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Comparing Parent-Implemented Interventions for Toddlers With Autism Spectrum Disorders

25 juli 2022 uppdaterad 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

82

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Florida
      • Tallahassee, Florida, Förenta staterna, 32306
        • Florida State University
    • Michigan
      • Ann Arbor, Michigan, Förenta staterna, 48109
        • University of Michigan

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

1 år till 1 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Child measures of autism symptoms, social communication, developmental level, and adaptive behavior
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2007

Primärt slutförande (Faktisk)

1 maj 2013

Avslutad studie (Faktisk)

1 januari 2014

Studieregistreringsdatum

Först inskickad

25 september 2008

Först inskickad som uppfyllde QC-kriterierna

25 september 2008

Första postat (Uppskatta)

26 september 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 juli 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 juli 2022

Senast verifierad

1 februari 2014

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Early Social Interaction Project- PII

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