Table 1. Participant Demographics and Clinical Measures at Intake.
| Demographic , Mean (SD) | ITT Cohort (n = 71) | Treatment Group (n = 40) | Control Group (n = 31) | P Value |
|---|---|---|---|---|
| Age, y | 8.38 (2.46) | 8.63 (2.52) | 8.74 (1.79) | .33 |
| Male, No. (%) | 63 (89) | 37 (92) | 16 (89) | .26 |
| Diagnosis, No. (%) | ||||
| ASD (using Diagnostic and Statistical Manual of Mental Disorders [Fifth Edition]) | 68 (96) | % (38 (95) | 30 (97) | .72 |
| Asperger (using Diagnostic and Statistical Manual of Mental Disorders [Fourth Edition]) | 3 (4) | 2 (5) | 1 (3) | .72 |
| Comorbidity, No. (%) | ||||
| Comorbid psychological diagnosis | 24 (34) | 13 (33) | 11 (35) | .80 |
| Comorbid neurological condition(s), including seizures, traumatic brain injury, or concussion | 6 (8) | 4 (10) | 2 (6) | .60 |
| Only diagnosed with an ASD | 41 (58) | 23 (58) | 18 (58) | .75 |
| Race/ethnicity, No. (%) | ||||
| White/European American | 25 (35) | 13 (33) | 12 (39) | .59 |
| Black | 2 (3) | 1 (3) | 1 (3) | .86 |
| East Asian/Asian American | 17 (24) | 10 (25) | 7 (23) | .82 |
| South Asian/Indian Americanb | 6 (8) | 1 (3) | 5 (16) | .04a |
| Middle Eastern/Arab American | 1 (1) | 0 (0) | 1 (3) | .26 |
| Native American/Alaskan Native | 0 (0) | 0 (0) | 0 (0) | |
| Hispanic/Latino/Spanish origin | 16 (23) | 8 (20) | 8 (36) | .57 |
| Unknown/not listed | 12 (17) | 9 (23) | 3 (10) | .16 |
| Concurrent therapy enrollment, No. (%) | ||||
| Applied behavior analysis | 71 (100) | 40 (100) | 31 (100) | |
| Social skills therapy | 34 (46) | 18 (24) | 16 (52) | .59 |
| Special education classes | 44 (59) | 23 (31) | 21 (68) | .39 |
| Speech language pathology | 58 (78) | 31 (42) | 27 (87) | .31 |
| Occupational therapy | 31 (42) | 18 (24) | 13 (42) | .80 |
| Currently enrolled in 2 of the above therapies | 65 (92) | 36 (90) | 24 (77) | .15 |
| Currently enrolled in 3 of the above therapies | 50 (70) | 28 (70) | 18 (58) | .30 |
| Currently enrolled in 4 of the above therapies | 35 (49) | 18 (45) | 11 (35) | .43 |
| Not currently enrolled in therapy | 0 (0) | 0 (0) | 0 (0) | |
| Social Communication Questionnaire | 24.14 (5.02) | 23.43 (5.13) | 25.06 (4.81) | .18 |
| Stanford Binet abbreviated IQ, total standard score | 77.76 (21.53) | 75.70 (20.71) | 80.42 (22.61) | .36 |
| NEPSY-II Affect Recognition subscale, scaled scorec | 6.65 (4.16) | 6.34 (3.98) | 7.07 (4.29) | .49 |
| Emotion Guessing Game scorec | 23.65 (11.54) | 22.80 (11.52) | 24.74 (11.66) | .49 |
| Child Behavior Checklistb | ||||
| Total problems | 67.22 (7.36) | 65.95 (7.16) | 69.04 (7.39) | .10 |
| Internalizing problems | 63.34 (8.25) | 62.76 (8.42) | 64.19 (8.09) | .50 |
| Externalizing problems | 62.08 (8.78) | 60.89 (8.46) | 63.77 (9.12) | .20 |
| Anxiety/depression | 61.14 (8.58) | 60.65 (8.43) | 61.85 (8.90) | .59 |
| Withdrawal/depression | 66.51 (8.10) | 66.62 (7.84) | 66.35 (8.63) | .90 |
| Somatic complaints | 57.84 (7.80) | 56.92 (6.64) | 59.15 (9.19) | .27 |
| Social problems | 65.53 (6.44) | 64.78 (5.82) | 66.58 (7.20) | .28 |
| Thought problems | 69.37 (8.98) | 68.69 (9.25) | 70.31 (8.68) | .49 |
| Attention problems | 71.33 (10.85) | 70.59 (10.62) | 72.38 (11.30) | .52 |
| Rule-breaking behavior | 60.23 (7.04) | 58.69 (6.12) | 62.35 (7.78) | .04a |
| Aggressive behavior | 63.30 (9.07) | 62.27 (9.31) | 64.77 (8.68) | .29 |
| Social Responsiveness Scale, intake scorec | ||||
| Total scorec | 80.71 (9.53) | 80.68 (8.41) | 80.76 (10.98) | .98 |
| Social awareness | 74.53 (10.00) | 75.50 (9.50) | 73.28 (10.66) | .37 |
| Social cognition | 77.22 (9.53) | 77.08 (8.19) | 77.41 (11.19) | .89 |
| Social communication | 80.25 (9.97) | 80.24 (9.56) | 80.28 (10.65) | .99 |
| Social motivation | 71.94 (11.05) | 72.63 (11.20) | 71.03 (11.00) | .56 |
| Restricted and repetitive behavior | 79.55 (11.63) | 78.53 (10.71) | 80.90 (12.80) | .41 |
| Vineland Adaptive Behavioral Scales II, intake score | ||||
| Adaptive behavior composite score | 72.81 (11.80) | 71.45 (12.66) | 74.63 (10.48) | .27 |
| Communication | 75.44 (12.38) | 73.83 (12.82) | 77.60 (11.63) | .21 |
| Daily living skills | 78.49 (16.08) | 76.23 (15.16) | 81.50 (17.01) | .18 |
| Socializationc | 69.46 (15.19) | 68.75 (16.63) | 70.40 (13.26) | .66 |
| Motor skills | 86.09 (15.44) | 86.40 (15.72) | 85.67 (15.31) | .85 |
Abbreviations: ASD, autism spectrum disorder; ITT, intention to treat; NEPSY-II, A Developmental Neuropsychological Assessment, Second Edition.
a
P value was under .05 between cohorts from a 2-tailed t test.
b
Only the number of South Asian/Indian American participants and the Child Behavior Checklist baseline Rule-Breaking Behavior subscale scores were significantly different between cohorts.
c
Primary outcome measure.