- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00004449
Randomized Study of Intensive One-on-one Behavioral Treatment for Preschool Aged Children With Autism
Randomized Study of Intensive One-on-one Behavioral Treatment Versus Individualized Parent Training in Preschool Aged Children With Autism
OBJECTIVES: I. Determine the effectiveness of intensive one-on-one behavioral treatment in the home or neighborhood compared with at home, individualized, parent training in preschool aged children with autism.
II. Identify intake measures that predict differences in outcome between subjects in the experimental group.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
PROTOCOL OUTLINE: This is a randomized study. Children are randomized to receive either 35 hours of intensive one-on-one behavioral treatment in the home and neighborhood for 2 years or individualized, in home parent training for 6 months.
A common group of tests to evaluate autism are administered at intake, 12 and 24 months into treatment, and when patients reach age 6.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
INCLUSION CRITERIA:
--Disease Characteristics--
Diagnosis of autism based on the Autism Diagnostic Interview using the ICD-10 research criteria
Ratio IQ score greater than 35 determined from the Bayley Scales of Infant Development
--Patient Characteristics--
Other:
Must reside within 60 km (37.5 miles) of a treatment site
EXCLUSION CRITERIA:
Severe medically induced limitations defined as:
- Any condition requiring prosthetic devices (e.g., blindness, deafness, or cerebral palsy)
- Any illness that has prevented or would prevent a subject from participating in 30 hours a week of treatment for six consecutive weeks or more (e.g., metastasized cancer or end stage renal disease)
- Any known genetic disorder (e.g., Fragile X, PKU, or Down Syndrome)
- Any other disorder that rules out autism according to ICD-10 criteria (e.g., Rett's Syndrome)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Wechsler Preschool and Primary Scales of Intelligence, 3rd ed.
Tidsramme: yearly for up to 4 years
|
IQ
|
yearly for up to 4 years
|
|
Bayley Scales of Infant Development
Tidsramme: yearly for up to 4 years
|
Alternate cognitive test administered to participants who did not achieve basal on WPPSI-III
|
yearly for up to 4 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Merrill-Palmer Scale of Mental Tests
Tidsramme: yearly for up to 4 years
|
Nonverbal cognitive skills
|
yearly for up to 4 years
|
|
Reynell Developmental Language Scales
Tidsramme: yearly for up to 4 years
|
Language comprehension and expressive language
|
yearly for up to 4 years
|
|
Vineland Adaptive Behavior Scales - Survey Edition
Tidsramme: yearly for up to 4 years
|
Parent interview on child's adaptive functioning
|
yearly for up to 4 years
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studieleder: Tristram Smith, Ph.D., University of Rochester
Publikationer og nyttige links
Generelle publikationer
- Cohen H, Amerine-Dickens M, Smith T. Early intensive behavioral treatment: replication of the UCLA model in a community setting. J Dev Behav Pediatr. 2006 Apr;27(2 Suppl):S145-55. doi: 10.1097/00004703-200604002-00013.
- Sallows GO, Graupner TD. Intensive behavioral treatment for children with autism: four-year outcome and predictors. Am J Ment Retard. 2005 Nov;110(6):417-38. doi: 10.1352/0895-8017(2005)110[417:IBTFCW]2.0.CO;2.
- Hayward D, Eikeseth S, Gale C, Morgan S. Assessing progress during treatment for young children with autism receiving intensive behavioural interventions. Autism. 2009 Nov;13(6):613-33. doi: 10.1177/1362361309340029.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01MH048863 (U.S. NIH-bevilling/kontrakt)
- UCLA-HSPC-G930506611
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