RUPP PI PDD: Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders

Conditions

Child Development Disorders, Pervasive

Keywords

Autistic Disorder, Asperger Syndrome

Brief summary

This 24-week study will compare the safety and effectiveness of medication treatment alone (risperidone or aripiprazole) to medication treatment in combination with a parent management training program.

Detailed description

PDD can be a profoundly disabling condition across social, emotional, and academic domains. Safe and effective treatments for PDD are needed. Participants are randomly assigned to receive either risperidone plus parent management training or risperidone alone for 24 weeks. Participants who show deterioration at Week 4 will be offered an alternative mediation treatment, aripiprazole. These participants will remain in their original treatment group (either med alone or med plus parent management training). After 6 months of treatment (Week 24), participants who respond to their treatment will be gradually discontinued from their medication treatment to learn if the response can be sustained without continued medication treatment (This phase of the study was ended in Nov. 2006) Adaptive and behavioral outcomes are assessed during the study.

Scahill L, Jeon S, Boorin SJ, McDougle CJ, Aman MG, Dziura J, McCracken JT, Caprio S, Arnold LE, Nicol G, Deng Y, Challa SA, Vitiello B.

2016-03-0752 citations

10.1016/j.jaac.2016.02.016

Iron Homeostasis During Risperidone Treatment in Children and Adolescents

Chadi A. Calarge, Ekhard E. Ziegler, Nicole Del Castillo, Michael Aman, Christopher J. McDougle et al. (8 authors)

The Journal of Clinical Psychiatry2015-08-0318 citations

10.4088/jcp.14m09258

Effects of risperidone and parent training on adaptive functioning in children with pervasive developmental disorders and serious behavioral problems.

Scahill L, McDougle CJ, Aman MG, Johnson C, Handen B, Bearss K, Dziura J, Butter E, Swiezy NG, Arnold LE, Stigler KA, Sukhodolsky DD, Lecavalier L, Pozdol SL, Nikolov R, Hollway JA, Korzekwa P, Gavaletz A, Kohn AE, Koenig K, Grinnon S, Mulick JA, Yu S, Vitiello B, Research Units on Pediatric Psychopharmacology Autism Network.

2011-12-2366 citations

10.1016/j.jaac.2011.11.010

Interventions

DRUGRisperidone

BEHAVIORALBehavior Therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 13 Years

Healthy volunteers

No

Inclusion criteria

* Autistic Disorder, Asperger's Disorder, or Pervasive Developmental Disorder not otherwise specified * Weight \> 30 lbs * IQ \>= 35 or mental age of at least 18 months

Exclusion criteria

* Psychotic Disorder * History of intolerance or nonresponse to risperidone * Pregnancy * History of neuroleptic malignant syndrome

Design outcomes

Primary

Measure	Time frame
Home Situations Questionnaire	Week 24
Vineland Daily Living Skills Scale	Week 24

Secondary

Measure	Time frame
Irritability subscale-Aberrant Behavioral Checklist	Week 24
Clinical Global Impressions-Improvement (CGI-I)	Week 24

Countries

United States

Outcome results

None listed