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Effects of risperidone and parent training on adaptive functioning in children with pervasive developmental disorders and serious behavioral problems . OBJECTIVE Children with Pervasive Developmental Disorders ( PDDs ) have social interaction deficits , delayed communication , and repetitive behaviors as well as impairments in adaptive functioning . Many children actually show a decline in adaptive skills compared with age mates over time . METHOD This 24-week , three-site , controlled clinical trial randomized 124 children ( 4 through 13 years of age ) with PDDs and serious behavioral problems to medication alone ( MED ; n = 49 ; risperidone 0.5 to 3.5 mg/day ; if ineffective , switch to aripiprazole was permitted ) or a combination of medication plus parent training ( PT ) ( COMB ; n = 75 ) . Parents of children in COMB received an average of 11.4 PT sessions . Standard scores and Age-Equivalent scores on Vineland Adaptive Behavior Scales were the outcome measures of primary interest . RESULTS Seventeen subjects did not have a post-randomization Vineland assessment . Thus , we used a mixed model with outcome conditioned on the baseline Vineland scores . Both groups showed improvement over the 24-week trial on all Vineland domains . Compared with MED , Vineland Socialization and Adaptive Composite Standard scores showed greater improvement in the COMB group ( p = .01 and .05 , and effect sizes = 0.35 and 0.22 , respectively ) . On Age Equivalent scores , Socialization and Communication domains showed greater improvement in COMB versus MED ( p = .03 and 0.05 , and effect sizes = 0.33 and 0.14 , respectively ) . Using logistic regression , children in the COMB group were twice as likely to make at least 6 months ' gain ( equal to the passage of time ) in the Vineland Communication Age Equivalent score compared with MED ( p = .02 ) . After controlling for IQ , this difference was no longer significant . CONCLUSION Reduction of serious maladaptive behavior promotes improvement in adaptive behavior . Medication plus PT shows modest additional benefit over medication alone . Clinical trial registration information-RUPP PI PDD : Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders ; http : //www.clinicaltrials.gov ; NCT00080145 .
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Intervention_Pharmacological
risperidone
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Intervention_Educational
and parent training
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Intervention_Pharmacological
medication alone
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Intervention_Pharmacological
risperidone
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Intervention_Pharmacological
aripiprazole
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Intervention_Pharmacological
combination of medication
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Intervention_Psychological
parent training
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Intervention_Educational
( PT )
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Intervention_Educational
PT sessions
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Intervention_Pharmacological
Medication
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Intervention_Psychological
PT
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Intervention_Pharmacological
medication alone
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Outcome_Mental
Vineland Socialization and Adaptive Composite Standard scores
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Outcome_Mental
Socialization and Communication domains
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Outcome_Mental
Vineland Communication Age Equivalent score
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Participant_Condition
children with pervasive developmental disorders and serious behavioral problems .