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Therapies for Children With Autism Spectrum Disorders

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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: Overall ratings: Overall ratings:<br />

Coniglio et al., Porcine secretin admini- • Met DSM-IV criteria <strong>for</strong> CARS total score, CARS total score,<br />

2001<br />

stered IV (test dose of 0.1 diagnosis of autism mean ± SD: 3 weeks, mean ±<br />

Country: ml; if no acute<br />

• CARS score ≥ 30 G1: 42.4 ± 5.4<br />

US<br />

anaphylactic reaction in • Total PLS-3 ≤ 60 months G2: 41.3 ± 6.3<br />

Practice 1 minute, 2.0 CU/kg Exclusion criteria: GARS autism<br />

setting:<br />

(maximum of 75 CU) • See inclusion criteria quotient, mean ±<br />

Academic administered over 1 Age, months ± SD: SD:<br />

Intervention minute)<br />

G1: 84.6 ± 25.2<br />

G1: 104.1 ± 15.4<br />

setting:<br />

Assessments:<br />

G2: 83.5 ± 28.9<br />

G2: 108.1 ± 11.9<br />

Clinic<br />

1 pre-injection and 2 post- Mental age:<br />

PLS total age,<br />

Enrollment injection developmental/ NR<br />

months ± SD:<br />

period:<br />

behavioral assessments: Gender, %:<br />

G1: 15.4 ± 9.5<br />

NR<br />

Presence or absence of Male:<br />

G2: 22.0 ± 12.8<br />

Funding: normal development G1: 73<br />

<strong>Children</strong>’s in early infancy and any G2: 77<br />

Healthcare of associated gastro- Female:<br />

Atlanta<br />

intestinal disturbances G1: 23<br />

Foundation Per<strong>for</strong>med by 4<br />

G2: 27<br />

Author industry evaluators (2 clinical Race/ethnicity, %:<br />

relationship psychologists, 1 White:<br />

disclosures: advanced psychology G1: 80<br />

NR<br />

graduate student, 1 G2: 77<br />

Design: developmental<br />

African American:<br />

RCT (method of pediatrician)<br />

G1: 17<br />

randomization not Groups:<br />

G2: 13<br />

described) G1: secretin<br />

Other:<br />

G2: placebo (saline) G1: 3<br />

Co-interventions held G2: 10<br />

stable during treatment: SES:<br />

No; approximately 7% of Maternal education: NR<br />

parents indicated that Household income: NR<br />

they had started a new Diagnostic approach:<br />

treatment regimen since In Study<br />

beginning the study Diagnostic tool/method:<br />

Frequency of contact DSM-IV criteria were<br />

during study:<br />

assessed <strong>for</strong> each child to<br />

At screening and provide documentation of<br />

injection, and at 3 and 6 the diagnosis of autism<br />

weeks post-injection be<strong>for</strong>e study entry<br />

Concomitant therapies: Diagnostic category, %:<br />

NR<br />

<strong>Autism</strong>:<br />

N at enrollment: G1: 50<br />

G1: 30<br />

G2: 52<br />

G2: 30<br />

PDD:<br />

N at follow-up:<br />

G1: 24<br />

G1: 28<br />

G2: 14<br />

G2: 29<br />

SD:<br />

G1: 39.2 ± NR<br />

G2: 41.9 ± NR<br />

G1/BL: P = 0.051<br />

CARS total score,<br />

6 weeks, mean ±<br />

SD:<br />

G1: 41.8 ± NR<br />

G2: 41.7 ± NR<br />

ANOVA: time &<br />

treatment (P =<br />

NS)<br />

Improvement in<br />

CARS total scores<br />

BL to 6 weeks, %:<br />

G1: 36<br />

G2: 28<br />

G1/G2: P = NS<br />

GARS autism<br />

quotient, 3 weeks,<br />

mean ± SD:<br />

G1: 92 ± NR<br />

G2: 99 ± NR<br />

GARS autism<br />

quotient, 6 weeks,<br />

mean ± SD:<br />

G1: 92 ± NR<br />

G2: 99 ± NR<br />

ANOVA: time (P =<br />

0.000) treatment<br />

(P = NS)<br />

PLS total age, 3<br />

weeks, months ±<br />

SD:<br />

G1: 16 ± NR<br />

G2: 21 ± NR<br />

PLS total age, 6<br />

weeks, months ±<br />

SD:<br />

G1: 17 ± NR<br />

G2: 21 ± NR<br />

ANOVA: time &<br />

treatment (P =<br />

NS)<br />

Coniglio et al.,<br />

<strong>Autism</strong> and PDD:<br />

Social skills:<br />

2001 (continued)<br />

G1: 24<br />

Parent reported<br />

G2: 36<br />

changes in social<br />

Aspergers:<br />

behavior or<br />

G1: 0<br />

language, %:<br />

G2: 0<br />

G1: 67<br />

Other characteristics:<br />

G2: 42<br />

DSM-IV diagnostic<br />

Medical:<br />

characteristics, %:<br />

Parent-reported<br />

C-391

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