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Comparing Parent-Implemented Interventions for Toddlers With Autism Spectrum Disorders

25. juli 2022 oppdatert av: Amy M. Wetherby, Florida State University

Effects of Parent-Implemented Intervention for Toddlers With Autism Spectrum (The ESI Study)

This study will compare the effectiveness of two parent-based programs for helping young children at risk of autism.

Studieoversikt

Detaljert beskrivelse

Autism is a problem with normal social development and is characterized by impairments in three categories: social skills, language, and behavior. Symptoms include disinterest or inability to have normal social relationships, abnormal speech or usage of phrases, and repetitive movements or rituals; these symptoms generally emerge by 18 months of age. Autism is a spectrum disorder, meaning that its symptoms can range in severity from mild to severe. There is no cure for autism, nor is there a single known cause. There are only factors known to make it more likely for children to develop autism. These include being a male, having siblings with the disorder, having certain other disorders, or having an older father. Treatments for autism generally include therapies that help children develop social communication skills and that help structure family time and school so that parents and teachers can address particular difficulties children with autism might have. Medications may also be used to counteract anxieties or compulsive behaviors.

Research has shown that earlier interventions in children who are at risk of autism may lead to better outcomes. This study will compare two interventions for developing social communication skills in children who are at risk of autism and are between 16 and 20 months old. The parent-implemented intervention (PII) will be a more intense, individualized approach, teaching parents to embed 25 hours of social communication skills practice per week in their children's daily lives. The information, education, and support (IES) intervention will offer parents a support group and place to practice methods of helping their children learn adaptive social communication.

Participation in this study will last 18 months. Participants will be randomly assigned to first receive 9 months of either PII or IES and then receive 9 months of whichever intervention they did not receive initially. The PII intervention will involve three weekly sessions for 7 months, then two weekly sessions for 2 months. The IES intervention will involve group meetings twice monthly and offer a playground where parents can practice intervention strategies with their children. All parents will complete questionnaires about family resources and social and emotional issues before the first intervention begins, after 9 months when the intervention changes, and after 18 months when the second intervention ends. Children and parents will also be assessed once a month throughout the study on social communication, autism symptoms, developmental level, and hours spent on learned strategies or techniques outside the study visits. These assessments will involve clinical assessments of parent and child behaviors (some of which will be videotaped), tests of children's abilities, and reports by parents on strategies and techniques used outside the clinic.

Studietype

Intervensjonell

Registrering (Faktiske)

82

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Florida
      • Tallahassee, Florida, Forente stater, 32306
        • Florida State University
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

1 år til 1 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Presence of autism risk factors and a clinical diagnosis of autism spectrum disorder based on a diagnostic evaluation conducted by the project team
  2. Families agree to twice monthly play group sessions for 9 months and two to three intervention sessions per week for 9 months, usually to be scheduled within workday hours
  3. Families agree to monthly evaluations, videotaping of intervention sessions, and weekly or monthly video checks during the 18 months of treatment

Exclusion Criteria:

  1. Child does not have normal hearing or adequate motor control to make simple actions, such as giving and reaching gestures
  2. Primary language of family is not English

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: ESI--Individual PII First Condition
This group will first receive the Early Social Interaction (ESI) model individual parent-implemented intervention (PII) for 9 months, followed by the ESI model group information, education, and support (IES) intervention for 9 months.
The PII is an intensive, individualized treatment that teaches parents how to support social communication skills in children with autism by embedding skills practice within everyday routines, activities, and places. Participants will have three 75-minute sessions weekly with study administrators for the first 7 months of the study. Participants will then have two sessions per week for the final 2 months of the study. Children will also practice socialization embedded in normal activities for 25 hours a week outside of study visits.
The IES intervention provides access to a support group meeting twice monthly for children with autism and their parents. The support group provides information to families and a playgroup where parents may practice intervention strategies under the supervision of study officials knowledgeable about autism spectrum disorders.
Eksperimentell: ESI--Group IES First Condition
The group will first receive ESI group IES condition for 9 months, followed by ESI individual PII for 9 months.
The PII is an intensive, individualized treatment that teaches parents how to support social communication skills in children with autism by embedding skills practice within everyday routines, activities, and places. Participants will have three 75-minute sessions weekly with study administrators for the first 7 months of the study. Participants will then have two sessions per week for the final 2 months of the study. Children will also practice socialization embedded in normal activities for 25 hours a week outside of study visits.
The IES intervention provides access to a support group meeting twice monthly for children with autism and their parents. The support group provides information to families and a playgroup where parents may practice intervention strategies under the supervision of study officials knowledgeable about autism spectrum disorders.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Child measures of autism symptoms, social communication, developmental level, and adaptive behavior
Tidsramme: Measured before treatment, at crossover, and after treatment; some of these measures also will be taken every other month
Measured before treatment, at crossover, and after treatment; some of these measures also will be taken every other month

Sekundære resultatmål

Resultatmål
Tidsramme
Parent report measures of family functioning, daily hassles, and treatment satisfaction
Tidsramme: Measured before treatment, at crossover, and after treatment
Measured before treatment, at crossover, and after treatment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Amy M. Wetherby, PhD, Florida State University
  • Hovedetterforsker: Catherine Lord, PhD, University of Michigan

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2007

Primær fullføring (Faktiske)

1. mai 2013

Studiet fullført (Faktiske)

1. januar 2014

Datoer for studieregistrering

Først innsendt

25. september 2008

Først innsendt som oppfylte QC-kriteriene

25. september 2008

Først lagt ut (Anslag)

26. september 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. juli 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. juli 2022

Sist bekreftet

1. februar 2014

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • R01MH077730 (U.S. NIH-stipend/kontrakt)
  • DDTR B2-MBA (Annet stipend/finansieringsnummer: National Institute of Mental Health)
  • 1R01MH077730-01A2 (U.S. NIH-stipend/kontrakt)
  • 1R01MH078165-01A2 (U.S. NIH-stipend/kontrakt)

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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