En centerbaseret undersøgelse af pivotal responsbehandling for førskolebørn med autisme (PRT-C)
Et centerbaseret randomiseret kontrolleret forsøg med pivotal responsbehandling for førskolebørn med autisme
The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based environment to treat social communication deficits in children with autism spectrum disorder (ASD).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based preschool environment to treat social communication deficits in children with autism spectrum disorder (ASD). The study will compare Pivotal Response Treatment (PRT) to a delayed treatment group (DTG). PRT is a naturalistic behavioral intervention based on the principles of applied behavior analysis which has shown to be effective in treating the core deficits in children with ASD. The study will compare the combination of parent training with intensive center-based PRT (PRT-C) to a DTG and will include 44 children ages 2 to 3.11 years with ASD and social communication deficits.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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California
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Stanford, California, Forenede Stater, 94305
- Stanford University School of Medicine
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Diagnosis of Autism Spectrum Disorder (ASD) based on clinical interview and Diagnostic and Statistical Manual, 5th edition (DSM-5) and confirmed using the Autism Diagnostic Interview Revised (ADI-R) and Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) or Childhood Autism Rating Scale (CARS-2); Diagnostic and Statistical Manual, 5th edition (DSM-5), and expert clinical opinion
- Boys and girls between 2 years and 3 years and 11 months
- Ability to participate in the testing procedures to the extent that valid standard scores can be obtained
- Stable treatment (e.g., applied behavior analysis (ABA), speech therapy, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation
- Developmentally delayed with Mullen Scales of Early Learning (MSEL) or Developmental Profile (DP-4) composite score below 85 (1 Standard Deviation below the mean)
- Availability of at least one English-speaking parent who can consistently participate in parent training and research measures.
Exclusion Criteria:
- Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.)
- Presence of active medical problem (e.g., unstable seizure disorder or heart disease)
- Child primary language other than English
- Previous adequate trial of Pivotal Response Treatment
- More than 15 hours per week of in-home applied behavior analysis (ABA).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intensive Center-Based Pivotal Response Treatment (PRT-C)
Intensive Center-Based Pivotal Response Treatment (PRT-C) will consist of a combination of one weekly 60-minute individual parent training session and 12 weekly hours ( 3 hours per day for 4 days per week) with the child in center-based therapy environment for a total of 13 weekly treatment hours. |
Intensive Center-Based Pivotal Response Treatment (PRT-C) will consist of a combination of weekly individual parent training sessions and center-based therapy for a total of 13 weekly treatment hours. |
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Ingen indgriben: Delayed Treatment Group (DTG)
Delayed Treatment Group will consist of treatment as usual. At the end of controlled phase, participants in the DTG will be offered PRT-C in a preschool setting in an open-label fashion with a design similar to the double-blind phase. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Gennemsnitlig ændring fra baseline på Social Responsiveness Scale-2 Total Score efter 12 uger
Tidsramme: Baseline og uge 12
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Baseline og uge 12
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Gennemsnitlig ændring fra baseline på den samlede score for Brief Observation of Communication Change (BOSCC) efter 12 uger
Tidsramme: Baseline og uge 12
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Baseline og uge 12
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Gennemsnitlig ændring fra baseline på frekvensen, hvis barnets funktionelle ytringer på den strukturerede laboratorieobservation ved 12 uger
Tidsramme: Baseline og uge 12
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Baseline og uge 12
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Gennemsnitlig ændring fra baseline på Vineland Adaptive Behavior Scales 3rd Edition Socialization subscale ved 12 uger
Tidsramme: Baseline og uge 12
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Baseline og uge 12
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Gennemsnitlig ændring fra baseline på MacArthur-Bates Communication Development Inventory efter 12 uger
Tidsramme: Baseline og uge 12
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Baseline og uge 12
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Antonio Y. Hardan, MD, Stanford University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB-49033
Plan for individuelle deltagerdata (IPD)
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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