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Therapies for Children With Autism Spectrum Disorders

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Appendix C. Evidence Tables<br />

Tables are sorted by year, then last name of first author.<br />

Evidence Table. <strong>Therapies</strong> <strong>for</strong> children with ASD<br />

Study<br />

Inclusion/Exclusion Baseline<br />

Description Intervention<br />

Criteria/Population Measures Outcomes<br />

Author:<br />

Intervention:<br />

Inclusion criteria: Social skills: Social skills:<br />

Akhondzadeh et Pentoxifylline +<br />

• Between 4 and 12 years ABC-C<br />

ABC-C<br />

al. 2010<br />

risperidone or placebo + of age<br />

Lethargy/Social Lethargy/Social<br />

Country: risperidone <strong>for</strong> 10 weeks • Met DSM-IV-TR criteria <strong>With</strong>drawal, mean ± <strong>With</strong>drawal, mean<br />

Iran<br />

Practice<br />

setting:<br />

Academic<br />

Intervention<br />

setting:<br />

outpatient clinic<br />

Enrollment<br />

period:<br />

April 2007–April<br />

2009<br />

Funding:<br />

Tehran University<br />

of Medical<br />

Sciences<br />

Author industry<br />

relationship<br />

disclosures:<br />

NR<br />

Design: RCT<br />

(Double-blind,<br />

parallel group)<br />

<strong>for</strong> Autistic Disorder SD:<br />

± SD:<br />

Risperidone titration: • Outpatients from a G1: 18.27 ± 2.97 G1:<br />

• up to 2 mg/day in specialty clinic <strong>for</strong> G2: 17.29 ± 3.23 Week 10:<br />

children weighing children at a psychiatric<br />

8.03 ± 3.64<br />

between 10 -40 kg (0.5 teaching hospital Communication/ G2:<br />

mg starting dosage with Exclusion criteria: language: Week 10:<br />

0.5 mg increments in • concomitant<br />

ABC-C<br />

13.05 ± 1.93<br />

weekly dosage <strong>for</strong> first 3 schizophrenia or Inappropriate G1 and G2<br />

weeks)<br />

psychotic disorders Speech, mean ± significantly<br />

• 3 mg/day <strong>for</strong> children • history of drug or alcohol SD:<br />

different based on<br />

>40 kg<br />

abuse<br />

G1: 5.13 ± 0.83 groups x time<br />

Pentoxiphylline titration: • history of tardive<br />

G2: 4.94 ± 0.92 interaction (P ≤<br />

• 400 mg/day increase <strong>for</strong> dyskinesia<br />

0.0001)<br />

children weighing • received neuroleptics or<br />

Repetitive<br />

between 10-40 kg (200<br />

behavior:<br />

Communication/<br />

other psychotropic drug<br />

mg starting dose with 6 months prior to<br />

ABC-C Stereotypic language:<br />

100 mg increments recruitment<br />

Behavior, mean ± ABC-C<br />

every 2 days)<br />

SD:<br />

Inappropriate<br />

• significant active medical<br />

• 600 mg (300mg starting<br />

G1: 8.01 ± 1.30 Speech, mean ±<br />

problem<br />

dose with 100 mg<br />

G2: 7.72 ± 1.44 SD:<br />

• severe or profound<br />

increments every 2<br />

G1:<br />

mental retardation<br />

days) <strong>for</strong> children >40<br />

Problem behavior: Week 10:<br />

precluding definitive<br />

kg.<br />

ABC-C<br />

2.08 ± 0.94<br />

diagnosis of autism<br />

Hyperactivity/nonco G2:<br />

Age, mean/yrs ± SD<br />

Placebo:<br />

mpliance, mean ± Week 10:<br />

(range):<br />

• matched <strong>for</strong> shape,<br />

SD:<br />

3.73 ± 0.55<br />

G1: 8.05 ± 2.01 (4-11)<br />

size, color and taste<br />

G1:16.03 ± 2.60 G1 and G2<br />

G2: 7.37 ± 2.41 (4-12)<br />

G2:15.44 ± 2.88 significantly<br />

Mental age: NR<br />

Assessments:<br />

different based on<br />

Gender:<br />

Aberrant Behavior<br />

ABC-C Irritability, groups x time<br />

M, n (%):<br />

Checklist-<br />

mean ± SD: interaction (P ≤<br />

G1: 15 (75)<br />

Community (ABC-C),<br />

G1: 16.67 ± 2.71 0.0001)<br />

G2: 14 (70)<br />

Extrapyramidal Symptoms<br />

G2: 16.06 ± 3.00<br />

F, n (%):<br />

Rating Scale (ESRS) G1: 5 (25)<br />

G2: 6 (30)<br />

Groups:<br />

G1: pentoxifylline +<br />

risperidone<br />

G2: placebo + risperidone<br />

Co-interventions held<br />

stable during treatment:<br />

NR (no psychosocial<br />

therapies during trial)<br />

Race/ethnicity:<br />

NR<br />

SES:<br />

NR<br />

Diagnostic approach:<br />

Referral and confirmed In<br />

study by child psychiatrist<br />

C-1

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