 4, p=.053 AEs higher for ATX than PBO, respectively: Upper abdominal pain: 9 vs. 3, p=.55 Abdominal pain: 4 vs. 3, p=.72 Dizziness: 3 vs. 1, p=.36 Influenza: 3 vs. 0, p=.12 Myalgia: 3 vs. 0, p=.12 |
|||
11. Harfter-kamp et al., 2013 | 88 subjects, 6-17 years of age (mean= 10.0); 51 AD, 5 ASP, 30 PDDNOS, 2 No ASD; 76 M, 12 F; IQ 61-138 (mean= 93.1); diagnoses confirmed through clinical assessment and ADI-R; IQ≥60, comorbidity was allowed except for psychosis or bipolar, no other psychoactive medications allowed. | 20-week, open-label, ITT extension, without breaking the double blind from the previous trial. Subjects were previously in an 8-week, controlled trial of ATX. 46 subjects previously received PBO, and 37 previously received ATX (see Harfterkamp et al., 2012). Titration was structured in first 3 wks. of 20-week trial (0.5 mg/kg/day [wk 1] to 0.8 mg/kg/day [wk 2] to 1.2 mg/kg/day [wk 3 and thereafter]). Subjects started on PBO in the blinded trial received a total of 20 weeks of ATX treatment; subjects assigned to ATX in blinded trial received a total of 28 weeks ATX treatment. |
ADHD-RS (paired sample t-tests); subjects originally assigned to ATX: a)Total score: ATX, Wk 8=32.4, EP=24.9; (p<.02) b)Inattention: ATX, Wk 8=16.9, EP=13.0; (p<.01) c)Hyperactivity/impulsivity: ATX, Wk 8=15.5, EP=11.8; (p<.06) Subjects originally assigned to PBO: Results not presented, although almost certainly statistically significant reduction in ADHD scores. Subjects originally assigned to both PBO and ATX: All comparisons were significant for both subscales and for Total score. AEs, reported from wk 8 of ATX and from EP (Wk 12 or 20 of ATX treatment) (N=88): |
|||
AE | First 8 Wks | After 12/20 Wks | P level | |||
abdominal pain | 6 | 2 | N.S. | |||
abdom. pain upper | 11 | 7 | N.S. | |||
decreased appetite | 16 | 8 | <.10 | |||
early awakening | 5 | 1 | N.S. | |||
fatigue | 16 | 6 | =.04 | |||
headache | 18 | 13 | N.S. | |||
influenza | 5 | 2 | N.S. | |||
initial insomnia | 6 | 6 | N.S. | |||
nausea | 12 | 1 | .003 | |||
vomiting | 6 | 5 | N.S. |
Abbreviations: ABC= Aberrant Behavior Checklist, AD= autistic disorder, ADOS= Autism Diagnostic Observation Schedule, AEs= adverse events ASP= Asperger's disorder, BL= baseline, bpm = beats per minute, CGI= Clinical Global Impressions scale, CPRS= Conners’ Parent Rating Scale, CPT= Continuous Performance Task, EP= end-point, F= female(s), ES= Cohen's d (effect size), ID= Intellectual disability, ITT= intent-to-treat, M= male(s), NS= non-significant/not significant, OL= open label, PDD= pervasive developmental disorder, PBO= placebo, PDDNOS= pervasive developmental disorder not otherwise specified, RBS-R= Repetitive Behavior Scale-Revised,
Alpha set at .01 to minimize Type I Error; actual p value = .05, nominally significant.
Results using LS Means, from mixed models for repeated measures (MMRM) not summarized, to enable consistent reporting of results; MMRM not reported in original paper for CTRS-R:S.
There is apparently no “Behavior Issues” subscale in the English or Spanish versions of the Conners’ scales, so it is unknown which items comprised this subscale. Also, although the researchers used a Spanish version, it is unclear what edition of Conners’ scales was used for the teachers ratings.
This appears to be the 7-item subscale on Conners’ Teacher Rating Scale—Short version. If scored in the usual way (0-3 convention), scores between 8-9 at baseline would be relatively low for symptoms of ADHD.