- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02595697
Communication Intervention for Toddlers With Autism (J-EMT)
An Efficacy Trail of Enhanced Milieu Teaching Language Intervention Plus Joint Attention, Engagement, Regulation Intervention for Toddlers With Autism
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study tests the blended intervention (J-EMT) in a parent-plus-therapist-implementation model that has been demonstrated to be effective with other populations.
The J-EMT communication intervention is tailored to the specific social communication characteristics of children with ASD and is delivered during a critical period in early communication development for these children.
In this study, the investigators compare this blended intervention (J-EMT) to a business as usual (BAU) comparison group. Children assigned to the J-EMT group will receive a total of 48, 1-hour direct intervention sessions over six months that will include teaching their parents to implement J-EMT procedures across daily activities.
The investigators will examine social communication and child vocalizations, expressive and receptive language, symbolic play, and symbol-infused joint engagement to determine whether J-EMT changes both a primary functional outcome and the underlying specific skills that contribute to effective social communication in children with ASD.
Results from this study will indicate the efficacy of this variation of parent-plus-therapist-implemented EMT (i.e., J-EMT) specifically tailored to the characteristics of young children with ASD.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Illinois
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Evanston, Illinois, Forente stater, 60208
- Northwestern University
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Tennessee
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Nashville, Tennessee, Forente stater, 37203
- Vanderbilt University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Between 24 and 36 months of age
- A diagnosis of ASD as confirmed by the ADOS-2 (module 1)
- Signed informed consent
- Parent willing to be trained
Exclusion Criteria:
- Other diagnosis or disability
- Abnormal hearing and/or vision
- Language other than English is the primary language spoken at home
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: Kontrollgruppe Business as Usual
Alle barn, uavhengig av gruppeoppgave vil delta i alle vurderinger.
Barn randomisert til kontrollgruppen vil ikke motta intervensjon, men vil fullføre alle andre forskningsprosedyrer.
Andre behandlinger som alle barn mottar i samfunnet vil bli registrert med undersøkelser hver annen måned.
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Eksperimentell: J-EMT for Toddlers with Autism
The J-EMT intervention:(a) teach foundational social communicative behaviors, (b) teach related skills that predict long term language outcomes, (c) teach a range of communicative functions, (d) target specific spoken language skills as well as foundational skills, (e) incorporate instructional methods, contexts, and partners that increase social use of language in natural contexts, and (f) promote generalization and maintenance of newly learned skills to everyday activities and routines.
In addition, because parents are essential partners for young children with ASD who are learning to communicate, studies are needed that (g) include parents and (h) specify the method and fidelity of parent instruction and fidelity and dosage with which parents use the trained strategies
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Children assigned to the J-EMT group will receive a total of 48, 1-hour direct intervention sessions over six months that will include teaching their parents to implement J-EMT procedures across daily activities.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of spontaneous social communication attempts made as assessed by a 20 minute lanugage sample.
Tidsramme: 6 months
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6 months
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R324A150094
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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